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GlaxoSmithKline and Redwood City, California-based OncoMed Pharmaceuticals said they formed a worldwide strategic alliance to discover, develop, and market novel antibody therapeutics to target cancer stem cells, which are believed to play a key role in the establishment, metastasis, and recurrence of cancer. The alliance with GSK will be conducted through its Center of Excellence for External Drug Discovery. The alliance leverages OncoMed's expertise in the discovery and development of cancer stem cell antibody therapeutics and provides GSK with an option to license four product candidates directed at multiple cancer stem cell targets from OncoMed's broad library of monoclonal antibodies. OncoMed will receive an undisclosed initial payment comprised of cash as well as an equity investment. In addition, OncoMed is eligible to earn milestone payments up to $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory, and commercial milestones. OncoMed will also receive double-digit royalties on all collaboration product sales. GSK will have an option to invest in a future initial public offering by OncoMed.

 

Biologists have created baker’s yeast capable of living to ten times its normal life expectancy without apparent side effects. Researchers at the University of Southern California said the basic but important discovery, achieved through a combination of dietary and genetic changes, brings science closer to controlling the survival and health of the cells of all living systems. The study will be published in the journal PLOS Genetics; and a companion study, showing that the same genetic changes in yeast reverse the course of an accelerated aging syndrome, appears in the Journal of Cell Biology. The researchers put baker’s yeast on a calorie-restricted diet and knocked out two genes, RAS2 and SCH9, which promote aging in yeast and cancer in humans. The researchers plan next to investigate life span extension in mice and are studying a human population in Ecuador with mutations analogous to those described in yeast.

 

Sexually active gay men are many times more likely than others to acquire a new, highly antibiotic-resistant strain of the so-called MRSA bacteria widely know as the "superbug," a study lead by researchers at the University of California at San Francisco shows. The bacteria appear to be transmitted most easily through intimate sexual contact, but can also spread through casual skin-to-skin contact or contact with contaminated surfaces. The scientists are concerned that it could soon gain ground in the general population. The new strain of bacteria is closely related to the MRSA bacteria that have spread beyond hospital borders in recent years and caused outbreaks of severe skin and other infections. But the newly discovered microbe is resistant to many more front-line antibiotics. Both strains are technically known as MRSA USA300. Like its less antibiotic-resistant sibling, the new multi-drug resistant microbe spreads easily through skin-to-skin contact, invading skin, and tissue beneath the skin. Both strains cause abscesses and ulcerations that can progress rapidly to life-threatening infections. The researchers, who published their study in the Annals of Internal Medicine, said that research should be undertaken to explore the link between MRSA and unsafe sexual risk behaviors.

 

PROSTATE CANCER: COMMITTEE FINDS DATA SUPPORTS CONTINUATION OF GVAX TRIAL FOR CELL GENESYS VACCINE
South San Francisco, California-based Cell Genesys said that the Independent Data Monitoring Committee for the first of two ongoing late-stage clinical trials of its GVAX immunotherapy for prostate cancer has completed a planned interim analysis and has recommended that the study continue. The interim analysis was designed to determine whether the study should continue to completion and took place in the time frame originally estimated. As is customary to preserve study blinding, the IDMC provided no information to the company other than the recommendation to continue the trial. The committee said it expects the trial to continue in the second half of 2009. The trail is designed to compare the company’s GVAX cancer immunotherapy to Taxotere (docetaxel) chemotherapy plus prednisone in hormone refractory prostate cancer patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival.

 

Pleasanton, California-based Juvaris BioTherapeutics said that it entered into a Cooperative Research and Development Agreement with the Centers for Disease Control and Prevention for the evaluation of the company’s H5N1 pandemic influenza adjuvant vaccine. This collaborative study will determine if the use of the Juvaris JVRS-100 adjuvant will extend the limited supply of H5N1 vaccines in the event of a bird flu pandemic. In preparation for the possibility of an influenza pandemic caused by an H5N1 avian influenza virus that has obtained the ability to be easily transmitted from person to person, several strains of H5N1 viruses have been used to prepare killed-virus vaccines. Vaccine trials in people testing the immunogenicity of these pre-pandemic vaccines have shown that high vaccine doses are required to produce an antibody response that is believed to be protective. In order to lower the dose of vaccine and extend the supply of available vaccine, a number of immune boosters known as adjuvants are being tested. The company said while the principal commercial value of JVRS-100 is as a vaccine by itself, the CDC is testing to see if it could be used to extend the current supply of H5N1 vaccine.

 

Hayward, California-based Kosan Biosciences said it initiated a mid-stage clinical trial of  alvespimycin, the company's second-generation Hsp90 inhibitor, in patients with HER2-positive metastatic breast cancer. Alvespimycin has demonstrated the potential to disrupt the activity of multiple oncogenes and cell-signaling pathways implicated in tumor growth, including HER2, a key signaling pathway in breast cancer, the company said. The objective of the trial is to evaluate the safety and anticancer activity of alvespimycin as a single agent in patients who have not previously received Herceptin for metastatic disease except in an adjuvant setting. Antitumor data in patients with advanced HER2-positive cancer presented at the September 2007 American Society of Oncology Breast Cancer Symposium demonstrated encouraging antitumor activity of alvespimycin in combination with trastuzumab (Herceptin).

 

Paris-based Ipsen and The Salk Institute for Biological Studies in La Jolla, California said that they will be signing a memorandum of understanding setting the framework for the creation of the Ipsen Life Sciences Program at The Salk Institute. The mission of the partnership is to advance knowledge in the field of proliferative and degenerative diseases through fundamental and applied biology research. The program will sponsor programs for up to five years and focus on such areas as the contribution of chronic inflammation to malignant diseases such as cancer, loss of cognitive functions, movement disorders, and metabolic syndromes.

 

Thousand Oaks, California-based Amgen and Wyeth Pharmaceuticals said data from a late-stage trial showed that children and adolescents with moderate to severe plaque psoriasis who received treatment with Enbrel experienced significant improvements in the signs and symptoms of their disease. The study, published in The New England Journal of Medicine, found 57 percent of the patients achieved a 75 percent or greater improvement from baseline at 12 weeks. At 36 weeks, the number grew to 68 percent. Amgen has filed a supplemental Biologics License Application with the U.S. Food and Drug Administration for the use of Enbrel