US cancer care: Treatment choices are all about you

US cancer experts are preparing to focus on new developments in making treatment ever more personalized, right down to the molecular level, at their main annual gathering this weekend.

 

"We have a theme at the meeting this year: personalizing cancer care, ranging from using molecular analysis to select the most appropriate treatment for patients through developing personalized survivalship care plans for cancer survivors," said Richard Schilsky, president of the American Society of Clinical Oncology (ASCO), which is holding its annual meeting in Orlando, Florida.

 

Worldwide, about 13 percent of deaths are caused by cancer. Results from dozens of clinical studies will be released at the gathering opening Friday and running through June 2. Some 30,000 people are expected to take part.

 

"I think it's clear to all of us who are treating cancer patients that oncology is no longer one-sided; it's all medicine," Schilsky said, noting that great strides had been made in selecting the best treatments for a given patient.

 

"We are increasingly able to tailor treatment to an individual," such as their particular tumor biology, "matching the right treatment to the right patient at the right time allowing patients to avoid unnecessary cost and side effects from therapy that won't help them," Schilsky stressed. "It's very clear to me that is the future of cancer medicine."

 

In total, 4,000 research works were accepted by ASCO on a broad range of topics in oncology, said Eric Winer, a Harvard University professor associated with the group.

 

Seven press conferences have been scheduled, including two on Saturday on the results of gastrointestinal tumors and advanced lung cancer research.

 

Two more are planned for Sunday to discuss results of breast cancer and ovarian cancer research, as well as personalized treatment plans.

 

On Monday, experts will discuss strides made in cancer care, as well as on current major challenges facing oncology.

 

Among the clinical results due out are phase two trial results on Nexavar, made by Germany's Bayer for advanced lung cancer treatment.

 

Nexavar, which works by blocking the growth of blood vessels feeding a tumor, leading to the death of some cancer cells, already is marketed in more than 70 countries as a liver cancer treatment.

 

Results are also awaited with interest on Avastin, a breast cancer treatment by US firm Genentech, which has been bought by Switzerland's Roche.

 

Cancer is a leading cause of death in the world, blamed for 7.4 million deaths in 2004, according to the World Health Organization (WHO). The deadliest cancers are lung, stomach, colon, liver and breast cancer.

 

About 30 percent of cancer deaths could be avoided, the WHO says, with smoking the leading lifestyle risk.

 

Cancer begins with the modification of a single cell -- and can be caused by external, genetic or hereditary factors, or a combination of these.

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Cyclacel Reports Initial Phase 2 Seliciclib Data in Patients With Nasopharyngeal Carcinoma At 2009 ASCO Annual Meeting

Cyclacel Pharmaceuticals, Inc. has announced interim data from the lead-in stage of a Phase 2 randomized clinical trial of oral seliciclib (CYC202), a novel cyclin dependent kinase (CDK) inhibitor, in patients with solid tumors and previously-treated nasopharyngeal carcinoma (NPC) at the 45th annual meeting of the American Society of Clinical Oncology (ASCO) (Abstract 6026). The data demonstrated that oral seliciclib could be safely administered in two dosing schedules which were well tolerated and met the criteria for proceeding to the randomized stage of the study. Seliciclib treatment resulted in prolonged stable disease in previously-treated NPC patients suggesting seliciclib inhibits tumor growth in NPC. The data supports further clinical development of oral seliciclib in NPC.

 

"We are pleased with these results, which met the conditions specified in the study protocol for proceeding to the next stage," said Judy Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We are grateful for the contributions of our investigators, their colleagues and patients who helped us complete the lead-in stage of this study. Although NPC is considered sensitive to radiation and chemotherapy treatments, once the disease recurs after initial chemotherapy and/or radiotherapy, the prognosis is poor despite the use of salvage chemotherapies. An unmet medical need exists for patients with recurrent and/or metastatic NPC. The results suggest that seliciclib induces prolonged stable disease and inhibits tumor growth in such patients and should be evaluated in randomized studies as a single agent and in combinations with other anti-cancer agents."

 

Best response by investigator assessment was:

 

 -- 7 out of 10 NPC patients achieved stable disease (SD) including
    3 with SD lasting longer than 8 months;

 

 -- 4 patients with other cancers (malignant histiocytoma, non-small
    cell lung, ovarian leiomyosarcoma and renal carcinomas) also
    achieved SD.

 

Phase 2 Study Details

 

Twenty-three patients were randomized to one of two dosing schedules of seliciclib (400 mg twice a day and 800 mg once a day both for 4 consecutive days every week for 3 weekly cycles), of which 13 had solid tumors and 10 previously-treated NPC. Twenty-one patients have received prior systemic therapies including 7 who had four or more prior systemic therapies.

 

The data demonstrated that seliciclib could be safely administered by the oral route on two dosing schedules both for 4 days per week. Both dosing schedules were well tolerated and met the criteria for proceeding to the randomized stage of the study. The most common grade 3 or 4 adverse events were anemia, increase in ALT enzymes and hypokalemia in two patients each. Seliciclib treatment resulted in prolonged stable disease in previously-treated NPC patients suggesting seliciclib inhibits tumor growth in NPC. The data supports further clinical development of oral seliciclib in NPC as a single agent or in combination with other anti-cancer agents. The results of the trial will be submitted for publication in a peer-reviewed journal.

 

Study Reference

 

W. Yeo, et. al., "A phase II randomized study of oral seliciclib in patients with previously treated nasopharyngeal carcinoma", J Clin Oncol 27:15s, 2009 (suppl; abstr 6026).

 

Conference call and Webcast Information:

 

Cyclacel management will review the NPC data and discuss the progress of its pipeline on a conference call scheduled for Wednesday June 3rd at 4:30 p.m. Eastern. Conference call and webcast details are as follows:

 

U.S./Canada call: (877) 493-9121/ international call: (973) 582-2750 U.S./Canada archive: (800) 642-1687 / international archive: (706) 645-9291 Code for live and archived conference call is 12669776

 

Webcast: For the live and archived webcast, please visit the CorporatePresentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

 

About Seliciclib

 

Seliciclib is an orally available cyclin dependent kinase (CDK) inhibitor that selectively inhibits multiple enzyme targets (CDK2/E, CDK2/A, CDK7 and CDK9), that are central to the process of cell division and cell cycle control. Seliciclib has been administered to approximately 400 patients to date and is currently being evaluated in a Phase 2b randomized, double blinded study ("APPRAISE") as a single agent treatment in patients with non-small cell lung cancer (NSCLC) treated with at least two prior systemic therapies. It is also being evaluated in a randomized, Phase 2 clinical trial in patients with nasopharyngeal cancer (NPC), a disease associated with Epstein-Barr virus infection.

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Bausch & Lomb Tampa manufacturing new FDA-approved medication

Bausch & Lomb's Tampa facility is manufacturing a new treatment for bacterial conjunctivitis, the condition commonly known as pink eye.

 

The company said Friday that the topical medication, called Besivance, has been approved by the U.S. Food and Drug Administration.

 

Bausch & Lomb (NYSE: BOL) purchased the original compounds of the medication in 2004 and has handled clinical testing since then, said Mike McDougall, VP of corporate communications and public affairs at Bausch & Lomb. Research and development has taken place both in Tampa and at the company's headquarters in Rochester, N.Y.

 

An FDA Advisory Committee voted unanimously to recommend approval of Besivance in December 2008. The approval follows a series of eight clinical trials, a release said.

 

Besivance will be part of a co-promotional deal between Bausch & Lomb and Pfizer Inc. (NYSE: PFE), McDougall said. It is expected to be available at pharmacies by prescription in June.

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Celldex Therapeutics to Acquire CuraGen

Celldex Therapeutics, Inc. today announced it has entered into a definitive agreement to acquire CuraGen Corporation (Nasdaq: CRGN - News). The acquisition will add a portfolio of oncology-focused, fully-owned antibodies to Celldex's Precision Targeted Immunotherapy Platform. Celldex will acquire CuraGen in a tax-free stock-for-stock transaction, which values CuraGen at approximately $94.5 million, subject to certain adjustments described within the definitive agreement. In addition to its pipeline, CuraGen is expected to have a cash balance of at least $54.5 million net of certain acquisition-related costs and CuraGen convertible debt at the transaction's close, which is anticipated to occur in the third quarter of 2009. Concurrent with the closing of the transaction, Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen, will join the Celldex Board of Directors.

 

Anthony Marucci, President and Chief Executive Officer of Celldex, stated, "The CuraGen acquisition fulfills a major initiative to identify, acquire and integrate value-creating, synergistic assets to fuel our Precision Targeted Immunotherapy Platform and enhance Celldex's antibody-based technology pipeline. In addition, this acquisition further strengthens Celldex's intellectual property estate and balance sheet, providing cash resources to advance our clinical development programs into 2012. Further, on behalf of the Celldex board and management team, I'd like to welcome Tim to our Board of Directors. We believe this transaction represents a combination that clearly exceeds the sum of its parts."

 

Timothy Shannon, M.D., President and Chief Executive Officer of CuraGen, commented, "CuraGen's Board of Directors considered a range of strategic alternatives to increase shareholder value and concluded that this transaction represents the best opportunity for our shareholders. We believe Celldex's immunotherapy expertise and platform technology provide an excellent fit for our antibody portfolio, industry collaborations, technological assets and intellectual property. The deal also offers CuraGen investors reduced risk via ownership of a broader portfolio, while still retaining upside potential of CR011 in the combined company."

 

CuraGen Corporation has a portfolio of 11 fully-owned, human antibodies that the Company selected, optimized and advanced during its collaboration with Abgenix (acquired by Amgen). CR011, currently in Phase 2 studies, is an antibody-drug conjugate that targets GPNMB, a protein that is highly expressed in metastatic breast cancer and melanoma. CR011 has shown promising early evidence of anti-tumor activity, including objective tumor responses, in patients with breast cancer and unresectable stage III and IV melanoma.

 

"Celldex's expertise in developing novel antibody-based therapeutics will enable us to seamlessly integrate CuraGen's antibody programs into our Precision Targeted Immunotherapy Platform and selectively identify and advance the candidates we believe hold the most therapeutic promise," said Thomas Davis, M.D., Chief Medical Officer of Celldex.

 

Celldex Therapeutics is discovering and developing innovative targeted immunotherapeutics for the treatment of cancer, infectious and inflammatory diseases. The Company's focus is on the use of tumor-specific targets and human monoclonal antibodies to precisely deliver therapeutic agents through their novel targeted immunization approach. Celldex's deep pipeline consists of product candidates in varying stages of development, with lead candidate CDX-110, partnered with Pfizer, currently undergoing evaluation in a Phase 2 clinical trial in newly diagnosed glioblastoma multiforme (GBM) and CDX-1307, currently enrolling in a Phase 1 study in epithelial tumors. In addition, the Company recently completed the successful preclinical development of CDX-1401, a candidate for study in multiple solid tumors.

 

The acquisition of CuraGen adds to Celldex's clinical development program a number of important milestones anticipated over the next 12 to 18 months including:

 

    * Present data at ASCO in June of 2009

 

          o Phase 2 CDX-110 ACT II and ACTIVATE data in GBM
          o Phase 2 CR011 breast cancer and melanoma data
          o Phase 1 CDX-1307 combination data in epithelial cancers
    * Continue development of and/or enrollment in core clinical programs

 

          o Phase 2 ACT III study of CDX-110 in GBM; design of randomized study in GBM
          o Phase 2 CR011 studies in breast cancer and melanoma; determine next steps for CR011 development in breast cancer and melanoma
          o Phase 1 CDX-1307 novel combination therapy study in epithelial cancers
    * Initiate new clinical studies

 

          o Phase 2 CDX-1307 randomized study in bladder cancer
          o Phase 1/2 CDX-1401 study in multiple solid tumors
    * File at least one IND resulting from recent business development and licensing activities
    * Drive internal research to fuel an exciting pipeline of opportunities for future years

 

Transaction Terms

 

Under the terms of the definitive agreement, Celldex will acquire CuraGen in a tax-free stock-for-stock transaction, representing an equity value of approximately $94.5 million. The purchase price payable in this transaction is subject to certain adjustments described within the definitive agreement, including a collar of between 32.5% and 58% of Celldex's outstanding common stock. The transaction, which is subject to the receipt of CuraGen and Celldex stockholder approvals and other customary closing conditions, is expected to be completed in the third quarter of 2009.

 

CuraGen is expected to deliver $68.6 million in cash, net of acquisition-related costs, including transaction fees and severance payments and a closing balance sheet adjustment. At the close of the transaction, Celldex will assume $14.1 million of CuraGen's 4% convertible debt due in February 2011, resulting in an expected $54.5 million of net cash. The Boards of Directors of each of Celldex and CuraGen have approved the transaction and unanimously recommended that their stockholders approve the transaction.

 

Celldex was advised by WBB Securities, LLC, Brean Murray, Carret & Co., LLC and Lowenstein Sandler PC. CuraGen was advised by Piper Jaffray & Co. and Wilmer Cutler Pickering Hale and Dorr LLP.

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Article on Malaria Vaccine Tested in African Clinical Trial

Researchers have begun a major clinical trial in Africa of what could become the world's first vaccine against malaria, a disease that kills nearly a million people every year.

 

The vaccine's developers -- drug giant GlaxoSmithKline PLC and the Path Malaria Vaccine Initiative, or MVI, a charitable group funded by the Bill & Melinda Gates Foundation -- began a study in 16,000 African children this week, the largest-ever trial of the potential inoculation.

 

The study is part of a broader effort by the Gates Foundation, together with Glaxo and other drug companies, to develop vaccines and drugs that aren't commercially attractive but would help combat diseases that afflict poor regions such as sub-Saharan Africa. The malaria vaccine, which has performed well in smaller trials, could be available by 2013 if the larger trial goes well.

 

The latest study will include two age groups: infants and children five to 17 months old. Half of each group will get the vaccine and half a placebo. All will be given bed nets to protect against mosquitoes, which carry the disease. Then they will be followed over two years for signs of clinical malaria. The study is taking place in seven African countries, with the first shots happening this week in Tanzania.

 

Glaxo researchers in Belgium began working on the vaccine in the late 1980s. Over the past decade, MVI, through a grant from the Gates Foundation, has financed a series of smaller trials of the vaccine, which is the most advanced of any for malaria. In one study that ended last year in 809 African children, the vaccine reduced the children's risk of developing clinical malaria by 50% compared with a placebo.

 

Christian Loucq, director of MVI, said that if the shot shows the same efficacy in the larger trial, it would "definitely save hundreds of thousands of lives" each year.

 

The best way to prevent malaria today is through bed nets and insecticides that keep mosquitoes at bay. Drugs to treat malaria also exist, but they are in short supply in some countries. The parasite that causes malaria can also develop resistance to these drugs, as has happened recently along the Thai-Cambodian border, causing concern among health experts.

 

If the vaccine makes it to market, Glaxo will produce it at a factory in Belgium. Jean Stephenne, head of Glaxo's vaccine business, said in a telephone interview that donor groups such as the Global Alliance for Vaccines and Immunization will probably be the ones to buy the vaccine for developing countries.

 

Mr. Stephenne said Glaxo will ensure that price is not a "barrier to access," but he said it was too early to comment on exact pricing. A Glaxo spokeswoman said the company will seek to cover its cost of production. "The last thing we expect to do is make a profit in endemic malarial areas," she said.

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Vanda Pharmaceuticals Announces Date of Annual Meeting of Stockholders

Vanda Pharmaceuticals Inc. announced today that it will hold its 2009 Annual Meeting of Stockholders on Thursday, August 27, 2009, in Rockville, Maryland. The record date for the Annual Meeting will be June 29, 2009. Only stockholders of record at the close of business on June 29, 2009 may vote at the meeting or any adjournment thereof. Vanda anticipates mailing its proxy statement in July 2009 to its stockholders of record, which proxy statement will include the time and location of the Annual Meeting, as well as a description of the matters to be considered.

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FDA Newsletter - Holds on Clinical Trials Lifted in India, the US

The Drugs Controller General of India (DCGI) has lifted a suspension it imposed on clinical trials of Wyeth's pneumonia vaccine Prevnar 13, and the FDA has ended clinical holds on Stem Cell Therapeutics' stroke treatment and on Nile Therapeutics' CD-NP treatment for acute heart failure and renal insufficiency. India will allow Phase III trials of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) to resume at 11 sites, Douglas Petkus, a spokesman for Wyeth, said.

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Cytokinetics To Present Phase IIa Clinical Trials Data On CK-1827452 At The 2009 Heart Failure Congress Of The European Society Of Cardiology

Cytokinetics, Incorporated announced that data relating to two Phase IIa clinical trials evaluating CK-1827452, one in stable heart failure patients and one in patients with ischemic cardiomyopathy and angina, are scheduled to be presented in two poster presentations and in the late breaking trials session at the 2009 Heart Failure Congress of the European Society of Cardiology, to be held May 30-June 2, 2009, at the Nice Acropolis Palais des Congrès et Expositions in Nice, France.

 

Late Breaking Trials Session

 

The late breaking presentation titled "The Selective Cardiac Myosin Activator, CK-1827452, Increases Systolic Function in Heart Failure" will be presented on Monday, June 1, 2009 from 11:00 AM - 12:30 PM Central European Time in the Apollon Auditorium by John Cleland, MD, FACC, FRCP, FESC, Professor of Cardiology, Castle Hill Hospital, University of Hull, United Kingdom.

 

Poster Presentations

 

Program #149: "Echocardiographic Detection of Increases in Ejection Fraction in Patients with Heart Failure Receiving the Selective Cardiac Myosin Activator, CK-1827452″ is scheduled to be displayed in the session titled "Medical and Surgical Treatments Poster Session: Drug Therapy, Other" on Sunday, May 31, 2009 from 8:30 AM - 12:30 PM Central European Time in the Clinical Poster Zone. The poster will be moderated by Jonathan H. Goldman, MD, FACC, Chief Medical Officer, ICON Medical Imaging, Warrington, PA from 10:00 AM - 11:00 AM.

 

Program #174: "Phase II Safety Study Evaluating the Novel Cardiac Myosin Activator, CK-1827452, in Patients with Ischemic Cardiomyopathy and Angina" is scheduled to be displayed in the session titled "Medical and Surgical Treatments Poster Session: Drug Therapy, Other" on Sunday, May 31, 2009 from 8:30 AM - 12:30 PM Central European Time in the Clinical Poster Zone. The poster will be moderated by Barry H. Greenberg, MD, Chair of the Safety Review Committee for this clinical trial and Director, Advanced Heart Failure Treatment Program, University of California, San Diego Medical Center from 10:00 AM - 11:00 AM.

 

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NEJM study finds drug-eluting stents more effective than bare-metal stents in heart attack patients

Landmark Horizons-AMI study led by NewYork-Presbyterian Hospital and Columbia University Medical Center in collaboration with the Cardiovascular Research Foundation

 

NewYork-Presbyterian Hospital and Columbia University Medical Center, together with the Cardiovascular Research Foundation (CRF), announced that its landmark study comparing the safety and efficacy of drug-eluting stents and bare-metal stents was published in the May 7 New England Journal of Medicine. The study, HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction), showed that in heart attack patients undergoing angioplasty, the use of paclitaxel-eluting stents reduces rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of bare-metal stents after one year.

 

Additionally, the primary safety measure of major adverse cardiovascular events (MACE), including death, reinfarction, stent thrombosis and stroke established the non-inferiority of drug-eluting stents with respect to safety through one year.

 

The study was led by Dr. Gregg W. Stone, director of cardiovascular research and education in the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center; and professor of medicine at Columbia University College of Physicians and Surgeons. The research was sponsored and managed by the Cardiovascular Research Foundation with research grant support from Boston Scientific Corporation and The Medicines Company.

 

In the trial, the use of paclitaxel-eluting stents resulted in a significant reduction of ischemia-driven target-lesion revascularization (TLR) at 12 months (4.5% vs. 7.5%). TLR, which was the primary efficacy endpoint of the trial, refers to the rate at which a particular lesion re-narrows following stent implantation severely enough to require either a repeat angioplasty or bypass surgery operation.

 

The use of paclitaxel-eluting stents also resulted in a significant reduction in binary restenosis after 13 months, which is the rate at which the artery re-narrows at least 50 percent following implantation of the stent, and was the secondary efficacy endpoint of the trial. The paclitaxel-eluting stent had a rate of 10.0 percent and the bare-metal stent had a rate of 22.9 percent.

 

"Outcomes from prior registry and randomized trials of drug-eluting stents compared with bare-metal stents in heart attack patients have been conflicting. These results now provide definitive evidence that paclitaxel-eluting stents are superior in efficacy to bare-metal stents and have a comparable safety profile at one year," says Dr. Stone. "The findings from the HORIZONS-AMI trial will have a major impact on how decisions are made regarding drug-eluting and bare-metal stents in the highest-risk patients, those in the early hours of a heart attack. This study removes much of the uncertainty and concern about the efficacy and safety of drug-eluting stents in this clinical setting. Moreover, all of the patients in this trial will be followed long-term to ensure that these favorable results are maintained."

 

The HORIZONS-AMI trial, a prospective, open-label, multicenter, controlled study, enrolled 3,602 heart attack patients at 123 centers in 11 countries, 3,006 of whom were randomized to paclitaxel-eluting stents versus otherwise identical bare-metal stents.

 

Co-authors include Drs. Alexandra J. Lansky, George Dangas and Roxana Mehran, Ms. Alison Kellock and Ms. Helen Parise of NewYork-Presbyterian/Columbia; Dr. S. Chiu Wong of NewYork-Presbyterian Hospital/Weill Cornell Medical Center; Dr. Stuart J. Pocock of the London School of Hygiene and Tropical Medicine, London; Dr. Bernard J. Gersh of Mayo Clinic, Rochester, Minn.; Dr. Bernhard Witzenbichler of Charité Campus Benjamin Franklin, Berlin; Dr. Martin Möckel of Charité Campus Virchow-Klinikum, Berlin; Dr. Giulio Guagliumi of Ospedali Riuniti di Bergamo, Bergamo, Italy; Dr. Jan Z. Peruga of Medical University, Lodz, Poland; Dr. Dariusz Dudek of Jagiellonian University, Krakow; Dr. Andrzej Ochala of the Silesian Medical Academy, Katowice, Poland; Dr. Bruce R. Brodie of LeBauer Cardiovascular Research Foundation and Moses Cone Hospital, Greensboro, N.C.

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Green tea extract shows promise in leukemia trials

Mayo Clinic researchers are reporting positive results in early leukemia clinical trials using the chemical epigallocatechin gallate (EGCG), an active ingredient in green tea. The trial determined that patients with chronic lymphocytic leukemia (CLL) can tolerate the chemical fairly well when high doses are administered in capsule form and that lymphocyte count was reduced in one-third of participants. The findings appear today online in the Journal of Clinical Oncology.

 

"We found not only that patients tolerated the green tea extract at very high doses, but that many of them saw regression to some degree of their chronic lymphocytic leukemia," says Tait Shanafelt, M.D., Mayo Clinic hematologist and lead author of the study. "The majority of individuals who entered the study with enlarged lymph nodes saw a 50 percent or greater decline in their lymph node size."

 

CLL is the most common subtype of leukemia in the United States. Currently it has no cure. Blood tests have enabled early diagnosis in many instances; however, treatment consists of watchful waiting until the disease progresses. Statistics show that about half of patients with early stage diseases have an aggressive form of CLL that leads to early death. Researchers hope that EGCG can stabilize CLL for early stage patients or perhaps improve the effectiveness of treatment when combined with other therapies.

 

The research has moved to the second phase of clinical testing in a follow-up trial -- already fully enrolled -- involving roughly the same number of patients. All will receive the highest dose administered from the previous trial.

 

These clinical studies are the latest steps in a multiyear bench-to-bedside project that began with tests of the green tea extract on cancer cells in the laboratory of Mayo hematologist Neil Kay, M.D., a co-author on this article. After laboratory research showed dramatic effectiveness in killing leukemia cells, the findings were applied to studies on animal tissues and then on human cells in the lab. (See "Green Tea and Leukemia" in Discovery's Edge magazine.)

 

In the first clinical trial, 33 patients received variations of eight different oral doses of Polyphenon E, a proprietary compound whose primary active ingredient is EGCG. Doses ranged from 400 milligrams (mg) to 2,000 mg administered twice a day. Researchers determined that they had not reached a maximum tolerated dose, even at 2,000 mg twice per day.

 

VIDEO ALERT: Additional audio and video resources, including comments by Dr. Shanafelt describing the research, are available on the Mayo Clinic News Blog. These materials are also subject to embargo but may be accessed in advance by journalists for incorporation into stories. The password for this post is gteacll.

 

The study was sponsored by Mayo Clinic, the CLL Global Research Foundation, CLL Topics (including contributions by individual CLL patients) and the Commonwealth Foundation for Cancer Research. Medication for the study was provided by Polyphenon E International. Others on the research team were Timothy Call, M.D.; Clive Zent, M.D.; Betsy LaPlant; Deborah Bowen; Michelle Roos; Charla Secreto; Asish Ghosh, Ph.D.; Brian Kabat; Diane Jelinek, Ph.D.; and Charles Erlichman, M.D., all of Mayo Clinic; and Mao-Jung Lee, Ph.D., and Chung Yang, Ph.D., both of Rutgers University.

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Cougar's prostate drug sees 70 pct response in trials

 * Up to 70 pct of men in Phase I/II responded to abiraterone

 

* BTG set to earn royalties from the drug

 

* Seen as a major development for prostate cancer

 

 

Cougar Biotechnology's (CGRB.O) prostate cancer drug abiraterone has produced "significant benefits" in about two thirds of men, the results of phase I/II trials have shown.

 

The Los Angeles-based cancer specialist has released its first full peer-reviewed phase II results, which, in combination with previously released phase I data, show that up to 70 percent of men responded to the drug.

 

The data, published on Tuesday in the online version of the Journal of Clinical Oncology, show that about two-thirds of men experienced "significant benefits" for an average of eight months, with scans showing their tumours decreased in size.

 

Johann de Bono, chief investigator of the study, which was undertaken by the British Institute of Cancer Research and the Royal Marsden Hospital, called the results "brilliant".

 

"The patients involved in this trial remained pain-free for an average of about eight months, a brilliant result for those with aggressive prostate cancer and their families.

 

"For about a third of men -- those who carried the ERG gene -- the benefit lasted for more than 18 months."

 

The drug was licensed from British biotechnology company BTG (BGC.L) in April 2004.

 

Analysts at Piper Jaffray estimate $1 billion sales in 2015 and net 3 percent royalty to BTG.

 

Last week, U.S. company Johnson & Johnson (JNJ.N) announced that it has agreed to acquire Cougar for about $970 million in cash in order to strengthen its oncology business. [ID:nN21310649] (Editing by Rupert Winchester)

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Kraig Biocraft Laboratories, Inc. News Release

Kraig Biocraft Laboratories, Inc. Gears Up to Double the Number of Genetic Insertions Performed and Amgen Exercises Option for Exclusive License to Cytokinetics' Cardiac Contractility Program That Includes CK-1827452.

 

Biotechnology industry news provided by Financial News USA. Kraig Biocraft Laboratories, Inc. (OTCBB: KBLB) announce that the scientific team is preparing to significantly ramp up the number of genetic insertions performed in the month of May. The team anticipates that the rate of DNA construct insertions in May will be double that which has been performed to date. ``We are now entering the next phase in which the team is reallocating recourses to genetic insertion,'' said CEO Kim Thompson. ``This is directly related to our recent development of new DNA constructs that are specifically targeted for the production of new fusion silk proteins. We intend to dramatically ramp up the number of insertions performed in order to gain the maximum benefit from the new insertion packets.''
Cytokinetics Incorporated (Nasdaq: CYTK) and Amgen Inc. (NasdaS: AMGN) today announced that Amgen has exercised its option to obtain an exclusive license, worldwide (excluding Japan), to Cytokinetics' cardiac contractility program. The license includes CK-1827452, a novel cardiac myosin activator being developed for the treatment of heart failure.

 

XOMA Ltd. (Nasdaq: XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the following presentations related to its XOMA 052 anti-interleukin-1 (IL-1) beta antibody will take place at the American Diabetes Association 69th Scientific Sessions, to be held at the Morial Convention Center in New Orleans, Louisiana from June 5 to 9.

 

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS), a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics, today announced that updated interim data from the Company's ongoing Phase 2 clinical trials in frontline acute myeloid leukemia (AML) and platinum-resistant ovarian cancer and its Phase 1b/2 clinical trial in relapsed/refractory AML will be presented during the American Society of Clinical Oncology (ASCO) 2009 Annual Meeting in Orlando, Florida, which begins May 29, 2009. Following are the details on each of these data presentations.

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Cornerstone Pharmaceuticals Initiates Phase I/II Combination Therapy Clinical Trial of CPI-613 For Treatment of Pancreatic Cancer

 First-in-class Alerted Energy Metabolism Directed ("AEMD") Compound Targets Metabolic Changes Found In Multiple Tumor Types

 

Cranbury, NJ (PRWEB) May 27, 2009 -- Cornerstone Pharmaceuticals, Inc., a privately-held pharmaceutical company, announced today that it has begun a phase I/II clinical trial of CPI-613, the initial candidate to emerge from the company's Altered Energy Metabolism Directed technology platform. The drug will be used in combination with gemcitabine, a standard chemotherapeutic for the treatment of pancreatic and other cancers. Patients newly diagnosed and intended to be treated with gemcitabine may be eligible for this study. This positions CPI-613 for potential "front line" use.

 

CPI-613 is the first drug in a new chemical class that, through a novel mechanism, targets metabolic changes that may be common to many cancer types. CPI-613 has been granted orphan drug status by the US FDA for pancreatic cancer, a cancer type that typically has a poor prognosis, spreads rapidly and often goes undetected in its early stages.

 

The initiation of these trials represents a significant advance in Cornerstone's continued quest to develop innovative treatments for patients suffering from this devastating disease and other cancer types

 

Pancreatic cancer is one of the most challenging cancers to treat, due in part to a dearth of available drugs. We are very excited by this groundbreaking technology's potential as an efficacious treatment

 

It is projected that this year there will be more than 42,000 Americans diagnosed with pancreatic cancer and approximately 35,000 deaths associated with pancreatic cancer.

 

"The initiation of these trials represents a significant advance in Cornerstone's continued quest to develop innovative treatments for patients suffering from this devastating disease and other cancer types," remarked Dr. Robert Shorr, Ph.D. D.I.C., Chief Executive Officer for Cornerstone Pharmaceuticals.

 

"Pancreatic cancer is one of the most challenging cancers to treat, due in part to a dearth of available drugs. We are very excited by this groundbreaking technology's potential as an efficacious treatment," commented Avi Retter M.D., an Oncologist with Eastchester Center for Cancer Care.

 

The open-label trial is currently underway at the Eastchester Center for Cancer Care in New York for patients who have not previously received CPI-613 or gemcitabine. Additional clinical sites will be added.

 

The combination therapy study marks Cornerstone Pharmaceuticals' second drug trial. The first, a safety and early efficacy trial of CPI-613 to evaluate its potential use in a wide array of cancers, commenced dosing patients in September 2008 for patients who had failed current therapies. In addition to these trials, the company is exploring specific changes that occur in tumors that may predict outcome and allow for a more personalized approach for cancer treatment.

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New osteoarthritis drug 'improves quality of life'

A new derivative of the non-steroidal anti-inflammatory drug naproxen has been found to improve quality of life for knee osteoarthritis (OA) patients in a Phase III clinical trial.

 

Naproxcinod was tested on more than 900 patients with knee OA and was assessed by researchers at pharmaceutical company NicOx for its effects on quality of life and utility.

 

Patients were divided into four groups and were given doses of either 375mg or 750mg of naproxcinod twice a day. The other two groups took 500mg of naproxen or a placebo twice daily.

 

The Nicox researchers followed the study participants for 13 weeks and found that all four groups showed improvements in quality of life.

 

Patients taking naproxcinod or naproxen exhibited significantly better outcomes that those taking the placebo, while study participants on the higher dose of naproxcinod showed better results than those on lower doses of the drug and patients on naproxen.

 

Pascal Pfister, chief scientific officer and head of R&D at NicOx, revealed the results of the trial to an audience at the annual meeting of the Society For Pharmacoeconomics and Outcomes Research in the US.

 

"The positive differences seen with the higher dose of naproxcinod, compared to the standard dose of naproxen, may be explained by a different side-effect profile and its neutral blood pressure effect," he explained.

 

"We look forward to presenting the utility and quality of life data from the full phase III programme before the end of 2009."

 

Knee OA is a common form of osteoarthritis that occurs when the cartilage connecting the thigh bone to the shin bone weakens and thins, causing the bones to rub against each other. This leads to patients experiencing pain, stiffness and inflammation.

 

A spokeswoman for the Arthritis Research Campaign commented that new treatments for osteoarthritis were desperately needed without the safety concerns associated with current non-steroidal anti-inflammatory drugs (NSAIDs).

 

"Any new NSAID coming on to the market has to demonstrate safety as well as efficacy," she added.

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Ceregene Presents Additional Clinical Data from Phase 2 Trial of CERE-120 for Parkinsons Disease

Ceregene, Inc. today reported additional clinical data from a double-blind, controlled Phase 2 trial of CERE-120 in 58 patients with advanced Parkinson's disease. CERE-120 uses AAV-based gene therapy to deliver the neurotrophic factor, neurturin, to Parkinson's disease patients in order to restore the function and protect degenerating nigrostriatal neurons. The company previously announced that the Phase 2 trial did not meet its primary endpoint of improvement in the Unified Parkinson's Disease Rating Scale (UPDRS) motor off score at 12 months of follow-up, although several secondary endpoints suggested a modest clinical benefit.

 

The additional, protocol-prescribed analyses reported today focused on further analyses of the data from the 30 subjects who continued to be evaluated under double-blind conditions for up to 18 months which indicate increasing effects of CERE-120 over time. A clinically modest but statistically significant treatment effect in the primary efficacy measure (UPDRS motor off; p=0.025), as well as similar effects on several more secondary motor measures (p<0.05), were seen at the 18 month endpoint. Not a single measure similarly favored sham surgery at either the 12 month or 18 month time points. Additionally, CERE-120 appears safe when administered to advanced Parkinson's disease patients, with no significant concerns related to the neurosurgical procedure, the gene therapy vector, or the expression of neurturin in the Parkinson's disease brain.

 

The company also reported the results of analyses of neurturin gene expression in the brains from two CERE-120 treated subjects who died of causes unrelated to treatment. These analyses revealed that CERE-120 produced clear evidence of neurturin expression in the targeted putamen but no evidence for transport of this protein to the cell bodies of the degenerating neurons, located in the substantia nigra. In addition to the known cell loss in Parkinson's disease, these findings suggest that deficient axonal transport in degenerating nigrostriatal neurons in advanced Parkinson's disease impaired transport of CERE-120 and/or neurturin from putaminal terminals to nigral cell bodies, reducing the bioactivity of CERE-120. The data were presented today at the American Society of Gene Therapy Meeting in San Diego, CA by Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer.

 

"While we were disappointed that our initial analysis of the data from this trial did not demonstrate a benefit of CERE-120 in the primary endpoint at 12 months, we are greatly encouraged by both the results of these protocol-prescribed analyses in patients who remained blinded for up to 18 months, as well as by the insight we gained," stated Dr. Bartus. "Collectively, these data suggest that CERE-120 is indeed exerting a unique and potentially important biological effect on the degenerating dopamine neurons in moderately advanced Parkinson's disease patients but that the inability of these neurons to efficiently transport neurturin back to their cell bodies compromises and delays the neurotrophic effects of neurturin in a manner that had not been anticipated. Importantly, we believe that we can overcome the transport problems of these degenerating neurons by modifying the dosing paradigm to also directly target their cell bodies in the substantia nigra with CERE-120."

 

"We remain optimistic that CERE-120 has the potential to significantly improve the treatment of advanced Parkinson's disease patients," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "The information gained from this initial controlled Phase 2 trial in advanced Parkinson's disease patients has been invaluable, and we can now incorporate these insights in a follow-on clinical trial that we are planning to initiate later this year. Our goal remains to significantly improve the symptoms of Parkinson's patients and also to provide the opportunity to delay further disease progression."

 

About Phase 2 Trial of CERE-120

 

Ceregene's Phase 2 trial was a double-blind, controlled clinical trial that completed enrollment of 58 patients with advanced Parkinson's disease in October 2007. This study was launched after successful execution of an extensive nonclinical program and preliminary evidence of safety and efficacy in advanced Parkinson's patients via an open-label Phase 1 trial in 12 patients. Patients in the Phase 2 trial were enrolled across nine leading academic medical centers in the United States, with two thirds of patients receiving CERE-120 and one third enrolled into a control group. Patients received a single administration of CERE-120 via stereotactic neurosurgery to deliver the drug into the putamen region of the brain and were followed for a minimum of 12 months for safety and efficacy, with over half the subjects followed for 15 to 18 months under blinded conditions, allowing longer-term analyses of the therapeutic effects of CERE-120. Ceregene gratefully acknowledges the financial support received from the Michael J. Fox Foundation for Parkinson's Research to help defray some of the costs of the CERE-120 Phase 1 and Phase 2 clinical trials.

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Cottonseed-based drug shows promise in treating severe brain cancer

BIRMNGHAM, Ala. ? An experimental drug derived from cottonseed shows promise in treating the recurrence of glioblastoma multiforme, widely considered the most lethal brain cancer, said researchers at the University of Alabama at Birmingham (UAB).

 

The new results are from a Phase II clinical trial of AT-101, a pill manufactured from a potent compound in cottonseed that overcomes the abnormal growth patterns of tumor cells. This cottonseed-based agent must be properly dosed and monitored by physicians.

 

In clinical tests, AT-101 halted the cancer's progression in many of the 56 patients, said John Fiveash, M.D., an associate professor in the UAB Department of Radiation Oncology and the lead researcher on the new study.

 

Despite undergoing other treatments, including surgery, chemotherapy and radiation, the trial patients' brain cancer had begun to grow again prior to starting AT-101 treatments. The trial-monitored patients took only AT-101 daily for three out of four weeks. Glioblastomas are more common in adults and are considered fast-growing brain tumors that are very difficult to treat, Fiveash said.

 

"After getting this drug some of these patients went many months without any new growth in their tumors," Fiveash said. "We are able to do that with a well-tolerated oral medication, and that is a major benefit." His initial results will be presented May 30 during the poster discussion of central nervous system tumors at the American Society for Clinical Oncology annual meeting in Orlando, Fla.

 

Fiveash said the drug would likely work best in combination with radiation and chemotherapy to boost the cancer-fighting properties of those treatments. Also, investigators are trying to learn which patients are most likely to benefit from AT-101.

 

The AT-101 trial is a partnership that includes Fiveash, the UAB Comprehensive Cancer Center, Massachusetts General Hospital in Boston, Johns Hopkins University in Baltimore, The Cleveland Clinic in Ohio, Henry Ford Hospital in Detroit, Emory University in Atlanta, Moffit Cancer Center in Tampa, the University of Pennsylvania in Philadelphia, Wake Forest University in Winston-Salem, N.C., and the National Cancer Institute's Cancer Therapeutics Evaluation Program.

 

AT 101 is manufactured by Ascenta Therapeutics Inc. based in Malvern, Penn. Multiple preclinical and clinical trials with AT-101 are ongoing in several tumor types, including prostate, lung, B-cell malignancies and other forms of cancer.

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The OSMOS Advantage for Clinical Trials in Emerging Markets

OSMOS Clinical Research is a premier consultancy firm that advises pharmaceutical, biotechnology and medical device companies in conducting clinical trials in emerging markets with a focus on Eastern Europe, Latin America and India.

 

OSMOS offers its clients unparalleled advantages when conducting clinical trials in foreign countries. OSMOS works to provide crucial information necessary to determine and retain the best and most cost-effective locations and vendors for their projects, all while negotiating terms, streamlining budgets and managing study teams. OSMOS helps to avoid potential costly pitfalls by bringing on board local expertise - guiding its clients through the clinical trial process from feasibility to completion.

 

OSMOS also ensures that its clients stay in control of projects via expert oversight, co-monitoring, and GCP auditing. This close assistance and guidance provides clients peace of mind that clinical trials will be compliant with all relevant regulations and that data will be verifiable and reliable.

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BioCis Pharma Starts a Phase I Clinical Trial With a New Cancer Drug

BioCis Pharma Ltd., a privately-held drug development company with its headquarters in Turku, Finland, has started Phase I clinical testing of ProtoCure(TM) intravesical instillation solution, a novel anti-cancer drug for urinary bladder cancer. ProtoCure is based on a new mechanism of action discovered and developed by BioCis Pharma which effectively prevents cancer growth and proliferation locally.

 

The open-label, dose-escalating study is designed to evaluate the safety, tolerability and pharmacokinetics of the locally administered (into the bladder) product in a total of 22 patients with primary or recurrent non-muscle invasive bladder cancer and it is expected to be well tolerated.

 

"We are pleased to advance to clinical testing with the ProtoCure instillation solution," says Lasse Leino, CEO of BioCis Pharma. "It is our first oncology product to reach this important milestone and follows the initiation of two phase 2a studies with our leading anti-inflammatory product in patients with inflammatory skin disorders that we recently announced. The ProtoCure cancer drug holds great promise for patients suffering from superficial bladder cancer. We are committed to take the product quickly to more extensive clinical efficacy testing after this preliminary safety study. We expect to get results from this study by the first quarter of 2010."

 

Bladder cancer is the fourth most common cancer in men and tenth among women. In addition, the recurrence rate is high, being almost 70 % in patients with the non-invasive form of the cancer, where the malignancy is typically found in the surface layers of the bladder. Non-invasive bladder cancer is treated by urologists using local surgery and intravesical drug therapy administered directly into the bladder. Existing drug therapies often have undesirable side effects and limited efficacy.

 

BioCis Pharma Ltd is an innovative drug development company developing drug therapies based on a novel, patented therapeutic principles that target unmet medical needs in substantial therapeutic markets including inflammation, allergy, and cancer. The company's main investors are Karolinska Development AB (publ.), Finnish Industry Investment Ltd., and Etra Invest Oy.

 

http://www.biocis.com

 

Contacts:

 

Dr. Lasse Leino, CEO, BioCis Pharma Ltd., mobile phone +358-40-849-4694

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Clinical Trial of Fosbretabulin in Anaplastic Cancer of the Thyroid (FACT)

If you or someone you know has anaplastic thyroid cancer, you'll want to learn more about the FACT clinical trial of the drug fosbretabulin, which is also known as Zybrestat.

 

The trial is recruiting patients with regionally-advanced or metastatic anaplastic thyroid cancer at sites in the United States, Eastern and Western Europe, Asia, and the Middle East.

 

You can find out more at the Clinical Trial: FACT - Fosbretabulin in Anaplastic Cancer of the Thyroid page, hosted by drugmaker Oxigene.

 

Also, full information on sites for the trial and how to enroll and participate is located at the National Institutes of Health Clinical Trials.gov page, Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer.

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MediciNova Announces Plan to Modify Its Phase II Placebo-Controlled Clinical Trial Evaluating MN-221 in Patients With Severe, Acute Exacerbations of Asthma

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today announced that it will modify the dosing regimen for the ongoing Phase II clinical trial (MN-221-CL-007), which is evaluating the safety and efficacy of MN-221 in patients with severe, acute exacerbations of asthma. Dosing in the MN-221-CL-007 clinical trial will now compare standardized care only to standardized care plus MN-221 at a dose of 250 micrograms administered over 15 minutes rather than at a dose of 1.2 mg administered over one hour, as previously planned under the study protocol. The modification is based on further analysis of data from the recently completed Phase II clinical trial (MN-221-CL-006) which evaluated MN-221 at planned escalating doses in patients with severe, acute exacerbations of asthma treated in emergency departments and two earlier Phase II clinical trials (MN-221-CL-004 and MN-221-CL-005) which evaluated MN-221 in patients with stable asthma. In particular, in the MN-221-CL-006 clinical trial, patients who received MN-221 at 240 micrograms over 15 minutes in combination with standard care demonstrated the best efficacy based on improvements in forced expiratory volume in 1 second (FEV1) and in hospitalization rate.

 

MediciNova has submitted an amendment to the clinical trial protocol for MN-221-CL-007 to the U.S. Food and Drug Administration (FDA) which reflects the modified dosing regimen and plans to submit the same information to the relevant regulatory authorities outside of the United States. MediciNova has communicated this modification to the participating study investigators and clinical sites and will wait to further enroll patients in this study pending review and approval of the amended clinical trial protocol by the relevant regulatory authorities. MediciNova anticipates patient enrollment to resume within approximately two months and expects to complete enrollment within nine to twelve months from such point in time.

 

"These clinical results from our three completed Phase II clinical trials support the potential efficacy of lower doses of MN-221 plus standard treatment in patients with acute exacerbations of asthma based on improvements in FEV1 and in rates of hospitalizations," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "We believe that testing a lower potentially effective dose will maximize the benefit of MN-221's safety profile and offer a more convenient 15 minute dosing regimen."

 

About the MN-221-CL-007 Phase II Clinical Trial

 

MN-221-CL-007 is a randomized, double-blind, placebo-controlled Phase II clinical trial. A total of approximately 35 clinical sites, including the clinical sites rolled-over from the MN-221-CL-006 clinical trial, in North America, Australia and New Zealand will enroll approximately 200 patients into the MN-221-CL-007 clinical trial. Once a patient has received the initial standardized care treatment regimen (consistent with the National Asthma Education and Prevention Program and the Global Initiative for Asthma (GINA) guidelines), the patient will be assessed for response to that treatment. If the patient's FEV1 is less than or equal to 50 percent of predicted and the patient meets all other study entry criteria, the patient will be randomized to receive either MN-221 or placebo. Patients enrolled in the study will continue to receive standardized care as needed while receiving an intravenous infusion of MN-221 or placebo. The primary efficacy endpoint will be improvement in FEV1.

 

About MN-221

 

MN-221 is a highly-selective Beta 2-adrenergic receptor agonist. Preclinical testing in vitro and in vivo shows MN-221 to be more selective for the Beta 2-adrenergic receptor than other Beta 2-adrenergic receptor agonists commonly used for these asthma attacks. This improved selectivity, coupled with its partial agonist activity at Beta 1-adrenergic receptors, may result in fewer cardiovascular side effects than are commonly observed with these other agents. MediciNova has developed an intravenous formulation of MN-221 that bypasses the constricted airways to deliver the drug to the lungs. In addition to the data described above, MN-221 has been shown to produce significant improvements in mean change in post-infusion (15 minute) FEV1 from baseline (objective measure of lung function) at doses of 3.5 micrograms/min (p=0.011), and at 10, 16, 30 and 60 micrograms/min (p less than or equal to 0.0001), compared to placebo in stable mild-to-moderate asthma patients (MN-221-CL-004). Administration of MN-221 at a dose of approximately 1.1 mg over intervals of 1 or 2 hours also produced marked improvement in FEV1 in patients with moderate-to-severe stable asthma (MN-221-CL-005). In addition, administration of 1.1 mg of MN-221 over 1 hour produced the greatest FEV1 improvement in patients with stable asthma of the regimens tested in these two studies. Based on an analysis of the data from the recently completed Phase II clinical trial (MN-221-CL-006), a dose of 240 micrograms (16 micrograms/minute for 15 minutes) of MN-221 to subjects with an acute exacerbation of asthma in combination with standard care was associated with marked improvement in FEV1 and reduction in hospitalization rate compared to standard care alone and was well tolerated. In addition, a drug interaction study in dogs found that adding MN-221 by intravenous administration in combination with inhaled albuterol does not add to the heart rate increase associated with inhaled albuterol alone.

 

MediciNova acquired an exclusive, worldwide (excluding Japan), sublicensable license to MN-221 from Kissei Pharmaceutical Co., Ltd. The intellectual property acquired from Kissei included extensive preclinical and clinical safety data.

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Make-or-Break Time for Cancer Drugs

Strong presentations at the key oncology conference in late May will be crucial for struggling biotechs

 

Drugs that don't find financing may be the most promising William Taufic/Corbis

 

Some 60% of new cancer drugs are developed in the labs of biotech firms, many of them startups. But this has been a year of living miserably for the biotech industry, and hundreds of these cancer-focused companies are close to folding as investors flee, stock prices sink to near-nothing, and operating cash dwindles.

 

Their future, and that of a lot of nascent cancer drugs, could be decided at a giant medical conference starting in Orlando on May 29. Some 30,000 oncologists, scientists, stock analysts, and venture capitalists are expected to attend the annual meeting of the American Society of Clinical Oncology (ASCO), the premier showcase for reports of human trials of cancer drugs. Share prices can soar or crash on the quality of the data presented, and struggling biotechs with promising drugs will be trolling the meeting for investors and pharmaceutical partners.

 

Whether they find financial support matters to the broader medical community, because biotechs that fail to do so could end up shelving treatments that might save lives. "Companies that have three drugs in the pipeline may end up going down to two," says Dr. Mark Monane, a biotech analyst with Needham & Co. "Or they may test a drug in only two [cancer types] instead of three or four." Because there is so much serendipity in drug discovery, the drug candidate that gets dropped in a cash crunch might, in fact, have the greatest potential, says Glen Giovannetti, head of Ernst & Young's biotech consulting team. "You could see a slowing of innovation."

 

Anticipation of positive results at ASCO has brightened the prospects of some drugs. After brief summaries of upcoming presentations were released on May 14, the stocks of several biotechs shot up, among them Cougar Biotechnology (CGRB) and OncoGenex Pharmaceuticals (AGXI), both close to running out of cash.

 

Cougar no longer needs to worry—Johnson & Johnson (JNJ) announced on May 21 that it would pay close to $1 billion for the six-year-old Los Angeles company. The biotech is in the final stages of testing a drug, Abiraterone, that has shown promise against late-stage prostate cancer.

 

OncoGenex's stock hit new highs five days in a row in late May, going from $4 a share in April to $14, in anticipation of the ASCO presentation on its own prostate cancer drug, OGX-11. In early trials the drug appeared to help patients live longer, but OncoGenex had only $9.4 million in cash at the end of March, not enough to fund the next round of clinical trials. Biotech analysts say ASCO gives the company a good chance to find a financing deal.

 

Plenty of other struggling biotechs are counting on networking opportunities at ASCO as well, among them Poniard Pharmaceuticals (PARD), Sunesis Pharmaceuticals (SNSS), and Cell Therapeutics (CTIC). Cell hopes to file with the Food & Drug Administration in June for approval of Pixantrone, a treatment for late-stage non-Hodgkin's lymphoma.

 

It's something of a miracle, though, that the company is still in business. Just before Cell ran out of cash last fall an unnamed investor came to its rescue. In February it sold off the rights to the one drug it had on the market in order to keep its doors open. The stock collapsed from $50 a share two years ago to as low as 6 cents in February. "It's been ugly times the last 12 months," admits Chief Executive Officer Dr. James A. Bianco .

 

Bianco says positive data from ASCO will change all that, and already the stock has climbed to $1.24 since the clinical trial summary on Pixantrone was released on May 14. "ASCO provides a forum where the data can speak for itself," says Bianco.

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NERI and ProMedica team up to offer Ph I-IV research solutions

US CROs NERI and the ProMedica Clinical Research Center have teamed up to offer comprehensive Phase I-IV trial services to the drug industry.

 

The firms explained that combining ProMedica's expertise in Phase I development with the New England Research Institute's (NERI) experience in later stage studies will provide customers with an integrated trial process and improve efficiency.

 

The contract research organisations (CRO) highlighted NERI's study feasibility, protocol design, regulatory affairs and ProMedica's bioavailability, bioequivalence, pharmacodynamics and toxicity as key strengths of the new alliance.

 

ProMedica CEO Richard Parker said that: "We know that our Phase I research experience combined with NERI's Phase II-IV track record will provide our clients with a comprehensive portfolio of services to choose from.

 

"Through this strategic alliance we offer an expanded and committed team of professionals to tackle any clinical research challenge with consistent standards of excellence."

 

Parker's thoughts were echoed by NERI's Vice president of clinical research Rebecca Li who suggested that the partnership can "provide expanded CRO services to clinical sponsors that are looking to build long-term relationships."

 

Efficiency key for CROs

 

The NERI and ProMedica collaboration's focus on efficiency and offering an integrated Phase I to IV development process is particularly timely given the findings of a recent survey by Cutting Edge Research.

 

Of the 21 drugmakers surveyed, 19 ranked a CRO's ability to hit deadlines as being "extremely important," with a significant proportion suggesting that it is even more important a factor than cost.

 

How the partnership will fare in the global market remains to be seen, especially given the recent disappointing performance of larger rivals like Covance, Charles River and Parexel.

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Oral VDA CYT997 - Phase I Clinical Trial Presentation at ASCO

MELBOURNE, Australia, May 28 /PRNewswire-FirstCall/ -- Cytopia Limited (ASX: CYT) announced that it will present preliminary data from its Phase I clinical trial of orally administered CYT997, at the Annual Meeting of the American Society of Clinical Oncologists (ASCO), in Orlando, Florida, USA.

 

Dr Alessandra Francesconi, one of the clinical investigators for the program, will be presenting the poster in the Developmental Therapeutics - Vascular Targeting poster session on Saturday 30th May from 8:00 AM to 12:00 PM (US EST), Level 2, West Hall C.

 

The poster entitled "Phase I evaluation of orally-administered CYT997, a novel cytotoxic vascular-disrupting agent, in patients with advanced cancer" details safety, tolerability and preliminary activity findings from this study, which concluded in February 2009. CYT997 is currently undergoing further clinical investigation in Phase II studies in relapsed glioblastoma multiforme and multiple myeloma.

 

Enquiries

 

    Dr. Gregg Smith                                         Mr. Andrew Macdonald
    Director, Drug Development and Operations    Chief Executive Officer
    T: +61 3 9208 4234                                   T: +61 3 9208 4232
    gregg.smith@cytopia.com.au                       andrew.macdonald@cytopia.com.au

 

About Cytopia

 

Cytopia Ltd is an Australian biotechnology company focused on the discovery and development of new drugs to treat cancer and other diseases. Cytopia conducts its research and drug development through subsidiaries based in Australia and the USA and specializes in developing new small molecule compounds with an improved therapeutic profile for the treatment of cancer.

 

The company's lead drug candidate is CYT997, a vascular disrupting agent (VDA) for the treatment of various cancers, which is currently being trialed in Phase II clinical studies. Cytopia is continuing to build on its range of JAK inhibitors and kinase expertise, with CYT387, a novel oral JAK2 inhibitor focused on the treatment of myeloproliferative disorders, expected to enter Phase I clinical studies in mid 2009.

 

Website: www.cytopia.com.au

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Phase II Study of Capecitabine and Oxaliplatin for Advanced Adenocarcinoma of the Small Bowel and Ampulla of Vater

From the Department of Gastrointestinal Medical Oncology; and the Department of Biostatistics and Applied Mathematics, The University of Texas M. D. Anderson Cancer Center, Houston, TX.

 

Corresponding author: Michael J. Overman, MD, Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 426, Houston, TX 77030; e-mail: moverman@mdanderson.org.

 

Purpose Adenocarcinomas of the small bowel and ampulla of Vater represent rare cancers that have limited data regarding first-line therapy. We conducted a phase II trial to evaluate the benefit of capecitabine in combination with oxaliplatin (CAPOX) in patients with advanced adenocarcinoma of small bowel or ampullary origin.

 

Patients and Methods Eligible patients with metastatic or unresectable tumors and no prior systemic chemotherapy for advanced disease participated in this phase II trial. CAPOX was administered as a 21-day cycle with oxaliplatin 130 mg/m2 on day 1 and capecitabine 750 mg/m2 twice a day on days 1 through 14. The primary end point was overall response rate as assessed by Response Evaluation Criteria in Solid Tumors.

 

Results Thirty-one patients were enrolled onto the study, and 30 patients received study treatment. The confirmed overall response rate was 50%; three patients with metastatic disease achieved complete responses. The median time to progression (TTP) was 11.3 months, and the median overall survival (OS) was 20.4 months. Subset analysis of patients with metastatic disease only (n = 25) revealed a median TTP of 9.4 months and median OS of 15.5 months. The most common grades 3 or 4 toxicities included fatigue (30%), peripheral neuropathy (10%), vomiting (10%), diarrhea (10%), and neutropenia (10%).

 

Conclusion When administered to patients with good performance status, CAPOX is well tolerated and produces a superior response rate and longer OS compared with other regimens in the literature. CAPOX should be considered a new standard regimen for advanced small bowel and ampullary adenocarcinomas.

 

Supported by Sanofi-aventis and by the Stephen and Mary Birch Foundation.

 

Presented in part at the 4th American Society of Clinical Oncology Gastrointestinal Symposium, January 19-21, 2007, Orlando, FL, and at the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL.

 

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

 

Clinical trial information can be found for the following: NCT00354887.

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FDA, Clinical Trial Updates: Heart Stents, Cholesterol in the News

 

 

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

 

Genzyme [GENZ: 58.37, -0.29 (-0.49%)] and Isis Pharma [ISIS: 13.13, -0.37 (-2.74%)] announced on 5/20/09 that the Phase 3 clinical trial of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25% reduction in LDL cholesterol after 26 weeks of treatment compared to a 3% placebo reduction (p<0.001). This study also met each of its three secondary endpoints of reduction in levels of apolipoprotein B, total cholesterol, and non-HDL cholesterol (all p<0.001). Data from this phase 3 study of mipomersen in patients with hoFH will form the basis of Genzyme's initial regulatory filing for marketing approval, which is expected to occur during 2H10.

 

Although the patients were on maximally tolerated statins and other lipid-lowering therapies, their average LDL-C at baseline was greater than 400 mg/dL. The reductions observed in the study were in addition to those achieved with the patients' existing therapeutic regimen. Full data from the study will be presented at a future medical meeting. Consistent with previous studies evaluating mipomersen, the most commonly observed adverse events were injection site reactions, flu-like symptoms, and elevations in liver enzymes. Of the 34 patients treated with mipomersen, 28 completed the study. One patient discontinued due to elevations in liver enzymes.

 

On 5/20/09, Dainippon Sumitomo Pharma (TYO:4506) (PINK:DNPUF) announced positive results from its first Phase 3 clinical trial for lurasidone, which is under global clinical development for the treatment of patients with schizophrenia. In this six-week, double-blind, placebo-controlled trial, lurasidone 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. In addition, lurasidone was well-tolerated and had a relatively low discontinuation rate. The Company intends to file a New Drug Application (NDA) for FDA approval upon completion of its Phase 3 clinical development program.

 

Lurasidone has been studied in three double-blind, placebo-controlled, six-week trials involving more than 650 patients with schizophrenia, of which 392 patients received lurasidone. Two of the three studies demonstrated that lurasidone had superior efficacy compared to placebo at doses ranging between 40 mg and 120 mg/day. A third study, which examined three fixed doses of lurasidone (20 mg, 40 mg, and 80 mg/day) did not show statistical differences vs. placebo. This trial is regarded as "failed," or inconclusive, as haloperidol (10 mg/day), which was included for purposes of assay sensitivity, also failed to distinguish from placebo. These data showed that lurasidone was well tolerated with a low propensity for EPS, QTc interval changes and weight, lipid and glucose adverse effects. Adverse events seen in the three trials were generally mild.

 

On 5/19/09, NicOx [NICXF: 0.00, N/A (N/A)] announced that quality of life and utility results from its first Phase 3 clinical trial for naproxcinod were presented at the International Society For Pharmacoeconomics and Outcomes Research Annual International Meeting in Orlando, FL. Naproxcinod is a novel type of anti-inflammatory agent, which completed a Phase 3 clinical program last year in patients with osteoarthritis.

 

The drug is designed to have an improved side effect profile (including a neutral effect on blood pressure) as compared to a standard dose of the widely used NSAID drug naproxen. Naproxcinod has completed three pivotal Phase 3 studies with positive results and NicOx expects to submit a NDA by mid-2009 for FDA approval, in addition to presenting the utility and quality of life data from the full Phase 3 program before year-end.

 

Johnson & Johnson [JNJ: 54.77, -0.22 (-0.40%)]: On 5/20/09, JNJ announced new clinical trial results which demonstrated that the NEVO Sirolimus-eluting Coronary Stent was superior to Boston Scientific's [BSX: 8.80, 0.00 (0.00%)] Taxus Liberte Stent in reducing tissue growth within the stent that can potentially lead to repeat procedures. In addition, no reports of stent thrombosis were reported in patients treated with NEVO through six months. The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.

 

NEVO is the first drug-eluting stent utilizing RES Technology, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75% bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100% of their surfaces coated with drug and polymer; and the polymer is never fully bio-absorbed.

 

The NEVO Sirolimus-eluting Coronary Stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64% in the NEVO arm as compared to the Taxus Liberte arm (0.13 mm compared to 0.36 mm, p<0.001). In-stent late lumen loss, which is tissue growth within a stent, reduces the diameter of the lumen thus restricting blood flow through the stent and can potentially lead to major adverse coronary events.

 

Data from this trial will support a regulatory filing for a CE mark in countries outside the U.S. while results from the pending NEVO II clinical trial will provide long-term data in support of a Pre-Market Approval (PMA) application with the FDA to market the stent domestically.

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BIOTRONIK TO SUPPLY ICD TECH TO CARDIO3 BIOSCIENCES FOR C-CURE

BIOTRONIK to Supply ICD Technology to Cardio3 BioSciences for C-Cure? Stem Cell Clinical Trial Agreement places BIOTRONIK at centre of an innovative research /scientific area Health/Medical Writers BERLIN -(BUSINESS WIRE) - May. 22, 2009-- BIOTRONIK, the pioneer in wireless remote monitoring technology for patients with cardiac devices, announced today an agreement regarding a partnership with Belgian biotechnology company Cardio3 BioSciences in their C-Cure? stem cell clinical trial. This pivotal trial is designed to evaluate the safety and efficacy of Cardio3 BioSciences' second generation stem cell therapy in patients with heart failure. The first patient was treated in March 2009.

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Lilly to enrol patients for 2 identical phase III trials of solancezumab

Eli Lilly and Company will begin enrolling patients this month in two separate but identical phase III clinical trials of solanezumab, previously referred to as LY2062430, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The trials, called Expedition and Expedition 2, will each include a treatment period that lasts 18 months and are expected to enrol a total of 2,000 patients age 55 and over from 16 countries.

 

In 2008, Lilly began enrolling patients in two phase III clinical trials called Identity and Identity 2 for a different potential treatment for Alzheimer's disease, a gamma-secretase inhibitor that also affects amyloid beta, which is believed to be one of the underlying pathologies of the disease.

 

The Expedition clinical trials are identical multicenter, randomized, double-blind, placebo-controlled trials. Patients enrolled in the trials will be randomized in a 1:1 ratio (500 patients in each trial arm) to receive intravenous infusions of either placebo or 400 mg of solanezumab once every four weeks. Patients who are taking currently available symptomatic treatments for Alzheimer's disease can continue treatment during their participation in the Expedition trials. The primary objective of both trials is to test whether solanezumab will slow the cognitive and functional decline of Alzheimer's disease patients as compared with placebo. These outcomes will be analyzed using measures of the Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-COG(11)), which measures cognitive function with an emphasis on memory, and the Alzheimer's Disease Cooperative Study - Activities of Daily Living scale (ADCS-ADL), which measures the ability to independently perform daily activities such as eating, bathing, and using the telephone. Secondary objectives of the trials include different clinical benefits as measured by several brain-scanning and biochemical biomarkers and ratings scales, and quality of life impact.

 

"Current therapies available to treat Alzheimer's disease may help with symptoms, but they haven't been proven to change the disease progression," said Eric Siemers, medical director, Alzheimer's disease research for Eli Lilly and Company. "Biomarker results from a phase-II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimer's disease."

 

Alzheimer's disease theory suggests that amyloid beta clumps together and eventually kills brain cells. Solanezumab binds specifically to soluble amyloid beta and thereby may draw the peptide away from the brain through the blood.

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Aastrom suspends US phase II IMPACT-DCM trial after a patient dies

Aastrom Biosciences Inc, a leading developer of autologous adult stem cell treatments for severe chronic cardiovascular diseases, announced that the company has temporarily suspended enrolment and patient treatment in its US phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial.

 

The patient's cause of death has not yet been determined and is the subject of a pending investigation at the clinical site. An independent Data Safety Monitoring Board (DSMB) will also assess the circumstances of the event.

 

In accordance with standard operating procedures, the company has informed the US Food and Drug Administration (FDA) of the following: the death of the patient after being released from the hospital; the initiation of an investigation into the cause of death; and that the Company has voluntarily suspended patient enrolment and treatment in the trial. Subsequently, the FDA placed the trial on temporary clinical hold pending an investigation. Follow-up of patients previously enrolled in the IMPACT-DCM trial will continue in accordance with study protocol.

 

"Patient safety has been and continues to be our primary concern," stated Elmar R Burchardt, vice president, Medical Affairs at Aastrom. "We will continue to work closely with the trial site, the DSMB and the FDA to review the events surrounding the death of one of the patients in this clinical trial. We remain committed to ensuring patient safety and will work to resume patient enrolment and treatment in the IMPACT-DCM trial as soon as possible."

 

Upon completion of the investigation, Aastrom will work closely with the FDA to provide any information required in order to expedite its review and to resolve this matter so that patient enrolment into the IMPACT-DCM trial can resume as soon as possible. Aastrom will provide updated guidance regarding projected patient enrolment once the FDA has made its determination.

 

IMPACT-DCM is the first clinical trial in the US to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM) in both ischemic and non-ischemic patients. Patients randomized into the treatment group of the IMPACT-DCM trial are treated with Aastrom's Cardiac Repair Cells (CRCs), an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells produced from a small sample of the patient's own bone marrow.

 

DCM is a condition where enlargement of the patient's heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends upon the stage of the disease but is typically characterized by numerous health problems and a very high mortality rate.

 

Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue.

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A Phase I/II Clinical Trial in Localized Prostate Cancer of an Adenovirus Expressing Nitroreductase with CB1984

CR UK Institute for Cancer Studies, University of Birmingham, Birmingham, UK.

 

We report a phase I/II clinical trial in prostate cancer (PCa) using direct intraprostatic injection of a replication defective adenovirus vector (CTL102) encoding bacterial nitroreductase (NTR) in conjunction with systemic prodrug CB1954. One group of patients with localized PCa scheduled for radical prostatectomy received virus alone, prior to surgery, in a dose escalation to establish safety, tolerability, and NTR expression. A second group with local failure following primary treatment received virus plus prodrug to establish safety and tolerability. Based on acceptable safety data and indications of prostate-specific antigen (PSA) responses, an extended cohort received virus at a single dose level plus prodrug. The vector was well tolerated with minimal side effects, had a short half-life in the circulation, and stimulated a robust antibody response. Immunohistochemistry of resected prostate demonstrated NTR staining in tumor and glandular epithelium at all dose levels [5 x 10(10)-1 x 10(12) virus particles (vp)]. A total of 19 patients received virus plus prodrug and 14 of these had a repeat treatment; minimal toxicity was observed and there was preliminary evidence of change in PSA kinetics, with an increase in the time to 10% PSA progression in 6 out of 18 patients at 6 months.

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Bioniche Phase III Clinical Trial with Urocidin(TM) Progressing Well

Bioniche Life Sciences Inc. ("Bioniche"; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer. On March 31st, the Company announced that recruitment had been completed in its initial Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy - Bacillus Calmette-Guerin (BCG).

The Data Safety Monitoring Committee (DSMC) held its eighth meeting regarding this clinical trial earlier this week. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next scheduled meeting of the Committee is July.

The DSMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the safety and efficacy data generated in the trial. On a regular basis, the DSMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.

Data from the full cohort of 105 high-grade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDA's Accelerated Approval program.

Second Phase III Registration Trial

Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year. The Company expects to start this trial at such time as it has a development and marketing partner in place.

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Clinical Trials for Herbal theraphy for men with high risk of prostrate cancer finished

I don't really believe in any herbal supplements unless they're backed by clinical trials. Anyways, also the phase 1 trials for Zyflamend, an herb-based therapeutic, seems promising it has still to undergo more clinical trials to say that findings are conclusive.

 

Anyways, the results of the phase 1 clinical trial shows that Zyflamend demonstrates minimal toxicity and no serious adverse events in men with high risk of developing prostrate cancer.

 

The study was conducted on 23 men, aged 40-75 who were diagnosed with HGPIN at biopsy, meaning they were at high risk for developing prostrate cancer. Zyflamend was ingested orally for 18 months and the results show that Zyflamend when taken in a dose of three times daily for 18 months, were well tolerated. Studies have already indicated that Zyflamend may have anti-inflammatory properties that have been shown to decrease the risk of prostrate cancer.

 

This study was published in the Journal of the Society for Integrative Oncology.

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Aastrom Places Phase II IMPACT-DCM Clinical Trial On Hold

Aastrom Biosciences (ASTM 0.36 ↓14.31%), Inc. (Nasdaq:ASTM), a leading developer of autologous adult stem cell treatments for severe chronic cardiovascular diseases, today announced that the Company has temporarily suspended enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The patient's cause of death has not yet been determined and is the subject of a pending investigation at the clinical site. An independent Data Safety Monitoring Board (DSMB) will also assess the circumstances of the event.

 

In accordance with standard operating procedures, the Company has informed the U.S. Food and Drug Administration (FDA) of the following: the death of the patient after being released from the hospital; the initiation of an investigation into the cause of death; and that the Company has voluntarily suspended patient enrollment and treatment in the trial. Subsequently, the FDA placed the trial on temporary clinical hold pending an investigation. Follow-up of patients previously enrolled in the IMPACT-DCM trial will continue in accordance with study protocol.

 

"Patient safety has been and continues to be our primary concern," stated Elmar R. Burchardt, M.D., Ph.D., Vice President, Medical Affairs at Aastrom. "We will continue to work closely with the trial site, the DSMB and the FDA to review the events surrounding the death of one of the patients in this clinical trial. We remain committed to ensuring patient safety and will work to resume patient enrollment and treatment in the IMPACT-DCM trial as soon as possible."

 

Upon completion of the investigation, Aastrom will work closely with the FDA to provide any information required in order to expedite its review and to resolve this matter so that patient enrollment into the IMPACT-DCM trial can resume as soon as possible. Aastrom will provide updated guidance regarding projected patient enrollment once the FDA has made its determination.

 

IMPACT-DCM is the first clinical trial in the U.S. to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM) in both ischemic and non-ischemic patients. Patients randomized into the treatment group of the IMPACT-DCM trial are treated with Aastrom's Cardiac Repair Cells (CRCs), an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells produced from a small sample of the patient's own bone marrow.

 

DCM is a condition where enlargement of the patient's heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends upon the stage of the disease but is typically characterized by numerous health problems and a very high mortality rate.

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Rexahn Achieves 50% Enrollment Milestone In SerdaxinT Phase IIa Clinical Trial For Depression

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), announced that it has enrolled 50% of the total projected enrollment required for its Phase IIa trial to evaluate the safety and preliminary efficacy of Serdaxin™ as a central nervous system based treatment for Major Depressive Disorder (MDD). The complete trial calls for the enrollment of up to 80 patients at multiple clinical trial sites in the United States.

 

"This patient enrollment milestone in the Serdaxin clinical trial is an exciting step forward. We anticipate that enrollment will continue to move quickly, and preliminary study results may be available by year end. Serdaxin is of particular importance in meeting unmet needs in depression, because it appears to have fast onset of action in animal models and lacks the serious side effects associated with existing antidepressant drugs, including nausea, vomiting, insomnia, weight gain and sexual dysfunction." Said Dr. Chang Ahn, CEO of Rexahn

 

The Serdaxin Phase IIa clinical trial is designed as a randomized, double blind, placebo controlled and dose ranging study. Main endpoints include clinically validated depression rating scales, and quality of life surveys. The Serdaxin Phase IIa study in MDD was initiated February 2009, and the Company anticipates completion of enrollment by July 2009.

 

Rexahn will be presenting at the BIO 2009 International Convention at the Georgia World Congress Center (Room 314, Building A, Level 3) in Atlanta, GA on Wednesday, May 20, 2009 at 3:00 PM ET.

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Celator Pharmaceuticals, Inc. Initiates Research Agreement With Cephalon, Inc.

Celator Pharmaceuticals today announced that it has entered into a research agreement with Cephalon, Inc. . The research agreement provides for the exploration of the application of Celator's proprietary technology to an ongoing drug development and life-cycle management program at Cephalon.

 

"This agreement provides an opportunity to leverage the technology and expertise at Celator beyond our own pipeline," said Scott Jackson, chief executive officer, Celator Pharmaceuticals. "It is exciting to advance our capabilities with such a high caliber partner as well as through progress in our clinical programs. We believe our technology has the potential to improve clinical outcomes with a wide variety of cancer products and we continue to seek additional partners."

 

"Celator has developed unique capabilities in liposomal and nano-particle encapsulation," said Jeffry Vaught, Ph.D., chief scientific officer at Cephalon. "Exploring their utility for Cephalon pipeline compounds is entirely consistent with our commitment to use drug delivery technology to optimize treatment and improve patient care."

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Cytokinetics to Present Phase IIa Clinical Trials Data on CK-1827452 at the 2009 Heart Failure Congress of the European Society of Cardiology

Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that data relating to two Phase IIa clinical trials evaluating CK-1827452, one in stable heart failure patients and one in patients with ischemic cardiomyopathy and angina, are scheduled to be presented in two poster presentations and in the late breaking trials session at the 2009 Heart Failure Congress of the European Society of Cardiology, to be held May 30-June 2, 2009, at the Nice Acropolis Palais des Congrès et Expositions in Nice, France.

 

Late Breaking Trials Session

 

The late breaking presentation titled "The Selective Cardiac Myosin Activator, CK-1827452, Increases Systolic Function in Heart Failure" will be presented on Monday, June 1, 2009 from 11:00 AM - 12:30 PM Central European Time in the Apollon Auditorium by John Cleland, MD, FACC, FRCP, FESC, Professor of Cardiology, Castle Hill Hospital, University of Hull, United Kingdom.

 

Poster Presentations

 

Program #149: "Echocardiographic Detection of Increases in Ejection Fraction in Patients with Heart Failure Receiving the Selective Cardiac Myosin Activator, CK-1827452" is scheduled to be displayed in the session titled "Medical and Surgical Treatments Poster Session: Drug Therapy, Other" on Sunday, May 31, 2009 from 8:30 AM - 12:30 PM Central European Time in the Clinical Poster Zone. The poster will be moderated by Jonathan H. Goldman, MD, FACC, Chief Medical Officer, ICON Medical Imaging, Warrington, PA from 10:00 AM - 11:00 AM.

 

Program #174: "Phase II Safety Study Evaluating the Novel Cardiac Myosin Activator, CK-1827452, in Patients with Ischemic Cardiomyopathy and Angina" is scheduled to be displayed in the session titled "Medical and Surgical Treatments Poster Session: Drug Therapy, Other" on Sunday, May 31, 2009 from 8:30 AM - 12:30 PM Central European Time in the Clinical Poster Zone. The poster will be moderated by Barry H. Greenberg, MD, Chair of the Safety Review Committee for this clinical trial and Director, Advanced Heart Failure Treatment Program, University of California, San Diego Medical Center from 10:00 AM - 11:00 AM.

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Intrexon Initiates Phase 1b Clinical Trial in Advanced

Intrexon Corporation, a Salem, Virginia-based biotechnology company, announced that it has initiated treatment of the first patient in its Phase 1B clinical trial of INcell-1001/AD-1001 in patients with Stage III/IV melanoma. INcell-1001/AD-1001 is Intrexon's most advanced immunomodulatory therapy. INcell-1001 is intended to control and enhance the immune-modulating performance of dendritic cells to treat solid tumor cancers. The trial is an open-label, dose-escalation study evaluating the safety, tolerance, transgene function, pharmacokinetics and immunological effects of intratumoral injection of transduced dendritic cells (INcell-1001). INcell-1001 has been engineered for inducible expression of human Interleukin 12 (hIL-12) using regimented dosing of an orally administered small molecule (AD-1001).

 

The primary endpoints of the Phase 1B study are the safety and tolerability of INcell-1001 induced by escalating doses of the activator AD-1001. Secondary endpoints include the pharmacodynamics of the AD-1001/INcell-1001 combination, as represented by hIL-12 expression levels, plus anti-tumor activity, as represented by cellular immune responses within the target tumor, draining lymph nodes and peripheral circulation.

 

Further information regarding this Phase 1B study can be obtained using the search identifier NCT00815607 at the NIH clinical trials website: www.clinicaltrials.gov.

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Scientists shed new light on why pancreatic cancer drugs can fail

CANCER RESEARCH UK scientists led an international team of investigators who have discovered a new mechanism that may explain why pancreatic cancer patients are often resistant to a common chemotherapy treatment called gemcitabine*, according to a study published in Science** today (Thursday).

 

It is hoped this study will help scientists overcome a common resistance to gemcitabine and make future chemotherapy drugs more effective.

 

Pancreatic cancer is diagnosed in 230,000 people across the world***, with 7,600 new cases in the UK and 37,000 new cases in the United States each year. Only three per cent of patients survive for five years or more.

 

The scientists at Cancer Research UK's Cambridge Research Institute - who were co-funded by The Lustgarten Foundation and the National Institutes of Health, sought to understand why promising drugs generally fail in pancreatic cancer clinical trials. They found that a genetically modified mouse model of pancreatic cancer that closely resembles human cancer was also largely resistant to gemcitabine treatment.

 

The scientists found in these mouse studies that pancreatic cancer is resistant to chemotherapy because the tumours tend to have poor networks of blood vessels called vasculature, which makes it harder for drugs to reach the tumour.

 

Working with groups at Addenbrooke's Hospital, the Johns Hopkins Hospital, the MD Anderson Cancer Centre, University of Pittsburghand the Fred Hutchison Cancer Research Centre, the group also noted that human pancreatic cancer samples also contained a deficient blood supply, suggesting that their observation should also be applicable to patients.

 

Senior author Dr David Tuveson, group leader in tumour modeling and experimental medicine at Cancer Research UK's Cambridge Research Institute, said: "We're extremely excited by these results as they may help explain the disappointing response that many pancreatic cancer patients receive from chemotherapy drugs."

 

The study also found that the genetically modified mice displayed the same resistance to gemcitabine as seen in human pancreatic cancer, whereas the transplantation mouse models traditionally used to develop chemotherapy treatments were sensitive to gemcitabine. This means that the new genetically modified models could prove superior in developing new treatments in the future.

 

When the scientists used a new compound called IPI-926****, which was created by Infinity Pharmaceuticals, in combination with gemcitabine in the genetically modified animals, they noticed increased cell death and a reduction of the pancreatic tumour size. They believe that using this combination may also re-open the door to several new treatments which have, so far, proven disappointing in patient trials for pancreatic cancer because of poor drug delivery.

 

"But these are early days and we need to show this approach is safe to use in humans before we can consider adding the new compound to cancer treatments," said Dr Tuveson.

 

These findings may also help to explain why pancreatic cancer does not respond to anti-angiogenic drugs such as VEGF inhibitors when many other cancers do. These are a new class of drugs which starve the tumour by restricting its blood supply. As pancreatic cancers don't seem to need as good a supply of blood to the tumour as other cancers, the scientists believe that they may need to introduce additional drugs to help stop tumour growth.

 

Kerri Kaplan, executive director of The Lustgarten Foundation, the largest private funder of pancreatic cancer research in the United States, said: "Because pancreatic cancer is so difficult to treat with standard chemotherapy, these study results demonstrate progress toward greater understanding of how to treat this swift, silent and deadly disease. The Foundation remains committed to supporting research that improves our understanding of pancreatic cancer, in the hope that one day, early diagnostic tools and new, improved treatments can be found."

 

Dr Lesley Walker, Cancer Research UK's director of cancer information said: "This is a very substantial finding. If these results hold in future studies, we hope that scientists will be able to make better use of current treatments and develop a range of new options which will help people with pancreatic cancer live longer.

 

"Cancer Research UK's five year strategy highlights the importance of targeting areas of unmet medical need, such as pancreatic cancer, so we can have the greatest impact on reducing cancer deaths in the future. Results like these give us real confidence that we will combine this focus with our other research efforts and meet our goals of improving survival from all forms of the disease."

 

ENDS

 

For media enquiries, please contact the Cancer Research UK press office on 020 7061 8311 or, out of hours, the duty press officer on 07050 264 059.

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Targeting targeted agents: open issues for clinical trial design

Molecularly targeted agents for the treatment of solid tumors had entered the market in thelast 5 years, with a great impact upon both the scientific community and the society. Many randomized phase III trials conducted in recent years with new targeted agents, despite previous data coming from preclinical research and from phase II trials were often promising, have produced disappointingly negative results.

 

Some other trials have actually met their primary endpoint, demonstrating a statistically significant result favouring the experimental treatment. Unfortunately, with a few relevant exceptions, this advantage is often small, if not negligible, in absolute terms.

 

The difference between statistical significance and clinical relevance should always be considered when translating clinical trial results in the practice. The reason why this revolution did not significantly impact on cancer treatment to displace chemotherapy from the patient'bedside is in part due to complicated, and in many cases, unknown, mechanisms of action of such drugs; indeed, the traditional way the clinical investigators were used to test the efficacy of 'older'chemotherapeutics, has become out of date from the methodological perspective.

 

As these drugs should be theoretically tailored upon featured bio-markers expressed by the patients, the clinical trial design should follow new rules based upon stronger hypotheses than those developed so far. Indeed, the early phases of basic and clinical drug development are crucial in the correct process which is able to correctly identify the target (when present).

 

Targeted trial designs can result in easier studies, with less, better selected, and supported by stronger proofs of response evidences, patients, in order to not waste time and resources.

 

Author: Emilio BriaMassimo Di MaioPaolo CarliniFederica CupponeDiana GiannarelliFrancesco CognettiMichele Milella
Credits/Source: Journal of Experimental &Clinical Cancer Research 2009, 28:66

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Drug Cuts Amputation Risk in Diabetes

Treating type 2 diabetes patients with a cholesterol-lowering drug called fenofibrate cuts the risk of a first diabetes-related limb amputation by 36%, according to a new study published this week in The Lancet.

 

"I would call that a substantial reduction in risk," says James Best, MD, professor of medicine at the University of Melbourne in Australia and a co-author of the study.

 

The reduction in limb amputation risk is probably not directly related to the cholesterol-lowering effects of the drug, he tells WebMD, but rather to some of the other effects, such as improving the functioning of small blood vessels.
Amputation & Type 2 Diabetes: Background

 

People with diabetes are more likely than people without the condition to have a foot or leg amputation, according to the American Diabetes Association.

 

That's because people with diabetes are likely to have peripheral artery disease, reducing blood flow to the lower legs and feet, and to have nerve disease called diabetic neuropathy, boosting their risk of getting ulcers and infections that can result in a need for amputation.
Fenofibrate & Amputation Risk: Study Details

 

Best and his colleagues looked at 9,795 patients in Australia, New Zealand, and Finland with type 2 diabetes, aged 50 to 75, who had taken part in the FIELD study (Fenofibrate Intervention and Event Lowering in Diabetes). The patients were assigned to get either fenofibrate at a dose of 200 milligrams a day or placebo for five years.

 

FIELD is a clinical trial that previously analyzed the drug's effect on heart disease death and nonfatal heart attack and showed it did not have a significant effect on those outcomes, but it did help with other problems, such as reducing risk of diabetic retinopathy, a diabetes-related eye problem.

 

Among the funding sources were Laboratoires Fournier SA, now part of Solvay Pharmaceuticals, which markets fenofibrate, and the National Health and Medical Research Council of Australia.

 

The researchers got information on amputation and whether they were minor, defined as below the ankle, or major, defined as above the ankle.

 

They also assessed whether large blood vessel disease or small blood vessel disease was found in the amputated limb.
Fenofibrate & Amputation Risk: Study Results

 

Over the course of the study, 115 patients had amputations of the lower limbs related to their diabetes. The researchers also found:

 

    * Overall, the risk of first amputation was 36% lower for all patients given fenofibrate compared to those given placebo. Although 70 of those on placebo had amputation, 45 of those on the drug did.
    * The risk of minor amputation in patients who did not have large vessel disease was even lower, 47%, for those who took the drug compared to those who got the placebo.
    * Risks didn't differ significantly between groups for major amputations.
    * Height predicted risk of amputation. For every 4-inch increase in height, there was a 1.6-times boost in risk. (Best notes that this is not a new finding.)

 

Fenofibrate & Amputation: Take-Home Message

 

Best puts the study findings in perspective this way. "What we have to keep in mind is that amputation is not as common as heart attack [among those with type 2 diabetes]." Although the effect of the drug on amputation risk was significant, he says, "This doesn't mean everyone with diabetes should start taking fenofibrate to prevent amputation. The therapy should be targeted to those at high risk for amputation."

 

That includes those who have nerve damage in their feet from their diabetes, who have an ulcer on their foot, or who have had a previous amputation, Best says.
Fenofibrate & Amputation: Second Opinions

 

"It's an interesting study that may change some people's approach [to diabetes treatment]," says Richard Jackson, MD, senior physician at Joslin Diabetes Center and assistant professor of medicine at Harvard Medical School, Boston, who occasionally does prescribe the drug, typically to bring down high triglyceride levels.

 

But he adds a caveat. "The medication could be helpful, but it's only one study." More studies are needed, he says.

 

Another expert who reviewed the study findings for WebMD agrees. "We need to do a larger trial to understand its mechanism and confirm the findings," says Richard M. Bergenstal, MD, president-elect of the American Diabetes Association and executive director of the International Diabetes Center at Park Nicollete Health Services in Minneapolis.

 

Meanwhile, he says, the study results point to the importance of preventive care. The researchers found that the strongest predictors of a first amputation included a history of previous amputation or diabetic skin ulcers, nerve problem, or a history of peripheral vascular disease. "Anybody who has neuropathy and a history of amputation or ulcer, we need to follow them very closely because they are at higher risk."

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Optimer shares fall on additional data from antibiotic trial

Shares of Optimer Pharmaceuticals Inc fell as much as 18 percent Monday, a day after the company released additional data from a late-stage trial that showed its antibiotic to treat a hospital-acquired infection was comparable but not more effective than standard-of-care among a subset of patients.

 

At least two brokerages downgraded the company based on the

 

subgroup analysis data of its antibiotic fidaxomicin that was presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Helsinki, Finland.

 

In the trial, the recurrence rate among patients with a particularly virulent strain of bacterial infection CDI was 25 percent after being treated with fidaxomicin compared to 24.1 percent for standard-of-care vancocin.

 

CDI, or clostridium difficile infection, can result in anything from severe diarrhea to death and the strain NAP-1 affects about a third of CDI patients.

 

'Without a clear differentiation versus vancocin against NAP-1, we believe the picture is somewhat more mixed and upside to the stock may be more limited,' said Needham & Co analyst Alan Carr and downgraded the stock to 'hold' from 'buy'.

 

Earlier in November, top-line results from the trial showed the drug was more effective than Viropharma Inc's vancocin at lowering recurrence rates in the trial population.

 

The overall recurrence rate was 13.3 percent for fidaxomicin and 24 percent for vancocin.

 

'The imbalances in fidaxomicin data raise questions regarding the (overall) improvement in recurrence rate', said JMP Securities analyst Liisa Bayko, who downgraded the stock to 'market perform' from 'market outperform'.

 

However, not all analysts agree.

 

'There is no strain where the patient would be worse off on fidaxomicin,' said Robert W. Baird analyst Thomas Russo

 

'About one-third of CDI is the NAP-1 strain. So, the value proposition would be that you have a one-in-three chance of doing at least as well or equally well with fidaxomicin and a two-thirds chance of doing better,' Russo added and kept his 'outperform' rating on the stock.

 

He noted that physicians do not know the specific strain of CDI till weeks after they have already treated the patient.

 

Optimer shares were down more than 7 percent at $10.77 in afternoon trade on Nasdaq. They had earlier touched a low of $9.54 in the session.

 

'Investors concerned by a small subgroup analysis are missing the big picture. Fidaxomicin still appears to offer the best possible treatment for the majority of patients with CDI,' said ThinkEquity analyst Brian Skorney.

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U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold

Biopure Corporation (Nasdaq:  BPUR) announced today that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure's oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission, including the most recent, was placed on clinical hold.

 

Under a research agreement with Biopure, the NMRC assumed primary responsibility, subject to funding, for designing, seeking FDA acceptance of and directing a trial for Hemopure's prehospital used in trauma patients with hemorrhagic shock. The NMRC has also developed and submitted a protocol for a trial proposed to be conducted in the field, called Operation RESUS (OP RESUS). The proposed trial hypothesis is that for such casualties, Hemopure will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with "standard fluids." Op RESUS is also on clinical hold, and the company does not expect the FDA to permit RESUS or OP RESUS to proceed in the foreseeable future.

 

The company expects the NMRC to seek FDA approval for a clinical trial of Hemopure with a concomitant drug to address vasoactivity, which occurs with the use of Hemopure alone. The NMRC and the FDA are in discussions concerning such a trial, and the NMRC is conducting preclinical studies recommended by the FDA to prepare for such a trial. The NMRC continues to buy Hemopure for this testing.

 

To date, Congress has appropriated funds for the development of Hemopure for potential use in military and civilian trauma indications and to cover military administrative costs. This funding is being used for trial preparation and for preclinical studies of Hemopure in animal models, including those that mimic military trauma scenarios.

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Stem Cell Therapeutics wins FDA approval to proceed with Phase IIb stroke trial

Canadian biotechnology company Stem Cell Therapeutics has received formal clearance from FDA for removal of the clinical hold placed on the Phase IIb stroke trial. This permits re-initiation of clinical studies for NTx-265.

 

According to Stem Cell Therapeutics, NTx-265 is the company's lead therapeutic regimen of two approved and clinically well-defined drugs, human chorionic gonadotropin and erythropoietin, targeting the treatment of stroke.

 

The twin objectives of the treatment are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual, and cognitive recovery after the acute ischemic stroke.

 

Alan Moore, president and CEO of Stem Cell Therapeutics, said: "We are very pleased that FDA has followed up their verbal confirmation so quickly with a formal letter to lift the clinical hold, allowing us to initiate the Phase IIb clinical trial with limited delay."

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Optimer's Phase III Clostridium difficile infection trial meets endpoint

Optimer Pharmaceuticals, a biopharmaceutical company, has reported encouraging results from its North American Phase III clinical study of fidaxomicin in patients with Clostridium difficile infection.

 

According to Optimer, the trial met its primary endpoint with fidaxomicin achieving clinical cure compared to Vancocin. In addition, patients treated with fidaxomicin experienced a reduction in Clostridium difficile infection (CDI) recurrence compared to Vancocin (p=0.004) and had a higher global cure compared to Vancocin (p=0.006).

 

Additional findings also reported for the first time include a subgroup analysis of clinical cure and recurrence rates for fidaxomicin compared to Vancocin, as well as baseline demographic and disease characteristics. Clinical cure rates for fidaxomicin and Vancocin were similar in each of the following subgroups: patient status (in-patient/out-patient), age (under/over 65) and strain type (BI/NAP1/027).

 

Fidaxomicin showed a reduction across several subgroups in recurrence rates compared to Vancocin in both out-patient and in-patient settings, as well as in patients both over and under the age of 65. The recurrence rates in the BI/NAP1/027 subgroup were similar between fidaxomicin and Vancocin, the company said.

 

Thomas Louie, professor in the departments of medicine and microbiology-infectious diseases at University of Calgary, said: "This study showed that fidaxomicin is as effective as vancomycin for treatment of C Difficile diarrhea, including treatment of infection by the hyper virulent NAP1/ribotype 027 outbreak strain. These findings indicate that fidaxomicin offers both highly effective but more selective therapy that is less damaging to the normal intestinal bacteria that protect against recurrence of CDI."

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Positive preliminary results on clinical trial with anti-cancer drug

Patients' responses to the newly designed anti-cancer drug MGN1703 of MOLOGEN AG exceeded expectations in clinical trial

 

DJ DGAP-Adhoc: Mologen AG: Positive preliminary results on clinical trial with anti-cancer drug MOLOGEN AG / Miscellaneous
18.05.2009

 

Release of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. =

 

Patients' responses to the newly designed anti-cancer drug MGN1703 of MOLOGEN AG exceeded expectations in clinical trial. Therefore the biopharmaceutical company decided to extent the on-going phase 1 study for a further dose increase.

 

The preliminary safety results show a favorable safety profile of MGN1703 in all patients treated with different doses of the cancer drug for up to 6 weeks. The evaluation of systemic and local tolerability of the treatment exhibited very good results up to the dose of 30 mg.

 

A stable disease after completion of 6 weeks treatment was observed in over 40 per cent of the patients. Until now, four of the responding patients were treated for further 6 weeks with the cancer drug. After completion of the extension therapy, an ongoing stable disease was still observed in two of these patients. The efficacy concept has been further confirmed by investigations of the relationship between the administered dose and the drug distribution in the body (pharmacokinetics) conducted within the scope of this clinical trial.

 

Based on the favorable safety and pharmacokinetic results in all treatment groups, Mologen AG has decided to extent the on-going study for a further dose increase. Additional quantities of the cancer drug are currently being manufactured. MOLOGEN expects to announce first results from this additional dose group in the fourth quarter 2009. The company is currently intensively engaged in preparing additional clinical trials investigating the efficacy of MGN1703. A clinical trial phase 2 with colorectal cancer patients is scheduled to start this year.

 

Contact: Jörg Petrass Email: investor@mologen.com Telephone: +49-30-84 17 88-13 Fax: +49-30-84 17 88-50

 

Kirchhoff Consult AG Dr Kay Baden Email: baden@kirchhoff.de Telephone: +49-40-60 91 86 39

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Keryx Biopharmaceuticals Announces Poster Presentations Highlighting Clinical Activity of KRX-0401 (Perifosine) at the Upcoming Annual Meeting of the American Society of Clinical Oncology

Results Will be Reported from Phase 2 Studies Evaluating KRX-0401 in Advanced Renal Cell Carcinoma, Colorectal Cancer and Gastrointestinal Stromal Tumors (GIST)

 

Keryx Biopharmaceuticals, Inc. has announced that four abstracts on KRX-0401 (Perifosine), the Company's Akt-inhibitor for cancer, were accepted for presentation during poster sessions taking place at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held in Orlando, Florida from May 29 to June 2.

 

All of the clinical data to be presented demonstrates the potential clinical efficacy of KRX-0401, both as a single agent and in combination with other approved agents, in the treatment of patients with advanced renal cell carcinoma, colorectal cancer and GIST.

 

Abstracts selected for presentation are as follows:

 

Renal Cell Carcinoma (RCC)

 

Friday, May 29th, 2009:

 

#5034: Phase II study of perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor inhibitor.

 

Lead Author: Nicholas Vogelzang, MD

 

Poster Discussion: 5:00pm-6:00pm (Level 2, West Hall F5)

 

Sunday, May 31st, 2009:

 

#5101: A phase II trial of perifosine in patients with advanced renal cell carcinoma (RCC) who have failed tyrosine kinase inhibitors (TKI).

 

Lead Author: Daniel Cho, MD

 

Poster Session: 2:00pm - 6:00pm (Level 2, West Hall C)

 

Colorectal Cancer

 

Sunday, May 31st, 2009:

 

#4081: Randomized phase II study of perifosine in combination with capecitabine versus capecitabine alone in patients with second- or third-line metastatic colon cancer.

 

Lead Author: Sasha Vukelja, MD

 

Poster Session: 8:00am - 12:00pm (Level 2, West Hall C)

 

Gastrointestinal Stromal Tumor (GIST)

 

Sunday, May 31st, 2009:

 

#10563: A randomized phase II study of perifosine (P) plus imatinib for patients with imatinib-resistant gastrointestinal stromal tumor (GIST).

 

Lead Author: Anthony Conley, MD

 

Poster Session: 2:00pm - 6:00pm (Level 2, West Hall C)

 

Copies of these abstracts are currently available and can be viewed on-line through the ASCO website: http://www.asco.org/.

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Rexahn Achieves 50% Enrollment Milestone in Serdaxin(TM) Phase IIa Clinical Trial for Depression

Rexahn Pharmaceuticals, Inc. has announced that it has enrolled 50% of the total projected enrollment required for its Phase IIa trial to evaluate the safety and preliminary efficacy of Serdaxin(TM) as a central nervous system based treatment for Major Depressive Disorder (MDD). The complete trial calls for the enrollment of up to 80 patients at multiple clinical trial sites in the United States.

 

"This patient enrollment milestone in the Serdaxin clinical trial is an exciting step forward. We anticipate that enrollment will continue to move quickly, and preliminary study results may be available by year end. Serdaxin is of particular importance in meeting unmet needs in depression, because it appears to have fast onset of action in animal models and lacks the serious side effects associated with existing antidepressant drugs, including nausea, vomiting, insomnia, weight gain and sexual dysfunction." Said Dr. Chang Ahn, CEO of Rexahn

 

The Serdaxin Phase IIa clinical trial is designed as a randomized, double blind, placebo controlled and dose ranging study. Main endpoints include clinically validated depression rating scales, and quality of life surveys. The Serdaxin Phase IIa study in MDD was initiated February 2009, and the Company anticipates completion of enrollment by July 2009.

 

Rexahn will be presenting at the BIO 2009 International Convention at the Georgia World Congress Center (Room 314, Building A, Level 3) in Atlanta, GA on Wednesday, May 20, 2009 at 3:00 PM ET.

 

About Serdaxin(TM)

 

Serdaxin(TM) is a potential market leading CNS neuroprotective agent and antidepressant. Among lead indications, we are investigating Serdaxin for depression in Phase II clinical trials. Serdaxin may achieve greater and broader therapeutic coverage, and appears to have no serious side effects such as nausea, vomiting, insomnia, weight gain, sexual dysfunction, cognitive deficit or motor impairment that are linked to existing antidepressant drugs. Serdaxin has well-established and excellent human safety. In preclinical studies, Serdaxin had onset of action in less than two days. Based on its novel mechanism as a dual serotonin and dopamine enhancer, it is a potential treatment for multiple CNS disorders where these neurotransmitters are depleted or implicated in CNS-based illnesses, such as Parkinson's disease (PD). Serdaxin has the potential to address both non-motor and motor events of PD by serving as a neuroprotective agent and addressing loss of dopaminergic neurons that lead to loss of control of movements; and further, enhancing serotonin and dopamine levels that are involved in depression and mood disorders. Rexahn has multiple clinical programs planned for Serdaxin including depression and anxiety disorders, Parkinson's disease, Alzheimer's and neurodegenerative illnesses, neuroprotection and biodefense uses.

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BioVex to Report Phase I/II Clinical Trial Results for the Front Line Treatment of Head and Neck Ca

BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced today that the results from a Phase I/II combination study in previously untreated patients with head and neck cancer will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 29, 2009 - June 2, 2009 in Orlando, FL.

 

The results are to be presented in an abstract (number 6018) entitled, "Phase I/II dose escalation study of OncoVEX GM-CSF and chemoradiotherapy (CRT) in untreated stage III/IV squamous cell cancer of the head and neck (SCCHN)," at a poster session on Friday, May 29, 2009 from 2:00pm - 6:00pm EDT on Level 2, West Hall F3 of the conference. A poster discussion will take place from 5:00pm - 6:00pm EDT.

 

Study Rationale

 

Patients with head and neck cancer often present with bulky disease that is too large or too close to vital organs for surgical removal. These patients typically undergo radiation and chemotherapy treatment prior to surgery. Patients who present with tumor containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years.

 

In this study, OncoVEX GM-CSF was administered by direct injection, at three dose levels, into tumor containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles. All patients then went for surgery. Of the 17 Stage III/IVA (N1-3) patients treated, 16 had N2 or N3 disease.

 

Study Results

 

The abstract, now available online at www.asco.org, reports that OncoVEX GM-CSF was well tolerated, with no significant additional side effects noted over and above those which are common with chemoradiation alone. With respect to efficacy, 94% of patients had a complete pathological response noted at surgery, with five patients achieving a complete response after only 2 or 3 viral doses. No patient has recurred locally in the neck at a median follow up of 26 months at the time of abstract submission. Three patients had distant metastatic disease. Two of these were in the low dose group. One additional low dose patient developed a new primary tumor post treatment. OncoVEX GM-CSF was detected in injected and adjacent uninjected tumors at a therapeutic dose.

 

Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said:

 

"Loco-regional control is extremely important in head and neck cancer where loco regional progression is responsible for the majority of deaths. The two year loco-regional failure rate following front line treatment is around 30% with a further 20% of patients progressing at a distant site. The long term loco-regional control rate of 100% combined with the very high percentage of patients in the mid and high dose groups that remain disease free at up to 36 months from treatment is very encouraging. As a result, OncoVEX GM-CSF clearly warrants further investigation in this setting."

 

Philip Astley-Sparke, President & CEO, for BioVex said:

 

"We are encouraged by these results which echo results in other studies using OncoVEX GM-CSF as a stand alone therapy where it remains the case that no tumor previously eradicated through OncoVEX GM-CSF therapy has been known to recur. The study reported here has demonstrated that combining OncoVEX GM-CSF with standard cancer therapies may also provide clinical benefit. Combinations involving OncoVEX GM-CSF may also allow less aggressive chemo radiation regimens to be employed whilst maintaining similar or better clinical outcomes as compared to more debilitating regimens. Following on from the ongoing pivotal Phase III study in melanoma, we plan to submit a second Phase III protocol in head and neck cancer to the FDA under the SPA procedure this summer."

 

About Head and Neck Cancer

 

Head and neck cancer accounts for 47,000 new cases (3% of all new cancer cases and 2% of all cancer deaths) in the United States annually. It is the fifth most common malignancy worldwide , or an estimated 644,000 new cases annually.

 

Patients with locally advanced tumors are best treated with concurrent chemo radiation, with planned neck dissection indicated in certain patients. Despite aggressive treatment of locally advanced disease loco regional recurrences develop in 30% of patients, distant metastases in 20%. Aggressive combined modality therapy may be frequently associated with debility, and numerous physical and psychological symptoms including pain, dysphagia, weight loss, disfigurement, depression, and xerostomia (dry mouth). As a result, new and improved, and less toxic therapies for head and neck cancer are urgently required.

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Jobs - Clinical trial specialists

Clinical trial specialists

Category  Clinical Research
Job Ref  SK/HQ00008770
Job Type  Permanent
Salary  $ 30000.00 - $ 35000.00 per annum
Location  Russia - Moscow

 

The leading Global CRO company is looking for an experienced Clinical Trials Specialist for their office in Moscow, Russia.

 

Essential Functions:

 

Conduct and facilitate specific study start-up activities in one or several of the following areas

 

SRP review and approval
ICF review and approval
Study document preparation and collection
Contract preparation and negotiation
Investigator payments
Patient Insurance agreements
Feasibility studies
Study site selection
Investigator database maintenance
Qualification Visit

 

Responsibilities may include one or more of the following items

 

Review and approve investigator site regulatory package documents as defined by effective SOPs and according to applicable local law and study specific guidelines.

 

Review and approve country/site specific ICF

 

Maintain tracking systems on an ongoing basis to ensure that the progress
of regulatory documents can be tracked to meet regulatory and ethics committee deadlines. Provide these status updates as required.

 

Maintain a working knowledge of, and ensure compliance with applicable ICH
Guidelines, Good Clinical Practices, Regulatory Agency.

 

Participate in Regulatory training initiatives, project team meetings (as
appropriate), and maintain relationships with other departments/clients.

 

Perform internal and external feasibilities in close cooperation with the FEG (Feasibility Group) Manager.

 

Identify and qualify potential investigators to assist project teams in expedited study start

 

Check study specific site selection lists against internal DB and perform internet investigation to assure highest quality of selected sites

 

Maintain internal investigator DB on an ongoing basis.

 

Organise process for obtaining translations as required.

 

Support other clinical activities as required to assist with expedited study start up to ensure that the clinical deliverables are met.

 

Assist in the preparation of investigator / client meetings as required.

 

Complete routine administrative tasks in a timely manner (eg. Timesheets, metrics, travel expense claims).

 

Attend staff meetings and training sessions as required to complete the worldwide curriculum in a timely manner.

 

Negotiate Investigational Sites Contracts and Investigators Agreements as defined by effective COG. Handle the study payments related to them as required. Communicate actions between Investigational sites, investigators, clients, team members and the Clinical Research Associates (CRAs) involved in the study to ensure that the timelines are met during the course of the clinical trial.

 

Arrange and track payments related to investigational site contracts

 

Mentor new staff as appropriate.

 

Review qualification reports generated by other CRA's assigned to projects in the region. Highlight common issues and address these with the team as a training need. Raise concerns with the PM/CL or line manager as appropriate

 

Perform co-qualification visits with less experienced CRAs or at problem sites, as required to identify possible areas for training and address these with the local QPTG manager where applicable (depending on level of monitoring experience).

 

Assist with QC/audit of central files and liase with Quality Assurance personnel as required.

 

Qualifications/Skills

 

Degree in a life science, nursing qualification or other relevant experience.
Fluent English in addition to local language
Good written and oral communication skills.
Experience with Microsoft based applications and general knowledge of PC functions. Word-processing, spreadsheet and presentation skills.
Ability to manage multiple and varied tasks with enthusiasm, and prioritise workload with attention to detail.
Willingness to work with multiple supervisors in a matrix environment, and to value the importance of teamwork.
Client focused approach to work.
Able to take initiative and work independently.
Sense of urgency.
Flexibility towards work assignments, new learning and travel as required by the project (may include overnight, weekend and occasional international travel).

 

For further information please contact
Jana Kurtova
Email: jana.kurtova@hayspharma.com

 

Services advertised by Hays Pharma are those of an Agency and/or an Employment Business

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Clinical Trial Updates: Cancer Drugs in Focus as ASCO Approaches

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

 

Cell Therapeutics (CTIC): As previously announced in late February, CTIC is closing its Italian operations starting Monday 5/18 and has reached an agreement with the employee union on a severance package. The agreement relates to a reduction of the Company's total headcount in Italy by 56 positions in the immediate months and is expected to save CTI approximately $14 million in annual operating expenses.

 

CTIC will also present pivotal Phase 3 EXTEND (PIX301) clinical trial data for pixantrone in patients with advanced, relapsed aggressive non-Hodgkin's lymphoma (NHL) at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 29 to June 2, 2009 in Orlando, Florida. Ruth Pettengell, M.D. of St. George's Hospital, University of London, an investigator on the study, is scheduled to present the data on Monday, June 1, 2009 during the Lymphoma and Plasma Cell Disorders session that will be held from 2:00 PM-6:00 PM Eastern Time.

 

CTIC expects to complete the submission of a New Drug Application (NDA) for pixantrone during 2Q09 and will request priority review which, if granted, could lead to an approval decision from the FDA before year-end.

 

CuraGen (CRGN): At the end of 1Q09, CRGN had $80M of cash/investments on hand (with expected cash burn of $3-4M during 2Q09 to fund operations) along with a Phase 2 anti-cancer compound (CR011) that continues to show promising activity in metastatic melanoma and early activity in breast cancer. CRGN has debt of $14M (2011 notes outstanding) and a market cap of just $58M, resulting in a negative enterprise value of ($8M) for the Company.

 

In February, CRGN announced a review of strategic alternatives that could enhance shareholder value, which may result in any or none of the following outcomes: (1) selling or licensing CR011, (2) acquiring additional assets or business lines, or (3) selling the company. CRGN expects to report final results of its Phase 2 melanoma trial and initial results of its breast cancer trial at ASCO. A summary of these trials is provided at this link, which summarizes the Company's most recent SEC 10-Q filing.

 

CR011 is an antibody-drug combination comprised of CR011, a fully-human monoclonal antibody resulting from our collaboration with Amgen (AMGN) Fremont linked to a compound known as monomethylauristatin E, or vcMMAE, using technology licensed from Seattle Genetics (SGEN). CR011 targets a specific molecule located on the surface of cancer cells called glycoprotein NMB, or GPNMB. After the antibody-drug conjugate (CR011-vcMMAE) binds to this target protein, it is transported inside the cancer cell where vcMMAE is separated from the antibody and causes cancer cell death.

 

Allos Therapeutics (ALTH) announced last week that updated data from its pivotal Phase 2 PROPEL study of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma will be presented at ASCO on 5/30/09. The final results from the PROPEL study were reported in early February and formed the basis of the Company's NDA filing for FDA approval in March 2009. The poster presentation at ASCO will include analyses of response rate and durability of response, as well as overall survival.

 

On 5/11/09, Immunomedics (IMMU) provided the following updates for its clinical development pipeline.

 

UCB SA (UCBJF.PK) has completed patient enrollment for their Phase 2b study of epratuzumab in lupus with results expected during 3Q09 calendar year (which is 1Q10 for IMMU fiscal year). The North Central Cancer Treatment Group plans to report final results from its Phase 2 study of epratuzumab with rituximab and chemotherapy in patients with aggressive lymphoma in an ora presentation at ASCO on 5/30/09.

 

Nycomed (privately held) is expected to initiate a Phase 2 study of subcutaneous veltuzumab in patients with rheumatoid arthritis during 3Q09 calendar year (which is 1Q10 for IMMU fiscal year). Data from a Phase 1 study of subcutaneous veltuzumab in B-cell malignancies will be presented in a poster session at ASCO on 6/1/09.

 

Yttrium-90-labeled hPAM4 was granted Fast Track designation for the treatment of patients with pancreatic cancer. Results from Phase 1b study in advanced pancreatic cancer patients will be presented in a poster session at ASCO on 5/31/09. Updated results from the dose-escalation trial of milatuzumab in patients with multiple myeloma will be presented in a poster session at ASCO on 5/30/09.

 

ImmunoGen (IMGN)

 

T-DM1: This TAP compound comprises ImmunoGen's DM1 cell-killing agent linked to the HER2-binding antibody, trastuzumab. It is in development by Roche (RHHBY.PK) through its acquisition of Genentech. Patient enrollment was completed in March 2009 in the Phase 2 trial evaluating T-DM1 as a third-line treatment for HER2-positive metastatic breast cancer. Enrollment in this 100-patient, multi-center study began in July 2008. Genentech expects final study data by 1Q10 and has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the FDA. Final results from the 100-patient "second-line plus" Phase 2 trial for T-DM1 will be reported at the upcoming ASCO annual meeting.

 

IMGN242: This ImmunoGen anticancer compound is in Phase 2 testing for the treatment of CanAg-expressing gastric cancer that failed first-line treatment. Early data from this trial will be reported in an abstract at the ASCO annual meeting and IMGN expects to determine in 2009 whether this study will be expanded or concluded.

 

Roche: Roche recently provided an overview of results from studies that further the Company's approach to developing targeted medicines for people with cancer, a diagnosis that will affect more than one in three people during their lifetime. Results from studies involving the company's approved and investigational treatments will be presented at ASCO. Click here for two video reports associated with this article at BioMedReports.com.

 

   1. Advances in HER2-targeted therapy: Positive Phase 3 study results for Herceptin in advanced HER2-positive stomach cancer and encouraging Phase 2 data in metastatic HER2-positive breast cancer with the novel treatment trastuzumab-DM1 (T-DM1) that uses the Herceptin antibody to deliver a specialised cancer cell-killing agent to tumour cells.
   2. New approaches to treating lung cancer: Positive Phase 3 studies of Avastin and Tarceva as first-line maintenance treatments in advanced non-small cell lung cancer (NSCLC), including important information about biomarkers in lung cancer.
   3. Avastin in early-stage colon cancer: Full results on the first Phase 3 study (C-08).
   4. Personalizing cancer treatment: encouraging early data for Roche's targeted BRAF inhibitor in malignant melanoma.
   5. Combined Roche and Genentech oncology pipeline: includes 27 investigational agents in clinical studies.

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Nevada Cancer Institute talk on clinical trials

Nevada Cancer Institute holds the Cancer Conversations discussion series on cancer, cancer prevention, cancer detection, and survivorship issues. Lectures are in their auditorium at One Breakthrough Way in Las Vegas and run from noon to 1 pm. Lunch is provided. Please arrive by 11:30.

 

May 18: Dr. Kenneth A. Foon, acting director of the Phase I program and head of the Leukemia Section at NVCI, will speak on "Clinical Trials: What They Mean for You or a Loved One."

 

June 24: Dr. Karen Milligan will present "Survivorship: Making It Through the Cancer Journey." Dr. Milligan is a member of the breast cancer oncology team at NVCI and head of NVCI's Survivorship Clinic.

 

August 21: Dr. Kenneth A. Foon will speak about "Leukemia and Lymphoma." Dr. Foon has focused his career on the immunologic/biologic approaches to cancer therapy, concentrating on leukemia and lymphoma.

 

September 30: Medical oncologist and researcher Dr. Oscar B. Goodman's talk will be "Towards the Eradication of Prostate Cancer: A 2009 Update and a Look Ahead." Dr. Goodman, an assistant memberin the Department of Clinical Oncology, sees patients at NVCI with genitourinary cancers, such as prostate and bladder.

 

October 16: Dr. Phillip J. Manno on "Surviving Breast Cancer." Dr. Manno serves as chief of Clinical Oncology and Hematology Services at NVCI.

 

November 18: Dr. Lin-Chi Chen will close the series with "Advances in Lung Cancer Treatment." Dr. Chen is a medical oncologist specializing in thoracic oncology and participates in designing and conducting clinical trials studying novel agents in lung cancer.

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Venus Remedies gets CGI nod for Phase III clinical trials

Venus Remedies has announced that Controller General of India (CGI) has granted permission to conduct Phase III clinical trials on a novel Injectable aminoglycoside to Venus Remedies.

 

The molecule was in-licensed from Chinese Innovator Company by Venus who has the exclusive marketing rights for this product in India.

 

The molecule is a latest generation aminoglycoside in injectable form.

 

The drug is indicated for lower respiratory tract infections like bronchitis, COPD, pneumonia, skin and skin structure infections, sexually transmitted diseases, urinary tract infections, digestive tract infections and surgical infections caused by various pathogens.

 

Intellectual property rights for this product have already been protected. Innovator Company in China has the worldwide patent for this product.

 

Shares of the company closed up Rs 2.50, or 1.47%, at Rs 173. The total volume of shares traded was 110 at the BSE (Friday).

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Reportlinker Adds World Prostate Cancer Therapeutics Market Report

Reportlinker.com announces that a new market research report is available in its catalogue.

 

This report analyzes the worldwide markets for Prostate Cancer Therapeutics in US$ Millions. Analytics in the report specifically focuses on revenues generated from hormonal therapies.The report provides separate comprehensive analytics for US, Europe, and Rest of World. Annual forecasts are provided for each region for the period of 2006 through 2015. The report profiles 138 companies including many key and niche players worldwide such as Abbott Laboratories, AEterna Zentaris Inc., ALZA Corporation, Amgen Inc., AstraZeneca PLC., Medimmune, LLC, Bristol-Myers Squibb Company, Cell Genesys Inc., Dendreon Corporation, EUSA Pharma, (USA) Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., GlaxoSmithKline Plc., Immunomedics, Inc., Indevus Pharmaceuticals Inc., Novartis AG, OSI Pharmaceuticals, Inc., Paladin Labs Inc., Pfizer Inc., Progenics Pharmaceuticals, Inc., Sanofi-Aventis SA, Spectrum Pharmaceuticals, Inc., and Takeda Pharmaceutical Company Limited. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

 

PROSTATE CANCER THERAPEUTICS A GLOBAL STRATEGIC BUSINESS REPORT MCP-1747

 

CONTENTS

 

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

 

Study Reliability and Reporting Limitations I-1 Disclaimers I-2 Data Interpretation & Reporting Level I-2 Product Definitions and Scope of Study I-3 Hormonal Therapy I-3 Radiation Therapy I-4 Chemotherapy I-4 Surgical Procedures I-4 Other Treatment Options I-4

 

II. EXECUTIVE SUMMARY

 

1. Industry Overview II-1 A Prelude II-1 New Products to Bolster Sales of Prostate Cancer Therapeutics II-1 Key Prostate Cancer Drugs & Companies II-2 Hormone Therapies to Dominate Global Prostate Cancer Therapeutics Market II-2

 

Table 1: Sales of FDA Approved Prostate Cancer Hormonal Therapy Drugs in the US for 2007 (includes corresponding Graph/Chart) II-2 Select Prostate Cancer Hormonal Therapy Drugs with Year of FDA Approval II-3 Targeted Therapy - The New Frontier of Cancer Treatment II-3 Radiotherapy - Gaining Prominence II-3 Innovations in Drug Delivery: A Key Factor in Product Differentiation II-4 New Therapies Appear Over the Horizon II-4 New Generation Prostate Cancer Drugs and Their Area of Use II-4 Small Cap Companies: A Target of Private Capital Financing II-5 Drugs (that are both available and under pipeline) Developed by the Three Small-Cap Companies II-5 Minimally Invasive Devices Likely to Get Good Reception in Emerging Markets II-5 Awareness Drives European Prostate Cancer Therapeutics Market II-6 Growth Drivers II-6 Rise in Prostate Cancer Incidences & Access to Modern Therapeutics Foster Growth II-6

 

Table 2: New Incidences of Prostate Cancer (in '000) Worldwide for the years 2004 through 2007 (includes corresponding Graph/Chart) II-6

 

Table 3: New Cancer Cases Diagnosed in the US in 2007: Percentage Share by Leading Cancer Sites (includes corresponding Graph/Chart) II-7 Demographics & Lifestyles Raise the Risk of Prostate Cancer II-7

 

Table 4: Probability of Developing Invasive Prostate Cancer by Age Group in the US (includes corresponding Graph/Chart) II-7

 

Table 5: Male Population by Age Group in the US for the year 2007 (includes corresponding Graph/Chart) II-8 Select General Risk Factors and their Relative Risk Rate in Prostate Cancer II-8 Unmet Needs Leave Scope for Further Research and Development II-8 Supportive Cancer Drugs Contribute to Growth II-8 Select FDA Approved Drugs for Palliative Treatment of Advanced Prostate Cancer II-9 Improved Screening, Diagnosis & Patient Survival Rates Trigger Growth II-9

 

Table 6: Five-Year Prostate Cancer Survival Rate in the US by Race, 1975-2002 (includes corresponding Graph/Chart) II-9

 

Table 7: Five-Year Cancer Survival Rate Among US Males by Type - Prostate and Testis (1996-2002) (includes corresponding Graph/Chart) II-10

 

Table 8: Five-Year Cancer Survival Rate (%) in the US by Race, 1996-2003 (includes corresponding Graph/Chart) II-10 Molecular Imaging of Cancer: Critical in Improving Patient Outcomes II-11 Growth Restraints II-11 Limited Tumor Specificity and Toxicity II-11 Complicated Treatment Protocols: A Major Stumbling Block in Patient Compliance II-11 Multiple Drug Resistance II-12 Stringent Regulations Delay Market Approval II-12 Ongoing Clinical Trials in Hormone Refractory Prostate Cancer II-12 Challenges Encountered in Clinical Trials II-12 Notable Prostate Cancer Drug Failures in Phase III Development II-13 High Development Costs Retracts Manufacturers in Developing Countries II-13

 

2. Clinical Trials II-14 Drugs in Pipeline II-14 Select Prostate Cancer Drugs/Compounds in Pipeline II-14 Select Prostate Cancer Drugs Under Phase II/III Trials by Leading Companies II-15 Drugs in Pre-Clinical Stage II-16 Select Prostate Cancer Drugs/Compounds in Pre-Clinical Stage II-16 Commercially Available Drugs II-16 Select Prostate Cancer Drugs (Commercially Available) by Leading Companies II-16

 

3. Product Overview II-17 Cancer: A Major Health Crises in the Modern World II-17

 

Table 9: Mortality Rate in the US for the Year 2005 by Ailment - Heart Diseases, Cancer, Cerebrovascular Diseases, Chronic Lower Respiratory Diseases, and Accidents (Unintentional Injuries) (includes corresponding Graph/Chart) II-17

 

Table 10: Mortality Rate in the US for the Year 2005: Percentage Breakdown by Cause of Death -Heart Diseases, Cancer, Cerebrovascular diseases, Chronic lower respiratory diseases, Accidents (unintentional injuries), and Others (includes corresponding Graph/Chart) II-17

 

Table 11: Cancer Death Rates in the US (2007): Percentage Breakdown by Cancer Type - Lung & Bronchus, Prostate, Colon & Rectum, Pancreas, Leukemia, and Others (includes corresponding Graph/Chart) II-18

 

Table 12: Comparison of Mortality Among African Americans and Whites by Cancer Type in the US, 2000- 2004 (includes corresponding Graph/Chart) II-18 Prostate - Structure II-18 Pituitary Gland II-19 Testes II-19 Prostate Cancer - A Primer II-20 Key Facts to Gaze at II-20

 

Table 13: Lifetime Probability of Developing Cancer (in Men) by Type in the US, 2002-2004 II-20

 

Table 14: New Incidences of Prostate Cancer (in '000) Worldwide for the years 2007 and 2008 (includes corresponding Graph/Chart) II-21

 

Table 15: Mortality Due to Prostate Cancer (in '000) Worldwide for the Years 2007 and 2008 (includes corresponding Graph/Chart) II-22

 

Table 16: Male Population (in Million) for the Year 2007 for Select Regions (includes corresponding Graph/Chart) II-23 Screening/Detection of Prostate Cancer II-24 Digital Rectal Exam (DRE) II-24 Transrectal Ultrasound (TRUS) II-24 PSA Blood Test II-24 Strategies to Enhance Screening/Detection of Prostate Cancer II-24 Improved PSA Testing II-25 Total PSA, Free PSA and PSA-Alpha-1-Protease Inhibitor Levels II-25 Insulin-like Growth Factor (IGF-1) and Intact IGF- Binding Protien-3 (IGF-BP3) II-25 GSTP1 Methylation Levels and Prostate Cancer Diagnosis II-25 Microbubble Ultrasound II-26 Staging of Prostate Cancer II-26 Gleason Score II-27 Gleason Score and Grading of Prostate Cancer II-27 TNM Staging II-27 T-Staging Analysis of Prostate Cancer II-27 Genetic & Non-Genetic Factors II-28 Hereditary or Genetic Factors II-28 Non-Genetic or Environmental Factors II-28

 

Table 17: Prostate Cancer Incidence/Mortality Rate by Race & Ethnicity in US, 1999-2003 (includes corresponding Graph/Chart) II-29 Prevention of Cancer II-30 Role of Diet in Prostate Cancer II-30

 

4. Treatment Options for Prostate Cancer II-32 Hormonal Therapy II-32 Medical Hormone Therapy II-32 LHRH Analogs II-33 Dose of LHRH Agonists for Advance Prostate Carcinoma Treatment II-33 Anti-Androgens II-34 Leading Non-Steroidal Anti-androgen Hormonal Therapy Drugs for Prostate Cancer II-34 Anti-Androgen Monotherapy II-34 Orchiectomy II-35 Side Effects of Orchiectomy II-35 Time to Start Hormonal Therapy II-35 Strategies to Enhance Hormonal Treatment II-36 Combination Therapy II-36 Intermittent Therapy II-36 Radiation Therapy II-36 Brachytherapy II-36 Treatment Procedure II-37 Benefits of Brachytherapy II-38 Drawbacks of Brachytherapy II-38 High Dose Rate (HDR) Brachytherapy II-39 External Beam Radiation Therapy (EBRT) II-39 Side Effects of Radiotherapy II-39 Strategies to Enhance Radiation Treatment II-39 New Radiation Techniques II-39 Whole Pelvic Radiation Therapy (WPRT) II-40 New Radiation Devices II-40 Chemotherapy II-40 Risks Associated with Chemotherapy II-41 Surgical Procedures for Prostate Cancer II-41 Transurethral Resection of the Prostate (TURP) II-41 Prostatectomy and Lymph Node Dissection II-42 Radical Prostatectomy II-42 Cryosurgery II-43 Advantages of Cryosurgery II-43 Disadvantages of Cryosurgery II-43 Other Treatment Options II-43 Intensity Modulated Radiation Therapy (IMRT) II-43 Benefits of IMRT II-44 Drawbacks of IMRT II-44 Androgen Deprivation Therapy (ADT) II-44 High Dose Radiation (HDR) Monotherapy II-45 Drawbacks of HRD II-45 Choosing the Optimal Treatment Method II-45 Recurrent Prostate Cancer II-46 Recurrent Prostate Cancer Subsequent to Surgery II-46 Recurrent Prostate Cancer Subsequent to Radiation Therapy II-47 Hormone-Refractory Prostate Cancer (HRPC) II-47 Select Drugs in Advanced Development Stage for Hormone- Refractory Prostate Cancer II-47 Chemotherapy II-47 TCaxotere(R) (Docetaxel) II-48 Bone Complication Treatments II-48 Bisphosphonate Drugs II-48 Doxazosin, a Cytotoxic Drug for Prostate Cancer II-49 Radiation Therapy II-49 Strategies to Enhance Recurrent Prostate Cancer Treatment II-49 Chemotherapy - New Regimens II-49 Phase I Clinical Trials II-50 Combination Therapy II-50 Gene Therapy II-50 Targeted Therapy II-50 Selective Endothelia A Receptor Antagonist - (SERA(TM)) II-51 Other Select Targeted Therapies II-52 Tyrosine Kinase Inhibitors II-52 Anti-Angiogenic Drugs II-52 Monoclonal Antibodies II-52 Vaccines II-52 Radioactive Monoclonal Antibodies II-52

 

5. Drug Approvals and Clinical Studies II-53 Debiopharm Unveils Results of Phase III Study of Trelstar in Prostate Cancer Treatment II-53 Algeta to Start Clinical Study of Alpharadin in HRPC II-53 Ferring Receives FDA Approval for Degarelix in Prostate Cancer II-53 Isis and OncoGenex Reveals Positive results of OGX- 011 Molecule in HRPC II-53 Antisoma Completes Phase 2 Study of ASA404 in Prostate Cancer II-53 Cougar Conducts Phase I/II Clinical Trials on CB7630 in Patients with Prostate Cancer II-54 Ambrilia Unveils Results of PCK3145 in Patients with Metastatic Prostate Cancer II-54 Peregrine Pharmaceuticals Reveals Pre-Clinical Data on Bavituximab in Prostate Cancer II-54 Cell Genesys Reveals Data of GVAX Immunotherapy for Treatment of Prostate Cancer II-54 Bioponic Phytoceuticals Unveils Pre-Clinical Data on Curecumin(TM) for Prostate Cancer II-55 New Study Reveals Cough Medicine - Noscapine to be Effective in Prostate Cancer II-55 Fosamax(R) Found Effective in Preventing Bone Loss in Prostate Cancer Patients II-55 Genta Unveils Results of Phase II Clinical Trial of Genasense(R) in Prostate Cancer II-55 Cell Therapeutics Reveals Phase 2 Clinical Trial Results of XYOTAX(TM) in Androgen Independent Prostate Cancer Patients II-56 Sanofi-Aventis' Taxotere(R) Enhances Survival in Metastatic Prostate Cancer Patients II-56 NCI Initiates Phase 2 Clinical Trial of Cytogen's QUADRAMET for HRPC II-56 Cleveland BioLabs to Initiate Phase II Clinical Trial for Curaxin in HRPC II-57 NeoRx Begins Clinical Study for Picoplatin in Prostate Cancer II-57 Novacea Starts Phase III Clinical Trial for Treatment of Prostate Cancer II-57 Next Pharmaceuticals' Supplement Nexrutine Help Prevent Prostate Cancer II-57 Antisoma Reveals Results from AS1404 Phase II Clinical Trial in HRPC II-57 Marshall Edwards Conducts Study on Phenoxodiol in Prostate Cancer II-58 Combination of Provenge(R) and Taxotere(R) Offer Better Results for HRPC Patients II-58 Ambrilia Reveals Results of PSP-94 Immunoassay Study for Cancer Therapy II-58 University of California's Analyses Support Dendreon's Active Cellular Immunotherapy II-59 Spectrum Announces Positive Outcome of Satraplatin Trial on HRPC Patients II-59 Panacea Pharmaceuticals Identifies Blood Protein for Early Prostate Cancer Detection II-60 Active Biotech Reveals Results of TASQ Phase I Study for Prostate Cancer II-61 Positive Results of Combined Hormone and Radiation Therapies in Locally Advanced Prostate Cancer II-61 Positive Results from Use of IMRT in Localized Prostate Cancer II-61 Balanced Intake of Omega-6 and Omega-3 Fatty Acids Found to Reduce Prostate Cancer Growth II-62 Sanofi's Taxotere Gains Approval from Nice of UK for Use in Late-Stage Prostate Cancer II-62 Protox Gains Clearance from FDA to Conduct Phase I Trial of PRX302 II-63 AEterna Zentaris's Ozarelix Phase II Trial Shows Positive Results II-63 Biomira Announces Results of Stimuvax Phase 2 Clinical Study II-64 Cytogen Receives FDA Clearance for CYT-500 IND Application II-64 US Researchers Unveils New Therapeutic Cancer Vaccine For Metastatic Prostate Cancer II-64 PNNL and IsoRay Develops Cesium-131 Seed for Treatment of Prostate Cancer II-65

 

6. Product Innovations/Introductions II-66 Speciality European Pharma Introduces Plenaxis II-66 Actavis Unveils Bicalutamide Tablets for Prostate Cancer in the European Markets II-66 Artemis to Introduce IGRT II-66 Immunomedics Introduces Immunotoxin for Treatment of Prostate and Lung Cancer II-66 Barr Unveils Generic Version of Proscar(R) Tablets II-67 IRX Therapeutics to Develop Vaccine for Prostate Cancer II-67 Actavis Introduces New Generic Drugs in Europe II-67 Robot-Assisted Radical Prostatectomy for Treatment of Prostate Cancer II-67

 

7. Recent Industry Activity II-68 Sanofi-Aventis Secures Approval of Japanese Health Ministry for Taxotere(R) Injection II-68 Schering-Plough Terminates Collaboration with Novacea II-68 Takeda Terminates JV Deal, Merges its Subsidiaries II-68 Aureon Laboratories and Pfizer Announce Research Partnership II-68 Celera Enters into Licensing Agreement with Merck II-69 Celera Announces Demerger from Applera Corporation II-69 GPC Biotech and Celgene Terminate Agreement for Satraplatin II-70 EUSA Acquires Cytogen Corporation II-70 Eisai Acquires MGI Pharma II-70 BN ImmunoTherapeutics Enters into a Scientific Partnership with NCI II-70 Morphotek(R) Enters into Licensing Agreement with NCI II-71 ValiRx Acquires Exclusive Evaluation License from CRT for New Prostate Cancer Compound II-71 Cell Genesys Forms Global Alliance with Takeda on GVAX Immunotherapy Development for Prostate Cancer II-71 Sirnaomics Extends Partnership with GRL to Develop Multi- Targeted RNAi Therapeutic Products II-72 Aureon and Pfizer to Collaborate on New Stage of Research Project II-72 CancerPartners UK Collaborates with Spire Healthcare II-72 Cougar Biotech Enters into an Agreement with US FDA II-73 Scottish Scientists Receives Contract from Cancer Research UK II-73 ValiRx Collaborates with University of Surrey on Prostate Cancer Diagnostics II-73 ValiRx Subsidiary Extends Collaboration with Cancer Research Technology II-73 MacroArray Partners with Abbott on PCADM-1 Test for Prostate Cancer II-74 Novacea Enters into Agreement with Schering-Plough II-74 Bayer to Stop Sale of Viadur - A Drug for Prostate Cancer II-74 Sagemark Embarks on Radiation Therapy Venture II-75 RTS Concludes Californian Radiation Therapy Center Acquisition II-75 Radiation Therapy Takes Over a North Carolina Treatment Center II-75 DRAXIMAGE and Med Discovery Enter into Research Collaboration II-75 Core Oncology Completes Acquisition of Coloplast's Brachytherapy Business II-76 Novacea Licenses Asenstar Prostate Cancer Drug to Schering-Plough II-76 Bentley Receives Approval for Generic Version of Casodex II-76 GSK Acquires Praecis Pharmaceuticals II-77 Samaritan Acquires Metastatin Pharma II-77 Champions Biotechnology Acquires Patent Rights for Potential Cancer Treatments II-77 GPC Biotech Submits NDA for Treatment of Prostate Cancer II-77 MedMira Inks Agreement to Take Over Rights of a New Marker Technology II-78 Cell Genesys's GVAX Prostate Cancer-Treatment Attains FDA's Fast Track Tag II-78 Envisioneering Medical Enters into Agreement with BrachySciences II-78 Signet Enters into Agreement with AsymmetRx to Distribute ' Prostate-63' Tests II-79 Mylan Pharmaceuticals Obtains FDA Approval for Finasteride's ANDA II-79 AEterna Zentaris Enters into Agreement with Nippon Kayaku II-79 Progenics Pharmaceuticals Broadens Association with Seattle Genetics II-80 Diosynth and Dendreon Sign Multi-Year Commercial Supply Deal II-80 Genstar Capital Completes Acquisition of OnCure II-80 Generex Biotechnology Expands Antigen Express Cancer Trials II-80 Progenics Pharmaceuticals Acquires PSMA Development Company II-81 Schweizerhall Acquires Novosis II-81 Misonix Expands into France with Sonablate(R) 500 II-81 Indevus Enters into Agreement to Takeover Valera II-82 Oncobionic Receives FDA Clearance for Cancer Treatment Technology II-82 Misonix Expands HIFU Business in Europe by Entering into Spain II-82 Altana Divests Entire Stake in GPC Biotech II-83 Ipsen Enters into Partnership with GTx to Develop and Market Acapodene in Europe II-83 Egenix and Proteome Systems Collaborate to Develop Prostate Cancer Test Using Semen II-83 Valera and Spepharm Partner to Market Vantas, and Supprelin-LA II-84 SurModics and AbbeyMoor Collaborate to Develop Products to Treat Prostate Diseases II-84 Dendreon Constructs Manufacturing Facility in New Jersey II-84 MediGene Introduces Prostate Cancer Drug in Italian Market II-85 Gen-Probe Introduces Innovative Test for Prostate Cancer in Europe II-85 DRL Introduces Generic Version of Proscar II-85 Ferring Partners with Astellas on Degarelix License for Prostate Cancer Treatment II-85 Protox Acquires PRX321 Cancer Program from US Public Health Service and Neurocrine II-86 Astex Collaborates with CRT and Newcastle University for New Drug Discovery II-86 Miraculins and Duke University Enter into Collaboration II-86 Bayer Receives Rights to Prostate Cancer and Transplantation Drug Test from Abbott II-86 Encorium Group Signs Contract with Global Biopharmaceutical Company II-86 Paladin Signs an Agreement with Watson for Supply and Sale of Trelstar(R) II-87 BioWa Obtains License for Anti-FGF8 Antibody from Kyowa Hakko II-87 OncoGenex and Isis Pharmaceuticals Expand Partnership II-87 Caprion and AstraZ eneca Enter into Collaboration II-88 Innovate Oncology and Prostagenics Enter into Capridine- Beta Development Agreement II-88 Protein Design Labs Sublicenses Antibody-Drug Conjugates Development Rights to Genentech II-88 National Cancer Institute Enters into Agreement with Illumina II-89 Sosei Seeks Marketing Rights for Prostate Cancer Drug in Japan II-89

 

8. Focus on Select Global Players II-90 Abbott Laboratories (USA) II-90 AEterna Zentaris Inc. II-90 ALZA Corporation (USA) II-90 Amgen Inc. (USA) II-91 AstraZeneca PLC (UK) II-91 Medimmune, LLC (USA) II-92 Bristol-Myers Squibb Company (USA) II-92 Cell Genesys Inc. (USA) II-92 Dendreon Corporation (USA) II-93 EUSA Pharma, (USA) Inc. (USA) II-93 F. Hoffmann-La Roche Ltd. (Switzerland) II-94 Genentech Inc. (USA) II-94 GlaxoSmithKline Plc (UK) II-95 Immunomedics, Inc. (USA) II-95 Indevus Pharmaceuticals Inc. (USA) II-95 Novartis AG (Switzerland) II-96 OSI Pharmaceuticals, Inc. (USA) II-96 Paladin Labs Inc. (Canada) II-97 Pfizer Inc. (USA) II-97 Progenics Pharmaceuticals, Inc. (USA) II-97 Sanofi-Aventis SA (France) II-98 Spectrum Pharmaceuticals, Inc. (USA) II-98 Takeda Pharmaceutical Company Limited (Japan) II-98

 

9. Global Market Perspective II-100

 

Table 18: World Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics by Geographic Region/ Country - US, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) II-100

 

Table 19: World 10-Year Perspective for Prostate Cancer Therapeutics by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Europe, and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart) II-101

 

III. MARKET

 

1. The United States III-1 A.Market Analysis III-1 Overview III-1 A Surging US Prostate Cancer Therapeutics Market III-1

 

Table 20: Probability of Developing Invasive Prostate Cancer by Age Group in the US (includes corresponding Graph/Chart) III-1

 

Table 21: Male Population by Age Group in the US for the Year 2007 (includes corresponding Graph/Chart) III-2 Cost of Cancer Drugs - A Major Concern in the US III-2 Market Accelerators III-2 Market Challenges III-3 Market Inhibitors III-3

 

Table 22: Sales of FDA Approved Prostate Cancer Hormonal Therapy Drugs in the US for 2007 (includes corresponding Graph/Chart) III-3 Current and Future Analysis III-3 Key Statistics III-4

 

Table 23: Mortality Rate in the US for the Year 2005 by Ailment - Heart Diseases, Cancer, Cerebrovascular Diseases, Chronic Lower Respiratory Diseases, and Accidents (Unintentional Injuries) (includes corresponding Graph/Chart) III-4

 

Table 24: Mortality Rate in the US for the Year 2005: Percentage Breakdown by Cause of Death -Heart Diseases, Cancer, Cerebrovascular diseases, Chronic lower respiratory diseases, Accidents (unintentional injuries), and Others (includes corresponding Graph/Chart) III-4

 

Table 25: Cancer Death Rates in the US (2007): Percentage Breakdown by Cancer Type - Lung & Bronchus, Prostate, Colon & Rectum, Pancreas, Leukemia, and Others (includes corresponding Graph/Chart) III-4

 

Table 26: New Cancer Cases Diagnosed in the US in 2007: Percentage Share by Leading Cancer Sites (includes corresponding Graph/Chart) III-5

 

Table 27: New Cases of Prostate Cancer Diagnosed in the US: Breakdown by Leading States for the Years 2007 and 2008 (includes corresponding Graph/Chart) III-5

 

Table 28: Mortality Due to Prostate Cancer in the US: Breakdown by Leading States for the Years 2007 and 2008 (includes corresponding Graph/Chart) III-6

 

Table 29: Lifetime Probability of Developing Cancer (in Men) by Type in the US, 2002-2004 III-6

 

Table 30: Comparison of Mortality Among African Americans and Whites by Cancer Type in the US, 2000-2004 (includes corresponding Graph/Chart) III-7

 

Table 31: Five-Year Prostate Cancer Survival Rate in the US by Race, 1975-2002 (includes corresponding Graph/Chart) III-7

 

Table 32: Five-Year Cancer Survival Rate Among US Males by Type - Prostate and Testis (1996-2002) (includes corresponding Graph/Chart) III-8

 

Table 33: Five-Year Cancer Survival Rate (%) in the US by Race, 1996-2003 (includes corresponding Graph/Chart) III-8

 

Table 34: Prostate Cancer Incidence/Mortality Rate by Race & Ethnicity in US, 1999-2003 (includes corresponding Graph/Chart) III-9 Clinical Trials III-9 Product Launches III-19 Strategic Corporate Developments III-19 Select Players III-32 B.Market Analytics III-41

 

Table 35: US Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-41

 

2. Europe III-42 A.Market Analysis III-42 Overview III-42 Awareness Drives European Prostate Cancer Therapeutics Market III-42

 

Table 36: New Cases of Prostate Cancer Diagnosed in Europe: Breakdown by Region/Country for the Years 2007 and 2008 (In '000) (includes corresponding Graph/Chart) III-42

 

Table 37: Mortality Due to Prostate Cancer in Europe: Breakdown by Region/ Country for the Years 2007 and 2008 (In '000) (includes corresponding Graph/Chart) III-43 Current and Future Analysis III-43 Clinical Trial III-43 Product Launches III-44 Strategic Corporate Developments III-44 B.Market Analytics III-46

 

Table 38: European Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics by Geographic Region/Country - France, Germany, Italy, United Kingdom, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-46

 

Table 39: European 10-Year Perspective for Prostate Cancer Therapeutics by Geographic Region/Country - Percentage Breakdown of Dollar Sales for France, Germany, Italy, United Kingdom, Spain, and Rest of Europe Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart) III-47

 

2a. France III-48 A.Market Analysis III-48 Overview III-48 Anti-Androgen and LHRH Analogs Drive the French Market III-48 Current and Future Analysis III-48 Clinical Trials III-48 Strategic Corporate Developments III-49 Select Players III-50 B.Market Analytics III-51

 

Table 40: French Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-51

 

2b. Germany III-52 A.Market Analysis III-52 Current and Future Analysis III-52 Product Launch III-52 Strategic Corporate Developments III-52 GPC Biotech AG - A Major Player III-54 B.Market Analytics III-54

 

Table 41: German Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-54

 

2c. Italy III-55 A.Market Analysis III-55 Italian Prostate Cancer Therapeutics Market - An Overview III-55 Current and Future Analysis III-55 Clinical Trial III-55 Strategic Corporate Development III-55 B.Market Analytics III-56

 

Table 42: Italian Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-56

 

2d. The United Kingdom III-57 A.Market Analysis III-57 Overview III-57 LHRH Analogs - The Market Driver III-57 Current and Future Analysis III-57 Clinical Trials III-57 Product Launch III-58 Strategic Corporate Developments III-58 Select Players III-60 B.Market Analytics III-62

 

Table 43: UK Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-62

 

2e. Spain III-63 A.Market Analysis III-63 Overview III-63 Spanish Prostate Cancer Therapeutics Market - On a Roll III-63 Current and Future Analysis III-63 Strategic Corporate Developments III-63 B.Market Analytics III-64

 

Table 44: Spanish Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-64

 

2f. Rest of Europe III-65 A.Market Analysis III-65 Current and Future Analysis III-65 Clinical Trials III-65 Strategic Corporate Development III-65 Select Players III-66 B.Market Analytics III-67

 

Table 45: Rest of Europe Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-67

 

3. Rest of World III-68 A.Market Analysis III-68 Current and Future Analysis III-68 A Peek into Canadian Market III-68

 

Table 46: New Cases of Prostate Cancer Diagnosed in Canada (2008): Breakdown by Leading Province (includes corresponding Graph/Chart) III-68

 

Table 47: Mortality Due to Prostate Cancer Diagnosed in Canada (2008): Breakdown by Leading Province (includes corresponding Graph/Chart) III-68

 

Table 48: Prostate Cancer Market in Canada (2008): New Cases and Deaths Due to Prostate Cancer by Age Group III-69 Ambrilia Unveils Results of PCK3145 in Patients with Metastatic Prostate Cancer III-69 Ambrilia Reveals Results of PSP-94 Immunoassay Study for Cancer Therapy III-69 Select Canadian Players III-70 A Glance into Other Select Markets III-71 Minimally Invasive Devices Likely to Get Good Reception in Emerging Markets III-71 Cancer Market in Asia III-72 Australia III-72 India III-72 Japan III-72 Malaysia III-73

 

Table 49: New Cases of Prostate Cancer Diagnosed in Asia-Pacific: Breakdown by Region/Country for the Years 2007 and 2008 (includes corresponding Graph/Chart) III-73

 

Table 50: Mortality Due to Prostate Cancer in Asia-Pacific: Breakdown by Region/ Country for the Years 2007 and 2008 (includes corresponding Graph/Chart) III-73 Cancer Market in Latin America III-74 Brazil III-74 Mexico III-74 Argentina III-74

 

Table 51: New Cases of Prostate Cancer Diagnosed in Latin America: Breakdown by Region/Country for the Years 2007 and 2008 (includes corresponding Graph/Chart) III-74

 

Table 52: Mortality Due to Prostate Cancer in Latin America: Breakdown by Region/ Country for the Years 2007 and 2008 (includes corresponding Graph/Chart) III-75 Clinical Trial III-75 Product Launch III-75 Strategic Corporate Developments III-76 Select Players III-78 B.Market Analytics III-79

 

Table 53: Rest of World Recent Past, Current & Future Analysis for Prostate Cancer Therapeutics Market with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart) III-79

 

World Prostate Cancer Therapeutics Market

 

http://www.reportlinker.com/p0119471/World-Prostate-Cancer-Therapeutics-Market.html

 

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MedSource Awarded Services Contract for a Phase III Epilepsy Clinical Trial

MedSource, a Contract Research Organization (CRO) providing Phase I-IV clinical trials support, announced it has been awarded a service contract to manage a 50-center, multi-national, late phase epilepsy trial. The Houston-based CRO with regional offices in Raleigh, NC, will provide Project Management, Clinical and Regulatory services for the Phase III randomized, double-blind, placebo-controlled, cross-over trial.

 

"This award represents our client's satisfaction with our previous work and is seen as a vote of confidence in our continued abilities and expertise. It further solidifies our commitment to expand and deepen our Central Nervous System and epilepsy trial experience as well as our relationship with the Epilepsy Consortium," stated Eric Lund, President of MedSource.

 

"It is our intent to work toward establishing MedSource as a leader in this space," added Lund.

 

MedSource specializes in complex diseases and study designs and has experience in more than 400 trials in Phases I-IV. For more information, visit http://www.medsource.com.

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Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection

Positive data from subgroup analysis presented at 19th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Helsinki, Finland

 

SAN DIEGO, May 17 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced that the results from its North American Phase 3 clinical study of fidaxomicin in patients with Clostridium difficile infection (CDI) were presented today by clinical investigator Thomas J. Louie, M.D. for the first time in an oral presentation at the 19th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Helsinki, Finland.

 

Dr. Louie presented the positive top-line results that the Company had previously announced in November 2008. The trial met its primary endpoint with fidaxomicin achieving clinical cure compared to Vancocin(R). In addition, patients treated with fidaxomicin experienced a reduction in CDI recurrence compared to Vancocin (p=0.004) and had a higher global cure (cure with no recurrence within four weeks) compared to Vancocin (p=0.006).

 

"This study showed that fidaxomicin is as effective as vancomycin for treatment of C. Difficile diarrhea, including treatment of infection by the hyper virulent NAP1/ribotype 027 outbreak strain. Moreover, compared to vancomycin, recurrence of CDI is significantly less likely to occur following fidaxomicin therapy. Combining cure of CDI and freedom from recurrence, fidaxomicin is superior to vancomycin as treatment for this serious and common cause of infectious diarrhea," said Thomas J. Louie, M.D., Medical Director, Infection Prevention and Control for the Calgary Health Region and professor in the Departments of Medicine and Microbiology-Infectious Diseases, University of Calgary. "These findings indicate that fidaxomicin offers both highly effective but more selective therapy that is less damaging to the normal intestinal bacteria that protect against recurrence of CDI."

 

Additional findings also presented for the first time include a subgroup analysis of clinical cure and recurrence rates for fidaxomicin compared to Vancocin, as well as baseline demographic and disease characteristics. Clinical cure rates for fidaxomicin and Vancocin were similar in each of the following subgroups: patient status (in-patient/out-patient), age (under/over 65) and strain type (BI/NAP1/027). Most notably, fidaxomicin showed a reduction across several subgroups in recurrence rates compared to Vancocin in both out-patient and in-patient settings, as well as in patients both over and under the age of 65. The recurrence rates in the BI/NAP1/027 subgroup were similar between fidaxomicin and Vancocin.

 

    Per Protocol                          Fidaxomicin     Vancocin(R) capsules
    (microbiologically evaluable)         (200mg bid)         (125mg qid)

 

    Recurrence Rates by Subgroup
    Patient Status
      In-patient                          17.9% (19/106)      26.1% (29/111)
      Out-patient                          8.6% (9/105)       21.8% (24/110)

 

    Age
      < 65                                 9.5% (12/126)      18.6% (22/118)
      >/= 65                              18.8% (16/85)       30.1% (31/103)

 

    Strain Type
     BI (NAP1/027)                        25.0% (11/44)       24.1% (13/54)
    Overall                               13.3% (28/211)      24.0% (53/221)

 

Baseline demographic and disease characteristics of study participants were similar between the fidaxomicin and Vancocin arms. The BI/NAP1/027 hyper virulent strain of C. difficile was present in 36% of patients in the study. 46% of the patients were over the age of 65, 56% were in-patients, 17% had a prior episode of CDI and study participants had an average of 8.3 bowel movements per day.

 

The incidence of adverse events and serious adverse events between the fidaxomicin and Vancocin arms was similar.

 

Additional detailed data from the study will be presented at medical conferences throughout the year.

 

Fidaxomicin Clinical Study Design

 

629 adult subjects were enrolled in this multi-center, randomized, double-blind Phase 3 clinical trial, which was the largest such trial for the treatment of CDI. Subjects with confirmed CDI received either 200 mg fidaxomicin dosed orally twice daily or 125 mg Vancocin dosed orally four times daily. This study was conducted in more than 100 clinical sites throughout North America. The objective of the study was to show that a 10-day course of fidaxomicin was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI.

 

The primary endpoint of the study was clinical cure defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator. The secondary endpoint evaluated CDI recurrence up to four weeks post therapy with recurrence defined as the return of diarrhea associated with CDI confirmed by a positive toxin test. Global cure was defined as patients who were cured and did not have a recurrence.

 

About Clostridium Difficile Infection

 

CDI has become a growing problem in hospitals, long-term care facilities and in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. CDI typically develops from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, allowing C. difficile bacteria to flourish.

 

Current therapeutic options for CDI include metronidazole and oral vancomycin. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration.

 

Primary risk factors for CDI include broad-spectrum antibiotic use, advanced age (over 65), emerging hyper-virulent strains (NAP1/027, 078, 001) of C. difficile, and previous exposure to CDI that lead to recurrence. Higher incidence, increased treatment failures, and recurrence with standard therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials.

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Johns Hopkins University signs deal with Clinical Trials & Surveys to use its management software

Clinical Trials & Surveys Corp. has signed a deal with Johns Hopkins University to provide software to manage clinical data for a Phase 1 trial for a new vaccine.

 

The Baltimore company's $50,000 contract enables the university to replace paper with an electronic system to recod information in its clinical trial process. The company declined to name the vaccine, as it was a confidential piece of the contract.

 

The software company's clients include private companies, universities and government agencies. Clients include the National Institute of Allergy & Infectious Diseases and Columbia University.

 

Its products aid research in cancer, cardiovascular disease, AIDS and pulmonary disease.

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Immunotherapy Effective Against Neuroblastoma In Children

A phase III study has shown that adding an antibody-based therapy that harnesses the body's immune system resulted in a 20 percent increase in the number of children living disease-free for at least two years with neuroblastoma. Neuroblastoma, a hard-to-treat cancer arising from nervous system cells, is responsible for 15 percent of cancer-related deaths in children.

 

The researchers reported their findings – the first to show that immunotherapy could be effective against childhood cancer – online May 14, 2009 on the American Society of Clinical Oncology website in advance of presentation June 2.

 

"This establishes a new standard of care for a traditionally very difficult cancer in children," said lead author Alice Yu, MD, PhD, professor of pediatric hematology/oncology at the University of California, San Diego School of Medicine and the Moores UCSD Cancer Center. "High-risk neuroblastoma has always been a frustrating cancer to treat because, despite aggressive therapy, it has a high relapse rate."

 

The therapy targets a specific glycan (a complex sugar chain found on the surface of cells) on neuroblastoma cells called GD2, which inhibit the immune system from killing cancer cells. The antibody – ch14.18 – binds to this glycan, enabling various types of immune cells to attack the cancer.

 

Neuroblastoma – in which the cancer cells arise from nerve cells in the neck, chest, or abdomen – is the most common cancer diagnosed in the first year of life. Approximately 650 new cases of neuroblastoma are diagnosed in this country every year, and about 40 percent of patients have high-risk neuroblastoma. These high-risk patients are usually treated with surgery, intensive chemotherapy with stem cell rescue (in which patients' adult stem cells, removed before treatment, are returned after chemotherapy to restore the blood and immune system), and radiation therapy. Still, only 30 percent of patients survive.

 

Yu and her colleagues compared both the percentage of patients who were still alive without experiencing a recurrence after two years as well as overall survival in two groups of 113 patients each. Patients began the trial when they were newly diagnosed with high-risk neuroblastoma. After conventional treatment with surgery, chemotherapy, stem cell rescue and radiotherapy, one group was given the standard treatment (retinoic acid) plus immunotherapy (the antibody plus immune-boosting substances), while 113 similar patients received the standard treatment alone.

 

After two years, 66 percent of individuals in the immunotherapy group were living free of cancer compared to 46 percent in the standard treatment group. Overall survival improved significantly as well. The trial patient randomization was halted early because of the benefit seen, and all patients enrolled in the trial will receive immunotherapy plus standard treatment.

 

Yu noted that the two-year mark is especially important because past trials have shown that those neuroblastoma patients who live without disease for two years after a stem cell transplant will most likely be cured.

 

"This is the first time in many years that we have been able to improve the 'cure rate' for neuroblastoma patients," she said. "This new therapy can help us improve care and perhaps offer new hope to many patients and families."

 

Yu and her team conducted the early phase I and phase II trials at the General Clinical Research Center at UC San Diego Medical Center.

 

Other co-authors include Andrew Gilman, Carolinas Medical Centre; M. Fevzi Ozkaynak, New York Medical College; Susan Cohn, University of Chicago; John Maris, Children's Hospital of Philadelphia; Paul Sondel, University of Wisconsin; W. B. London, University of Florida; S. Kreissman, Duke University; H.X. Chen, National Cancer Institute; and K.K. Matthay, UCSD. Local patients were seen in San Diego at Rady Children's Hospital.

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Clinical trials available for dogs with idiopathic seizures

A clinical trial to evaluate new medication for idiopathic epilepsy in dogs is being conducted in several cities nationwide through the end of this year, with veterinary neurology specialists participating.

 

Regulated by the Food and Drug Administration (FDA) and sponsored by a major animal-health pharmaceutical firm, the trial offers qualifying dogs referred by their veterinarians free medical evaluations and diagnostic tests, which may include CAT scans or MRIs, and free medication and monthly exams. Owners can have funds credited to their accounts at their referring veterinarians.

 

Dogs must be evaluated by an investigator within seven days of the most recent seizure. Potential risks and benefits of the medication will be discussed with owners prior to enrollment.

 

Trials currently are being conducted in Alabama, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, Missouri, Oklahoma, Pennsylvania, South Carolina, Tennessee and Texas. Other states may be added later.

 

Idiopathic epilepsy affects about four million dogs in the United States, about 5.7 percent of the dog population. Breeds most susceptible include Beagles, Belgian Tervurens, Bernese Mountain Dogs, British Alsatians, Collies, Dachshunds, German Shepherds, Golden Retrievers, Keeshondens, Labrador Retrievers, Miniature Schnauzers, Portuguese Water Dogs and Vizslas.

 

To qualfy for the trial, dogs must be at least 4 months old, not previously treated with anti-seizure medication, weigh at least 11 pounds, not pregnant and have no previous history of seizure clusters or status epilepticus.

 

Raleigh-based Visionaire Research & Education, which helps veterinary pharmaceutical firms recruit for clinical trials, is helping coordinate the trials.

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BioVex to Report Phase I/II Clinical Trial Results for the Front Line Treatment of Head and Neck Cancer With OncoVEX GM-CSF at the 2009 American Society of Clinical Oncology Meeting

BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced today that the results from a Phase I/II combination study in previously untreated patients with head and neck cancer will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 29, 2009 - June 2, 2009 in Orlando, FL.

 

The results are to be presented in an abstract (number 6018) entitled, "Phase I/II dose escalation study of OncoVEX GM-CSF and chemoradiotherapy (CRT) in untreated stage III/IV squamous cell cancer of the head and neck (SCCHN)," at a poster session on Friday, May 29, 2009 from 2:00pm - 6:00pm EDT on Level 2, West Hall F3 of the conference. A poster discussion will take place from 5:00pm - 6:00pm EDT.

 

Study Rationale

 

Patients with head and neck cancer often present with bulky disease that is too large or too close to vital organs for surgical removal. These patients typically undergo radiation and chemotherapy treatment prior to surgery. Patients who present with tumor containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years.

 

In this study, OncoVEX GM-CSF was administered by direct injection, at three dose levels, into tumor containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles. All patients then went for surgery. Of the 17 Stage III/IVA (N1-3) patients treated, 16 had N2 or N3 disease.

 

Study Results

 

The abstract, now available online at www.asco.org, reports that OncoVEX GM-CSF was well tolerated, with no significant additional side effects noted over and above those which are common with chemoradiation alone. With respect to efficacy, 94% of patients had a complete pathological response noted at surgery, with five patients achieving a complete response after only 2 or 3 viral doses. No patient has recurred locally in the neck at a median follow up of 26 months at the time of abstract submission. Three patients had distant metastatic disease. Two of these were in the low dose group. One additional low dose patient developed a new primary tumor post treatment. OncoVEX GM-CSF was detected in injected and adjacent uninjected tumors at a therapeutic dose.

 

Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said:

 

"Loco-regional control is extremely important in head and neck cancer where loco regional progression is responsible for the majority of deaths. The two year loco-regional failure rate following front line treatment is around 30% with a further 20% of patients progressing at a distant site. The long term loco-regional control rate of 100% combined with the very high percentage of patients in the mid and high dose groups that remain disease free at up to 36 months from treatment is very encouraging. As a result, OncoVEX GM-CSF clearly warrants further investigation in this setting."

 

Philip Astley-Sparke, President & CEO, for BioVex said:

 

"We are encouraged by these results which echo results in other studies using OncoVEX GM-CSF as a stand alone therapy where it remains the case that no tumor previously eradicated through OncoVEX GM-CSF therapy has been known to recur. The study reported here has demonstrated that combining OncoVEX GM-CSF with standard cancer therapies may also provide clinical benefit. Combinations involving OncoVEX GM-CSF may also allow less aggressive chemo radiation regimens to be employed whilst maintaining similar or better clinical outcomes as compared to more debilitating regimens. Following on from the ongoing pivotal Phase III study in melanoma, we plan to submit a second Phase III protocol in head and neck cancer to the FDA under the SPA procedure this summer."

 

About Head and Neck Cancer

 

Head and neck cancer accounts for 47,000 new cases (3% of all new cancer cases and 2% of all cancer deaths) in the United States annually. It is the fifth most common malignancy worldwide , or an estimated 644,000 new cases annually.

 

Patients with locally advanced tumors are best treated with concurrent chemo radiation, with planned neck dissection indicated in certain patients. Despite aggressive treatment of locally advanced disease loco regional recurrences develop in 30% of patients, distant metastases in 20%. Aggressive combined modality therapy may be frequently associated with debility, and numerous physical and psychological symptoms including pain, dysphagia, weight loss, disfigurement, depression, and xerostomia (dry mouth). As a result, new and improved, and less toxic therapies for head and neck cancer are urgently required.

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Proteolix to Present Carfilzomib Clinical Data During the 2009 ASCO Annual Meeting

Results from Phase 2 Clinical Trials of Carfilzomib in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Featured in Oral Presentations

 

Proteolix, Inc. today announced that data from clinical trials of carfilzomib in multiple myeloma and advanced solid tumors will be presented at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 29 - June 2, 2009 in Orlando, Florida. Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors and is currently enrolling patients in an accelerated approval study in relapsed/refractory multiple myeloma and Phase 2 clinical studies in relapsed multiple myeloma and other malignancies.

 

Of note, results from Proteolix's Phase 2 study of carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma will be presented on Monday, June 1 during an oral session by Sundar Jagannath, M.D., Chief of the Multiple Myeloma Program, Bone Marrow and Blood Stem Cell Transplantation at St. Vincent's Comprehensive Cancer Center in New York. The Phase 2 trial is an open-label multi-center study of single-agent carfilzomib in patients who have previously failed at least two prior treatments, containing bortezomib and either lenalidomide or thalidomide, and are refractory to their last treatment. In addition, results from a Phase Ib/II study of carfilzomib in patients with selected advanced metastatic solid tumors will be presented on Saturday, May 30 during an oral session by Peter Rosen, M.D., Medical Director, Tower Cancer Research Foundation and Emeritus Professor, UCLA.

 

A complete list of the company's oral and poster presentations at ASCO follows:

 

    Oral Presentations
      Saturday, May 30, 2009 at 5:00 p.m. ET
      Track: Developmental Therapeutics
      Session: Developmental Therapeutics: Molecular Therapeutics
      Location: Level 4, Valencia Room, W415A
        --  Phase II results of Study PX-171-007: A Phase Ib/II study of
            carfilzomib (CFZ), a selective proteasome inhibitor, in patients
            with selected advanced metastatic solid tumors. (Abstract #3515)

 

      Monday, June 1, 2009 at 3:45 p.m. ET
      Track: Developmental Therapeutics, Lymphoma and Plasma Cell Disorders
      Session: New Agents for Multiple Myeloma
      Location: Level 2, West Hall F1
        --  Final results of PX-171-003-A0, part 1 of an open-label, single-
            arm, Phase II study of carfilzomib (CFZ) in patients (pts) with
            relapsed and refractory multiple myeloma (MM). (Abstract #8504)

 

    Poster Presentations
      Monday, June 1, 2009 from 2:00 p.m. to 6:00 p.m. ET
      Track: Lymphoma and Plasma Cell Disorders
      Session: Lymphoma and Plasma Cell Disorders
      Location:  Level 2, W240A
        --  PX-171-004, a multicenter Phase II study of carfilzomib (CFZ) in
            patients with relapsed myeloma: An efficacy update. (Abstract
            #8537)

 

        --  PX-171-006: Phase Ib multicenter dose escalation study of
            carfilzomib (CFZ) plus lenalidomide (LEN) and low-dose
            dexamethasone (loDex) in relapsed and refractory multiple myeloma
             (MM): Preliminary results. (Abstract #8541)

 

About Carfilzomib

 

Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors. Carfilzomib produces specific and sustained inhibition of the proteasome, leading to apoptosis in cancer cells with minimal off-target effects. In Phase 1 and Phase 2 clinical trials, carfilzomib has demonstrated single-agent activity in hematologic malignancies and solid tumors, including multiple myeloma, Waldenstrom's macroglobulinemia, mantle cell lymphoma, and renal cell carcinoma.

 

Proteolix is conducting a comprehensive clinical development program evaluating carfilzomib for the treatment of multiple myeloma, including an ongoing accelerated approval study in heavily pre-treated relapsed/refractory patients and a Phase 2 trial in relapsed patients. A Phase Ib clinical trial of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma is also ongoing. In addition, Proteolix is conducting a single-agent Phase 2 clinical trial of carfilzomib in patients with recurrent or advanced solid tumors. For the latest information regarding ongoing carfilzomib clinical trials, please visit www.clinicaltrials.gov.

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Xencor to Present Phase 1 Data on XmAb®2513 Antibody for Lymphomas at the American Society of Clinical Oncology Annual Meeting

First Clinical Data from a Candidate Developed Using Xencor's Antibody Engineering Platform

Xencor, Inc., an antibody discovery and development company, will present data from its Phase 1 study of XmAb^®2513, an anti-CD30 Fc engineered humanized monoclonal antibody for the treatment of patients with relapsed Hodgkin lymphoma and anaplastic large cell lymphoma, on June 1 in a poster session at the American Society of Clinical Oncology Annual Meeting being held at the Orange County Convention Center in Orlando, Florida.

Poster Information

Date:						Monday, June 1, 2009
Poster Session:						2:00 – 6:00 PM (Level 2, W240A)
Poster Discussion:						5:00 – 6:00 PM (Level 2, West Hall F1)
Abstract:						#8531
Title:						"Phase 1 study of an anti-CD30 Fc engineered humanized monoclonal antibody in Hodgkin lymphoma (HL) or anaplastic large cell lymphoma (ALCL) patients: safety, pharmacokinetics (PK), immunogenicity and efficacy"

About XmAb2513

Xencor's lead candidate, XmAb^®2513, entered clinical development in 2008 for the treatment of relapsed Hodgkin lymphoma and T cell lymphomas. XmAb^®2513 is a humanized monoclonal antibody that targets the antigen CD30, a molecule expressed on the surface of a number of tumor cell types. XmAb^®2513 has been engineered to contain an XmAb^® Fc domain to greatly increase its cytotoxic potency. XmAb^®2513 shows superior activity in recruiting primary human immune cells to kill tumor cells in in vitro models and is active in blocking tumor growth in rodent models. XmAb^®2513 was humanized with Xencor's XmAb^® Fv technology and was well-tolerated in primate models. XmAb^®2513 is readily manufactured using standard monoclonal antibody production methods.

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EntreMed ENMD-2076 Phase 1 Data to Be Presented at ASCO Annual Meeting

ENMD-2076 Clinical Program Adds Leukemia Clinical Study and Orphan Drug Designation

 

ROCKVILLE, Md., May 15 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer today announced presentations for three of its clinical-stage drug candidates at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 29 - June 2, 2009 in Orlando, Florida. Presentations include both poster and discussion sessions and are listed below.

 

    * Poster Session: Friday, May 29, 2009 - 2:00 p.m. - 6:00 p.m. Abstract No.: 3520, "An open-label, dose escalation, safety, and pharmacokinetic study of ENMD-2076 administered orally to patients with advanced cancer."
          o Discussion Session: Friday, May 29, 2009 - 5:00 p.m. - 5:15 p.m. "Angiogenesis Inhibitors: New Agents and New Combinations," Level 4, Valencia Room, W415D.
    * Poster Session: Saturday, May 30, 2009 - 8:00 a.m. - 12:00 p.m. Abstract No.: 3562, "A single center, open-label, dose escalation, safety, and pharmacokinetic study of ENMD-1198 administered orally to patients with advanced cancer."
    * Poster Session: Sunday, May 31, 2009 - 2:00 p.m. - 6:00 p.m. Abstract No: 5577, "Phase 2 study of MKC-1 in patients with metastatic or resistant epithelial ovarian cancer or advanced endometrial cancer."

 

 

The Company has further expanded its clinical development efforts for ENMD-2076 and has commenced a Phase 1 study in patients with relapsed or refractory leukemia. The study will be conducted at the Princess Margaret Hospital in Toronto, Ontario and Karen Yee, M.D., will serve as Principal Investigator. Although the primary endpoints of the study include defining the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ENMD-2076 administered orally in patients with relapsed or refractory leukemia, the study will also evaluate pharmacodynamic effects of ENMD-2076 by collaborating with Dr. David Hedley, Department of Molecular Oncology, Ontario Cancer Institute (OCI).

 

Dr. Mark R. Bray, EntreMed Vice President, Research commented, "We are very excited to be working with Dr. Hedley and his staff, who have considerable experience in evaluating the mechanistic effects of kinase inhibitors like ENMD-2076 in cancer patients. The close proximity of EntreMed scientific personnel based in Toronto to our clinical collaborators at the OCI will facilitate our ability to obtain the maximum value from this study and its correlative components."

 

In addition, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for ENMD-2076 for the treatment of ovarian cancer. Several ovarian cancer patients participated in the ENMD-2076 Phase 1 study in solid tumors and will be included in the data presentations at ASCO. Orphan drug is a designation by the Food and Drug Administration indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Sponsors of drugs granted orphan designation qualify for tax credit and marketing exclusivity incentives of the Orphan Drug Act. Previously EntreMed had received orphan drug designation for ENMD-2076 for multiple myeloma.

 

EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented, "The clinical development program for ENMD-2076 is expanding with the addition of the myeloma clinical study announced earlier and with this new study in patients with leukemia. Also, plans are underway to expand the solid tumor study at the maximum tolerated dose of ENMD-2076 to further define the objectives of safety, pharmacokinetics and antitumor activity. We believe the current clinical program allows us to quickly add new patients to establish the potential of ENMD-2076 and provide a focus for Phase 2 development. These data serve as a foundation to continue discussions with potential development partners for ENMD-2076."

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ZymoGenetics says phase 2 results for IL-21 in Renal Cell Cancer show tolerability, enhanced efficacy of Nexavar combination - Quick Facts

ZymoGenetics, Inc. said it would present final results from a Phase 2 clinical trial in patients with renal cell cancer at the American Society of Clinical Oncology annual meeting on May 31, 2009. The clinical trial evaluated Interleukin 21 in combination with Nexavar or sorafenib tablets. The multi-center Phase 2 clinical trial was conducted at 14 sites in the U.S. and Canada and enrolled 33 patients. Efficacy endpoints included overall response rate and progression-free survival per RECIST or Response Evaluation Criteria In Solid Tumors.

 

The company said the ASCO abstract reports a 26% response rate in 2nd- or 3rd-line renal cell carcinoma patients. The final poster presentation would also include progression-free survival results.

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MedSource Awarded Services Contract for a Phase III Epilepsy Clinical Trial

MedSource, a Contract Research Organization (CRO) providing Phase I-IV clinical trials support, announced it has been awarded a service contract to manage a 50-center, multi-national, late phase epilepsy trial. The Houston-based CRO with regional offices in Raleigh, NC, will provide Project Management, Clinical and Regulatory services for the Phase III randomized, double-blind, placebo-controlled, cross-over trial.

 

"This award represents our client's satisfaction with our previous work and is seen as a vote of confidence in our continued abilities and expertise. It further solidifies our commitment to expand and deepen our Central Nervous System and epilepsy trial experience as well as our relationship with the Epilepsy Consortium," stated Eric Lund, President of MedSource.

 

"It is our intent to work toward establishing MedSource as a leader in this space," added Lund.

 

MedSource specializes in complex diseases and study designs and has experience in more than 400 trials in Phases I-IV. For more information, visit http://www.medsource.com.

 

About MedSource

MedSource is a premier Contract Research Organization (CRO) dedicated to delivering on-time, reliable clinical trial management services. MedSource has been providing quality results in Phase I-IV studies since 2001 and has extensive experience in complex clinical trials, with a particular expertise on oncology related programs. They have quickly grown into one of the premier CROs in North America and have been recognized as an Inc. 500 company. With clinical trial monitors located throughout North America and active vendor relationships globally, MedSource is able to quickly and effectively meet the clinical trial needs of their clients. More information about MedSource can be found at www.medsource.com or by calling (281) 286-2003.

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Pixantrone Phase 3 Data to be Presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that data from CTI's pivotal phase III EXTEND (PIX301) trial of pixantrone in patients with advanced, relapsed aggressive non-Hodgkin's lymphoma (NHL) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 29 to June 2, 2009 in Orlando, Florida.

 

Ruth Pettengell, M.D. of St. George's Hospital, University of London, an investigator on the study, is scheduled to present the data on Monday, June 1, 2009 during the Lymphoma and Plasma Cell Disorders session that will be held from 2:00 PM-6:00 PM Eastern Time. The presentation, abstract #8523, is titled, "Randomized Phase III trial of pixantrone compared with other chemotherapeutic agents for third-line single-agent treatment of relapsed aggressive non-Hodgkin's lymphoma." The abstract is available at www.asco.org.

 

CTI expects to complete the submission of a New Drug Application ("NDA") for pixantrone this quarter and will request priority review which if granted could lead to an approval decision from the U.S. Food and Drug Administration ("FDA") during the fourth quarter of 2009.

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Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009

- Data on BIBW 2992, an Irreversible, Dual EGFR / HER2 Tyrosine Kinase Inhibitor, Suggests Activity in Second-line Treatment of NSCLC Patients with EGFR Activating Mutations - (1,2)

 

-The First Presentation of Data on BIBF 1120 in Ovarian Cancer-

 

RIDGEFIELD, Conn., May 14 /PRNewswire/ -- Boehringer Ingelheim will present new data on the company's two lead oncology compounds, BIBW 2992 and BIBF 1120 at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO), the company announced today. Two studies in the LUX-Lung clinical development program for BIBW 2992 and a Phase II study of BIBF 1120 in ovarian cancer patients will be presented.

 

LUX-Lung 2 Interim Results

 

Interim Phase II data from the LUX-Lung 2 study suggest BIBW 2992 has anti-tumor activity in advanced, second-line, non-small cell lung cancer (NSCLC) patients who have epidermal growth factor receptor (EGFR) mutations.(2)

 

"Lung cancer kills more people than any other cancer.(3) The LUX-Lung 1 and 2 studies represent an opportunity to investigate BIBW 2992 across a range of different patient populations," said Dr. Manfred Haehl, corporate senior vice president, Medicine, Boehringer Ingelheim. "The preliminary data from the LUX-Lung 2 study suggests that BIBW 2992 may have activity in the second-line setting among NSCLC patients with EGFR mutations, which is encouraging news."(2)

 

BIBW 2992 is an orally-administered, irreversible dual inhibitor of the epidermal growth factor receptor (EGFR) and human epithelial receptor 2 (HER2) tyrosine kinases.(1) It is the first irreversible EGFR-TKI (tyrosine kinase inhibitor) to reach Phase III for third/fourth-line NSCLC.(4)

 

In the emerging era of personalized cancer medicine, Boehringer Ingelheim is one of the first companies to prospectively identify appropriate patients for clinical trials based on biomarkers. As part of the LUX-Lung clinical development program, Boehringer Ingelheim is evaluating BIBW 2992 in NSCLC patients who test positive for EGFR activating mutations.(5)

 

"It is well documented that 'activating' mutations that arise in the tyrosine kinase (TK) domain of the EGFR gene are associated with an increased sensitivity to first generation EGFR TKIs.(6,7,8) The majority of patients who initially respond to EGFR TKIs such as gefitinib or erlotinib will eventually develop resistance, often through gaining another mutation, such as the so-called T790M resistance mutation,"(9,10) said Dr. Haehl.

 

Detailed Findings from LUX-Lung 2:(2)

 

To date, 409 NSCLC patients have been screened in the LUX-Lung 2 study and 104 patients with EGFR mutations have started treatment with BIBW 2992 once daily. Preliminary data will be presented at ASCO for the first 73 second-line patients, all of whom had previously received one regimen of chemotherapy. Sixty-seven patients are evaluable for response.

 

Interim data show:(1)

 

    * 64% of patients (43/67) taking BIBW 2992 in the second-line setting experienced a partial response (75% among patients with deletion 19 and 66% in patients with L858R mutations)
    * 31% (21/67) of patients taking BIBW 2992 in the second-line setting experienced stable disease
    * Median progression-free survival (PFS) in second-line setting is 10.2 months
    * The most common related adverse events were diarrhea and skin-related disorders in 86% and 89% of patients respectively [16% and 18% being grade 3 respectively]
    * 37 patients had dose reduction and 4 patients discontinued treatment due to adverse events

 

Findings from LUX-Lung 1

 

In addition, preliminary data on the demographic and blinded safety data from the ongoing Phase III study, the LUX-Lung 1 trial, will be presented at ASCO for the first time.(5)

 

The LUX-Lung 1 study addresses a critical need for treatment options for NSCLC patients after failure with a second-line or third-line reversible EGFR inhibitor (i.e., erlotinib or gefitinib). This study recently moved from Phase IIb into Phase III.(5)

 

"The LUX-Lung 1 study is important as it investigates BIBW 2992 in a group of patients for whom there are no other approved treatment options. These are patients who have already been through standard first-line or second-line chemotherapy and then received treatment with an EGFR TKI. The LUX-Lung 1 study will evaluate whether BIBW 2992 will extend the lives of these cancer patients,"(5) said Dr. Haehl.

 

First Presentation of Phase II Data on BIBF 1120 in Ovarian Cancer

 

Data from a Phase II study of BIBF 1120 in patients with ovarian cancer who responded to at least second-line chemotherapy will be presented at ASCO in Orlando. The study showed a potential delay in disease progression: With BIBF 1120 the median time to RECIST progression was 4.8, versus 2.8 for placebo.(11) BIBF 1120 is an oral compound that works by simultaneously inhibiting vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs) -- all factors which are involved in the formation of blood vessels, a process known as angiogenesis.(12,13).

 

"There is a great need for more effective and well tolerated treatment options for women with ovarian cancer.(14) We have a growing body of evidence that anti-angiogenic agents may represent an important treatment approach for this disease,"(15,16,17) commented Prof. Jonathan A. Ledermann, MD, Professor of Medical Oncology & Director at the Cancer Research UK & UCL Cancer Trials Centre, University College London. "These data indicate BIBF 1120 may have a potential role in delaying disease progression in patients with ovarian cancer who had previously responded to chemotherapy."(11)

 

Because angiogenesis plays a pivotal role in the growth of solid tumors,(13) BIBF 1120 is currently being investigated in a number of cancer types including advanced NSCLC. The LUME-Lung Phase III clinical trial program is investigating BIBF 1120 in combination with standard second-line chemotherapy treatments for patients with advanced NSCLC. Approximately 2,600 patients will be enrolled, making this one of the largest Phase III study programs in this NSCLC patient population to date.

 

About Lung Cancer

 

Lung cancer is the world's most common cancer and kills more people than any other cancer.(3,14) In 2008, approximately 1.52 million new cases of lung cancer were diagnosed worldwide, with 1.31 million people dying from the disease.(14) In the United States, an estimated 161,840 deaths, accounting for 29 percent of all cancer deaths, occurred in 2008, according to the American Cancer Society (ACS).(18)

 

About Ovarian Cancer

 

According to the 2008 World Health Organization World Cancer Report, as of 2002, ovarian cancer was ranked as the 6th most common cancer in women. Additionally, approximately 204,000 new cases were diagnosed worldwide and 125,000 women died from the disease in 2002.(14) The ACS estimates that about 21,650 new cases of ovarian cancer were diagnosed in the United States (U.S.) during 2008. Only forty-five percent of women with ovarian cancer are still alive at least five years after diagnosis in the U.S.(19)

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Novavax Completes Enrollment of Its Second Phase II Seasonal Influenza VLP Vaccine Clinical Trial

Completion of enrollment keeps Company on track to report primary study results in third quarter of this year

 

Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the second Phase II clinical trial of its trivalent virus-like particle (VLP) seasonal influenza vaccine. This Phase IIa randomized, placebo-controlled study is evaluating a VLP vaccine against the H3N2, H1N1, and B influenza strains that circulated in the 2008-2009 influenza season. This clinical trial represents another step in the development of Novavax's VLP seasonal influenza vaccine, allowing further evaluation of safety and immunogenicity of a broad range of vaccine doses against a new set of influenza strains. As announced in December of 2008, the first Phase II study evaluated a trivalent VLP vaccine against the seasonal influenza strains that circulated in the 2005-2006 influenza season.

 

Specifically, this new study is evaluating the safety and immunogenicity of the 2008-2009 influenza vaccine in approximately 220 healthy adults between the ages of 18 and 49 years. Subjects have received a single injection of either a placebo or the VLP vaccine at doses of 15 mcg or 60 mcg per strain. The results of this study will be used to help select a dose for further evaluation in a clinical trial involving adults 65 years of age and older later this year and in a subsequent Phase III efficacy study.

 

"Enrollment of this second Phase II clinical trial represents another important developmental milestone for our VLP seasonal influenza vaccine program," said Dr. Rahul Singhvi, President and CEO of Novavax. "This study provides the opportunity to evaluate the safety and immunogenicity of our VLP vaccine against a new set of influenza strains, further strengthening our growing clinical database for VLP-based influenza vaccines. The completion of enrollment keeps us on track for having top line data for the 2008-2009 vaccine in the third quarter of this year and for selecting a dose for a Phase II trial in older adults later this year."

 

 

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AGI Therapeutics: Top-line results of Phase III study of Rezular

Announces top-line results of Phase III study of RezularTM in IBS-D

 

Dublin, Ireland, 15 May 2009 - AGI Therapeutics plc ("AGI" or the"Company") (AIM, IEX: AGI), a speciality pharmaceutical development company focused on gastrointestinal drug products, today announces top-line results from it's Phase III clinical study, ARDIS 1, of RezularTM, in diarrhoea-predominant Irritable Bowel Syndrome (IBS-D).

 

  - The study did not show statistically significant differences
    between treatments in the primary endpoint of patient reported
    adequate relief of IBS symptoms
  - Statistically significant evidence favouring Rezular treatment was
    achieved in a number of secondary endpoints, particularly those
    relating to aspects of diarrhoea (e.g. stool form as assessed by
    the Bristol Stool Scale), stool frequency and in the majority of
    sub-categories of quality-of-life (IBS-QOL) scores and in the
    overall IBS-QOL score
  - There were no statistically significant differences between
    treatments in adequate relief of pain/discomfort or change in
    severity of pain
  - Based on this preliminary data analysis, AGI does not believe that
    Rezular will meet the regulatory requirements for an effective
    therapy for the broad IBS-D population and plans to cease its
    development in this indication.

 

ARDIS 1 was a randomised, double-blind, placebo-controlled, parallel group, Phase III study in IBS-D patients (both men and women). There were four treatment arms (placebo and three dose levels of RezularTM) and patients were treated for 12 weeks of double-blind therapy. A total of 711 patients were randomised in 123 clinical centres in the United States, Europe and South America. Of the total patients randomised, 63% were in the United States.

 

Dr John Devane, CEO of AGI, commented:"A safe and effective therapy for patients with IBS-D remains elusive.

We are very disappointed that this study did not achieve its primary clinical endpoint. While we saw evidence that RezularTM has activity in many aspects of this multi-symptom disease, as in our earlier study, our experience in bringing products to market suggests to us that the pursuit of this product as a therapy for IBS-D would not be a prudent use of our resources. AGI has a promising portfolio of other products. Recently we announced positive proof-of-concept Phase II results for AGI004 in the treatment of chemotherapy-induced diarrhoea (CID) in cancer patients. We will now focus our efforts on prioritising our pipeline and plan how best to move these forward. We will keep our shareholders apprised of these plans."

 

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Bayer's Nexavar shows promise in lung cancer study

Bayer's (BAYG.DE) cancer drug hopeful Nexavar showed promise as a lung-cancer treatment in a Phase II study, the ASCO association of U.S. oncologists said on its Website on Friday. The authors of the Phase II study, which will be presented in detail at ASCO's annual meeting at the end of this month, concluded that the combination of Nexavar and Roche's (ROG.VX) approved lung cancer drug Tarceva "is safe and has clinically significant anti-tumour activity."

 

The trial involved 50 lung-cancer patients whose tumours had started spreading and which had not previously received chemotherapy.

 

Nexavar's potential use against lung tumours, the most common form of cancer, was thrown into doubt in February last year when a Phase III study was halted because the pill failed to show the desired effects.

 

Bayer and development partner Onyx Pharmaceuticals (ONXX.O) said at the time they would have to analyse the study data to determine what impact it would have on other ongoing Nexavar lung cancer trials.

 

Every year, more than 1.3 million people are diagnosed with lung cancer globally.

 

A Bayer spokeswoman declined to comment on the ASCO data on Friday but said the company was looking forward to results to be presented at the upcoming meeting that help it understand the potential of Nexavar in combating difficult-to-treat tumour types.

 

Further Nexavar data on liver, kidney, thyroid and gastric cancers as well as leukaemia will be presented at the ASCO meeting.

 

Nexavar, which is approved for liver and kidney cancer in more than 70 countries, is Bayer's most promising pharmaceutical -- alongside anti-blood-clotting pill Xarelto -- with an annual sales potential of more than 2 billion euros ($2.71 billion).

 

Bayer is currently testing the Nexavar pill against lung cancer in a further two studies in Phase II and III, respectively. Three phases are usually required before a drug can be filed for regulatory approval.

 

The study data released on Friday showed that 76 percent of the patients treated with the drug combination did not see their cancer worsen within six weeks. The study did not include a control group. (Reporting by Ludwig Burger; Editing by Rupert Winchester)

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Apogenix Reports Positive Phase I Results on its Lead Compound APG101

Apogenix GmbH, a biopharmaceutical company developing novel drugs forr malignant and inflammatory diseases, today reported clinical phase I results on its leas compound APG101. APG101 is a protein influencing an important signaling mechanism involved in the onset and maintenance of these diseases.

 

The randomized study, which was initiated in September 2008 to explore the safety and tolerability of APG101, included 34 healthy volunteers. All endpoints of the double-blind, placebo-controlled, mono-centric study were met. APG101 was well tolerated and no serious adverse side events were observed. The study was designed as a dose escalation trial with seven cohorts of patients who received increasing single doses of APG101.

 

"These results are an important step for the further clinical development of APG101 in various disease indications," sad Dr Harald Fricke, Chief Medical Officer of Apogenix. "We have already demonstrated the mode of action of APG101 as an inhibitor of cell migration, invasive growth, and apoptosis in preclinical studies, and we are now very much looking forward to demonstrate the compound's therapeutic potential in patients."

 

Apogenix is currently preparing a phase II study with patients suffering from Glioblastoma, a brain tumor characterized by its highly aggressive invasive growth. The trial is expected to start in the first half of 2010 and will be designed as an open-label, controlled study to achieve clinical proof of concept. Results should be available in 2011. Furthermore, it is planned to initiate additional phase II trials with APG101 such as for the prevention of acute "Graft-versus-Host Disease", an indication for which the European Commission has granted orphan drug status.

 

About Apogenix

 

Apogenix is a biopharmaceutical company developing novel drugs based on the targeted modulation of CD95 and Interleukin-4 receptor mediated signaling pathways. These pathways play an important role in a variety of malignant and inflammatory diseases.

 

Apogenix is a spin-out from the German Cancer Research Center (DKFZ), and is based in Heidelberg, Germany. Since 2005, the company has raised EUR 43 million in two financing rounds, mainly from the family of the renowned biotech investor and SAP co-founder Dietmar Hopp.

 

About APG101

 

APG101 is a human, soluble fusion protein combining the extracellular domain of the CD95-receptor and the FC portion of IgG1. CD95 is a receptor with pleiotropic functions transmitting apoptotic and non-apoptotic signals such as migration and invasion of tumor cells, and is triggered by the CD95 ligand (CD95L). APG101 blocks CD95-mediated signaling pathways by binding to the ligand, thereby blocking activation of the CD95 system.

 

Available research data shows that the blockade of CD95L plays an importnat role in the pathophysiology of diseases characterized either by an invasion-prone phenotype such as, e.g. Glioblastoma or by an excess of apoptosis, such as acute "Graft-versus-Host Disease" (aGvHD) or myocardial infarction. APG101 has demonstrated a dose-dependent effect in a variety of animal models of the above mentioned diseases and is in clinical development for the treatment of Glioblastoma and the prevention of aGvHD.

 

Apogenix has been granted orphan drug status for APG101 for the prevention of aGvHD by the European Commission in 2006. The product candidate is covered by four different patent families claiming the composition of matter as well as its use for different indications.

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Medicines Slips on Cangrelor Setback; Stops Phase III Trials

Shares of the Medicines Co. got knocked around after the Parsippany, N.J.-based firm halted two massive Phase III trials of antiplatelet agent cangrelor, eliminating the chances of a 2010 product launch to stave off an expected revenue decline when its top-selling drug, Angiomax, goes off patent next year.

 

The company's stock (NASDAQ:MDCO) dropped $4.12, or 37 percent, to close Wednesday at $7.02.

 

The decision followed a futility analysis from the CHAMPION-PLATFORM study, which started enrollment in October 2006 and had recruited about 83 percent of its planned 6,400 patients to date.

 

An interim analysis review committee reported that the trial would not meet the goal of demonstrating "persuasive evidence" of efficacy when given in combination with usual care vs. usual care plus placebo, in patients undergoing percutaneous coronary intervention (PCI), CEO Clive Meanwell told investors during a conference call.

 

Results "do not provide sufficient evidence of clinical effectiveness to warrant regulatory submissions," he added.

 

That same committee also reported that a second trial - having enrolled 98 percent of its planned 9,000-patient target - had fallen short of expectations.

 

That study, designated CHAMPION-PCI, was designed to test cangrelor treatment compared to Plavix (clopidogrel, Sanofi-Aventis and Bristol-Myers Squibb Co.) in patients who require PCI, and data showed no significant differences in measures of clinical efficacy.

 

The Medicines Co. said safety findings for cangrelor were similar to clopidogrel and were consistent with side effects seen from short-term P2Y12 platelet inhibition, including an increase in minor bleeding.

 

"We had high hopes for the future revenue-generating potential of cangrelor," Meanwell said. "But it's in the nature of our business that some things don't work out as we'd hoped, and we have to move on to new ideas."

 

For the Medicines Co., that means shifting focus of cangrelor for the short-term use in settings where oral drugs cannot be used or when a short half-life is needed. The firm recently started the BRIDGE study, expected to enroll about 200 patients who discontinue clopidogrel in preparation for cardiac surgery.

 

The idea is to provide the "safe bridging of patients during the perisurgical period of risk when thrombosis is likely in the absence of oral platelet inhibition," Meanwell said.

 

But he added that he anticipates the BRIDGE study being about "a year project," which marks what might be a critical delay for the Medicines Co., starting in 2011.

 

Angiomax (bivalirudin), an anticoagulant that's expected to pull in between $425 million and $445 million in revenue this year, is set to lose patent protection in 2010, due to an attorney missing a patent filing deadline. The company has lobbied Congress to reinstate patent protection to 2014, but barring legislation passed by Congress, the Medicines Co. anticipates being hit with at least a 20 percent top-line decline in 2011.

 

Analyst Joseph Schwartz, of Leerink Swann & Co., however, wrote in a research note that the market is "not accurately valuing the Angiomax opportunity."

 

He said, due to a difficult manufacturing process, the drug is expected to have only a "limited number of generic threats," and has modeled a 50 percent reduction in sales in 2011, followed by a modest 2.5 percent growth in Angiomax sales thereafter.

 

Leerink also believes that the firm has a strong case against the law firm that missed the filing under the Hatch-Waxman patent extension and "thus could at least get a lump sum for foregone revenues that could be returned to shareholders."

 

The Medicines Co., which reported a cash position of $164.3 million as of March 31, also expects to save about $5 million over the remainder of 2009 due to two discontinued studies.

 

The firm also hopes to make up for declining Angiomax revenue with oritavancin, an antibiotic drug picked up through its acquisition of Cambridge, Mass.-based Targanta Therapeutics Corp. earlier this year. But that launch could be three years away.

 

Targanta had gotten oritavancin through a complete response letter late last year, in which the FDA requested an additional Phase III cSSSI trial that included a significant proportion of patients with methicillin-resistant Staphylococcus aureus. (See BioWorld Today, Dec. 10, 2008.)

 

During the investor call, Meanwell ballparked oritavancin's potential launch in 2012, stating that "until we know what the FDA needs from us," the firm would not be able to provide a more specific time frame.

 

He added that the Medicines Co. aimed to start recruiting patients in the confirmatory Phase III study by the end of this year.

 

If eventually approved, oritavancin also could face competition from South San Francisco-based Theravance Inc.'s telavancin and Basel, Switzerland-based Basilea Pharmaceutica AG's ceftobiprole, both of which also have received complete response letters in cSSSI.

 

In addition to Angiomax, the Medicines Co. also markets Cleviprex (clevidipine), which gained approval last year in acute hypertension.

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AlphaVax Announces Promising Results in Melanoma Studies

AlphaVax announced today the presentation of promising results from a collaboration with researchers at the Memorial Sloan-Kettering Cancer Center (MSKCC). Francesca Avogadri, Ph.D., a Research Fellow in the Department of Medicine at MSKCC presented data at the American Association of Immunologists Annual Meeting in Seattle, Washington.

 

Results from pre-clinical studies conducted at MSKCC demonstrate the ability of AlphaVax's virus-like replicon vector particles (VRP) encoding melanoma-specific tumor antigens to reduce melanoma tumor burden in a state-of-the-art murine melanoma model.

 

Jedd D. Wolchok, M.D., Ph.D., Lab Head and faculty member at MSKCC, is a medical oncologist who specializes in the treatment of melanoma and in whose laboratory the work was conducted. Dr. Wolchok's research is focused on harnessing the immune system to prevent melanoma from recurring after surgery, as well as more effective treatments for the disease when it does recur. In comparing these results to others that his lab has investigated, Dr. Wolchok commented that "this is the most potent single intervention we have seen in this model."

 

"We are excited by the results obtained in the studies conducted by Dr. Wolchok's group at MSKCC. Immunotherapeutic intervention with a novel vaccine vector such as ours may prove beneficial as a treatment strategy for patients with melanoma, and we hope to translate these findings into clinical testing in the near future," said Robert Olmsted, Ph.D., Vice President of Research at AlphaVax, Inc.

 

The American Cancer Society estimates that nearly 62,500 people were diagnosed with melanoma of the skin in 2008, and over 8,400 deaths were due to the disease. While melanoma accounts for a small percent of all skin cancers, it is far more serious than other skin cancers if not detected and treated early. Melanoma is a form of cancer that begins in melanocytes (cells that make the pigment melanin). Current treatment of later-staged melanoma includes surgical removal of the tumor tissue, followed by chemotherapy and/or radiation therapy.

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The Medicines Company Discontinues Phase 3 CHAMPION Clinical Trial Program of Cangrelor

The Medicines Company Discontinues Phase 3 CHAMPION Clinical Trial Program of Cangrelor

Interim Analyses Indicate CHAMPION Program Will Not Meet Efficacy Endpoints 

Company to Continue and Accelerate Phase 2/3 Studies of Cangrelor in Settings Where Oral Drugs Cannot Be Used or Short Half-Life Is Desirable

The Medicines Company (NASDAQ: MDCO) today announced that it is discontinuing its Phase 3 CHAMPION clinical trial program of cangrelor in patients undergoing percutaneous coronary intervention (PCI). 

The program's independent Interim Analysis Review Committee (IARC), after conferring with the Drug Safety Monitoring Board, reported to the Company that the CHAMPION-PLATFORM trial would not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval. This placebo-controlled trial compared treatment with cangrelor (in combination with usual care) to usual care in patients who require PCI. 

The IARC also reported to the Company that, based on updated information, the CHAMPION-PCI trial, a clinical trial comparing treatment with cangrelor to clopidogrel (600 mg loading dose) in patients who require PCI, showed no significant differences in measures of clinical effectiveness. 

Safety findings for the program were consistent with those expected from short-term P2Y12 platelet inhibition and included an increase in minor bleeding among patients given cangrelor in comparison to placebo, but not in comparison to clopidogrel. 

Based on the totality of these data, the IARC has recommended that enrollment in both trials be discontinued and that all remaining data should be collected and analyzed. The Company is in the process of notifying the investigators and regulatory agencies of the discontinuation of the CHAMPION program. 

The IARC also recommended that the Company should consider focusing on short-term use of cangrelor in settings where oral drugs cannot be used or when a short half-life is highly desirable. Consistent with guidance from the IARC, cangrelor is already being studied in such a setting. The BRIDGE study aims to establish the dosage of cangrelor that achieves greater than or equal to 60% inhibition of platelet aggregation for five days. The Company plans to enroll approximately 200 patients who discontinue clopidogrel in preparation for cardiac surgery. The aim is to show safe "bridging" of patients during the pre- and post-surgical period of risk. If successful, this approach may form the basis for subsequent regulatory filings.

"We are disappointed that the CHAMPION program has not provided sufficient evidence of the clinical effectiveness of cangrelor to warrant completion of these Phase 3 trials. We thank the Investigators and oversight Committees for their work and we will follow their guidance. The trials are being discontinued; we plan to finalize data collection and analyses, and we expect that the data will be presented at a major cardiology meeting in due course. We will now move forward more quickly with our studies where cangrelor is tested to enable safe 'bridging' of patients undergoing surgery. In this setting of high unmet medical need, long-term clopidogrel is often discontinued at considerable risk to patients. The rapid onset, offset and titratable anti-platelet pharmacology of cangrelor seems ideally suited for this potential use. The development of cangrelor will therefore continue," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company.

"Looking longer term, it is important to note that The Medicines Company is not dependent on a single product. We have a diversified portfolio of current and pipeline products, industry-leading operational capabilities and we are cash flow positive. We believe the Company is well positioned to deliver future growth and long-term shareholder value. We remain committed to our strategy of building a leading global critical care hospital medicines business. We will continue to focus on our market-leading Angiomax product, the Angiox business, the ongoing Cleviprex launch in the United States and international Cleviprex regulatory filings now underway, advancing Phase 3 trials of oritavancin and on our early stage development program with CU2010," he continued.

The Company noted that the discontinuation of the CHAMPION program will result in cost savings of approximately $5 million in 2009. 

Cangrelor

Cangrelor is an investigational intravenous antiplatelet agent exclusively licensed in December 2003 from AstraZeneca. 

The Phase 3 program for cangrelor consisted of two large studies with a combined planned total enrollment of 15,400 patients. The CHAMPION-PCI study, which commenced enrollment in March 2006, enrolled 98% of the patients out of a planned target of 9,000 patients. The objective of this study was to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia driven revascularization (IDR) at 48 hours after PCI. The second trial in the Phase 3 program, referred to as CHAMPION-PLATFORM, commenced enrollment in October 2006 and enrolled 83% of the planned target of 6,400 patients. The objective of this study was to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring PCI, as measured by a composite of all-cause mortality, MI, and IDR. 

In both studies, the incidence of hemorrhage by clinically relevant criteria (ACUITY, GUSTO, TIMI) and the need for blood transfusions was also measured up to 48 hours. 

The Medicines Company will host a conference call today, Wednesday, May 13, 2009 at 8:30 a.m. Eastern Time. The conference call will be available via phone and webcast. The dial in information is listed below: 

Domestic Dial In: 866-383-8108
International Dial In: 617-597-5343
Passcode for both dial in numbers: 97511198

Replay is available from 11:30 a.m. Eastern Time following the conference call through May 27, 2009. To hear a replay of the call, dial 888-286-8010 (domestic) and 617-801-6888 (international). Passcode for both dial in numbers is 27752004. 

This call is being webcast and can be accessed at The Medicines Company website at www.themedicinescompany.com. 

 

About The Medicines Company

The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage development and a serine protease inhibitor, CU-2010, in early-stage development. Through the acquisition of Targanta Therapeutics, The Medicines Company's pipeline includes oritavancin, a semi-synthetic lipoglycopeptide antibiotic currently awaiting EU regulatory approval. The Medicines Company's website is www.themedicinescompany.com. 

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects" and "estimates" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include: whether the Company will be able to obtain regulatory approvals; whether the Company's products and product candidates will advance in the clinical trial process on a timely basis or at all; whether clinical trial results will warrant submission of applications for regulatory approval; whether physicians, patients and other key decision-makers will accept clinical trial results; whether the Company will be able to successfully distribute and market its approved products; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on May 11, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements. 
         
Contact:
Katherine Stueland
WeissComm Partners
Phone: (312) 646-6299
kstueland@wcpglobal.com
Robyn Brown
The Medicines Company
Phone: (973) 290-6000
investor.relations@themedco.com

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Stem Cell Therapeutics Corp. Announces the FDA Has Lifted Its Clinical Hold on the Phase IIb Stroke Trial

Stem Cell Therapeutics Corp. ("SCT" or "the Company") (TSX VENTURE:SSS) is pleased to announce the U.S. Food and Drug Administration ("FDA") has provided a verbal confirmation to remove its clinical hold placed on NTx®-265 on September 18, 2008. This will allow SCT to commence the recruitment of patients under an amended protocol using NTx®-265 for the Company's Phase IIb clinical trial treating acute ischemic stroke.

 

Dr. Alan Moore, President and CEO, commented as follows:

 

"We are very pleased that our series of collaborative meetings with the FDA has resulted in this positive development. We are expecting to receive written notification from the FDA in the near future following which we will finalize the plans for our stroke trial. We will issue another press release once this has been determined."

 

About REGENESIS: NTx®-265 is SCT's lead therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin ("hCG") and Erythropoietin ("EPO"), targeting the treatment of stroke. The twin objectives of the treatment are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual, and cognitive recovery after the acute ischemic stroke. Encouraging clinical results from SCT's BETAS Phase IIa stroke trial were presented at the International Stroke Conference in February 2009, showing clinically relevant recovery in 12 of 12 patients who received the complete treatment.

 

About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The Company's programs aim to repair brain and nerve function lost due to disease or injury. The Company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington's disease, Alzheimer's disease, and ALS.

 

For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.

 

These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.

 

Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

 

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

 

For more information, please contact
Stem Cell Therapeutics Corp.
Alan Moore, PhD
President and CEO
403-245-5495 ext. 224
amoore@stemcellthera.com

 

or

 

Stem Cell Therapeutics Corp.
Chloe Douglas-Crampton
Investor Relations
403-245-5495 ext. 221
crampton@stemcellthera.com
www.stemcellthera.com

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Swedish Medical Products Agency approves start of Phase I clinical trial with APR-246, the anticancer candidate of Aprea

Aprea announced today that the Swedish Medical Products Agency has approved the start of a Phase I clinical trial with Aprea's candidate drug, APR-246. Scheduled to begin during May 2009, the Phase I-study includes patients with refractory hematologic malignancies or prostate carcinoma.

 

The study is expected to be finalized in the end of 2010. APR-246 is a unique new substance developed by the research company Aprea, located in the Karolinska Institute Science Park. Several of the most serious forms of cancer that are difficult to treat contain a mutated tumor suppressor protein called p53. In preclinical studies, APR-246 has been shown to reactivate p53, and in animal studies it has shown good anticancer efficacy and limited side effects.

 

"There is a high unmet medical need for new effective anticancer drugs, so we are very pleased that APR-246 will now enter into clinical phase," says Thomas Uhlin, President of Aprea. "APR-246 offers a new concept to treat cancer that differs from conventional treatment with chemotherapy."

 

We are looking forward to study the effects of APR-246 in a clinical trial for the first time. The substance has shown to be effective in preclinical models in several hematologic malignancies," says Sören Lehmann, PhD., M.D., hematologist at Karolinska University Hospital in Huddinge and Coordinating Investigator for this FIM-study.

 

For more information, please contact: Thomas Uhlin, President of Aprea, phone +46 705 335 137 e-mail: thomas.uhlin@aprea.com, www.aprea.com

 

About Aprea Aprea was founded in March 2003 by Prof. Klas Wiman, Assoc. Prof. Galina Selivanova, Assoc. Prof. Vladimir Bykov, Assoc. Prof. Staffan Strömblad, Wenjie Bao, PhD., Natalia Issaeva , PhD., and Karolinska Innovations AB, Aprea AB develops specific drugs to treat cancer with non-functional p53. The company specializes in developing substances from preclinical research to proven efficacy in Phase II-studies in cancer patients. Aprea's principal investors are Karolinska Development AB, Industrifonden, Östersjöstiftelsen and Praktikerinvest.

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Results From Phase 3 CAPACITY Program of Pirfenidone in IPF and Study of Predictors of Mortality in IPF to be Presented at ATS

InterMune, Inc. (Nasdaq:  ITMN) today announced that an oral late-breaker presentation and two poster discussion presentations related to the company's pulmonology programs will be presented at the 2009 International Conference of the American Thoracic Society (ATS) in San Diego. In addition, the company will conduct a conference call and webcast to discuss the results of its Phase 3 CAPACITY program on Tuesday, May 19 at 6:00 p.m. PDT (9:00 p.m. EDT).

 

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased that our Phase 3 CAPACITY program will be the subject of two significant sessions at this year's ATS meeting. Details of the CAPACITY results will be presented in a poster discussion session on the morning of Sunday, May 17. A more in-depth presentation of the efficacy and safety data from the two CAPACITY studies will be the subject of an oral late-breaker presentation on Tuesday, May 19. In addition, the results of a large study examining the predictors of mortality in patients with idiopathic pulmonary fibrosis (IPF) will be presented in a poster discussion session on Sunday, May 17. Among the independent predictors of mortality identified in the study was change in percent predicted forced vital capacity (FVC), the primary endpoint and a component of important secondary endpoints in our CAPACITY program."

 

The schedule of presentations at ATS related to InterMune's efforts in the research and development of new medicines for IPF are as follows:

 

    SUNDAY, MAY 17
    POSTERS: (A23) INTERSTITIAL LUNG DISEASE: OUTCOMES AND SELECTED CLINICAL
    ISSUES

 

         Room: 6 F (Upper Level)

 

         Session time: 8:15 a.m. - 10:45 a.m.  (Poster Viewing: 8:15 a.m. -
         9:15 a.m.  Discussion 9:15 a.m. - 10:45 a.m.)

 

         POSTER 201: R. du Bois:  PREDICTORS OF MORTALITY IN PATIENTS WITH
         IDIOPATHIC PULMONARY FIBROSIS (IPF)

 

         POSTER 216: P.W. Noble:  THE CAPACITY (CAP) TRIALS:
         RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III TRIALS OF
         PIRFENIDONE (PFD) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
         (IPF)

 

    TUESDAY, MAY 19
    LATE BREAKING CLINICAL TRIALS (C98)

 

         Room 7 A-B (Upper Level)

 

         3:35 p.m. - P.W. Noble:  PIRFENIDONE IN THE TREATMENT OF
         IDIOPATHIC PULMONARY FIBROSIS: RESULTS OF TWO RANDOMIZED, DOUBLE-
         BLIND, PLACEBO-CONTROLLED, PHASE III TRIALS (THE CAPACITY TRIALS)

 

Webcast Details

 

InterMune will host a teleconference and webcast on Tuesday, May 19 at 6:00 p.m. PDT (9:00 p.m. EDT), in which Dr. Paul Noble, co-chair of the CAPACITY program and Professor of Medicine and Chief of Pulmonary, Allergy and Critical Care Medicine at Duke University Medical Center, will present his oral presentation of the CAPACITY results and accompanying slides. Dr. Roland du Bois, Professor of Medicine at National Jewish Health, Denver, Colo., and CAPACITY co-chair, will also participate in the webcast.

 

To access the live teleconference, dial 888-799-0528 (U.S.) or 973-200-3372 (international), conference ID# 97738057. To access the live audio webcast of the conference call, please log on to the investor relations page of the company's website at www.intermune.com. The company recommends logging on to the site 15 minutes prior to the start of the presentation in order to register or download any necessary software.

 

A replay of the webcast and teleconference will be available approximately three hours after the call. The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 97738057.

 

About InterMune

 

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF, RECAP, an open-label extension study from CAPACITY and a research program focused on small molecules for the treatment of pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche, its development partner) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating new targets in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.

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VIA Pharmaceuticals Announces Complete Enrollment in FDG-PET Phase 2 Study of VIA-2291 in Cardiovascular Patients

Comprehensive Phase 2 Program Combines Histology, Biomarkers and Non-Invasive Imaging to Demonstrate Mechanism of Action and Positive Impact on Vascular Inflammation

 

SAN FRANCISCO, May 14 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, today announced that it has completed enrollment in a Phase 2 clinical trial of its lead drug, VIA-2291 in patients who have experienced an acute coronary syndrome event such as a heart attack or unstable angina. The randomized, double blind, placebo-controlled study examines the impact of VIA-2291 on plaque inflammation as measured by Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET), as well as other standard biomarkers of inflammation, over 24 weeks following such an acute event. A total of 52 patients have been enrolled in the study, which is expected to report data in the second half of 2009.

 

VIA-2291 is designed to be a selective and reversible inhibitor of 5 Lipoxygenase, a key enzyme in the biosynthesis of leukotrienes, which are important mediators of inflammation believed to be involved in the development and progression of atherosclerosis. The FDG-PET study is the third Phase 2 clinical trial of VIA-2291 conducted by the Company in cardiovascular disease. In addition to being generally well-tolerated, earlier studies reported at the American Heart Association 2008 Scientific Sessions in November 2008, and the American Heart Association Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2009 in May 2009, suggest multiple effects of the drug on inflammation, as measured through histology, biomarkers and advanced imaging. These include:

 

    * Significant, dose dependent, inhibition of Leukotriene B4 (LTB4) production,
    * A significant reduction from baseline as compared with placebo of high sensitivity C-reactive protein (hs-CRP),
    * A reduction in necrotic core thickness relative to plaque thickness as measured with histology, and
    * A significant reduction in plaque volume and a reduced number of new plaque lesions as measured by serial multidetector computed tomography (MDCT) scans.

 

"There is growing weight to the evidence supporting VIA-2291's effect on inflammation in atherosclerotic plaques," said Rebecca A. Taub, M.D., Sr. Vice President - Research & Development of VIA Pharmaceuticals. "No therapy currently exists to directly target inflammation, an underlying cause of atherosclerosis and major adverse cardiac events, such as heart attack and stroke. FDG-PET is a new and leading-edge imaging technology for cardiovascular patients, that we feel will provide yet another insight into VIA-2291's ability to target plaque inflammation in patients with serious cardiovascular disease. In addition, the FDG-PET study focuses on the target patient population that is relevant to our anticipated, larger outcome studies."

 

About VIA Pharmaceuticals, Inc.

 

VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease. VIA's lead candidate, VIA-2291, targets a significant unmet medical need: reducing inflammation in plaque, an underlying cause of atherosclerosis and its complications, including heart attack and stroke. In addition, VIA's pipeline of drug candidates includes other compounds to address other underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation. For more information, visit: http://www.viapharmaceuticals.com.

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New MADIT II Clinical Data Analysis Shows Long-Term Survival Benefit for Implantable Defibrillator Therapy

Analysis indicates that one life is now saved for every six patients who receive an ICD

 

NATICK, Mass., May 14 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that an analysis of long-term data from the MADIT II clinical study demonstrates that the life-saving benefits of implantable cardioverter defibrillator (ICD) therapy remain sustainable at eight years. This is the first time long-term data have been presented regarding the life-saving benefits of ICDs in a primary prevention population. The analysis was presented during a late-breaking session at the Heart Rhythm Society Scientific Sessions in Boston.

 

The analysis shows a sustainable mortality benefit over time, including:

 

    * At eight years, one life is saved for every six patients who receive an ICD. This represents a significant improvement over the two-year MADIT II data, which showed one life saved for every 17 patients.
    * A 41 percent relative reduction in the risk of death for ICD patients at four years
    * A 37 percent relative reduction in the risk of death for ICD patients at eight years

 

The MADIT II study, sponsored exclusively by Boston Scientific, was designed to determine whether ICDs improve survival when compared to drug therapy alone in heart attack survivors with moderate impairment of the left ventricle, the heart's main pumping chamber. Initial results published in the New England Journal of Medicine (March 21, 2002) demonstrated that ICD therapy reduced the relative risk of death by 31 percent at 20 months follow-up.

 

"ICD therapy has proved effective in patients at risk of sudden cardiac death, and now the long-term MADIT II data show the life-saving benefits of these devices continue over time," said Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical Center and Principal Investigator of the MADIT, MADIT II and MADIT-CRT trials.

 

"We are proud to have been the exclusive sponsor of landmark trials like MADIT II," said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. "More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this life-saving therapy through Boston Scientific clinical research."(1)

 

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: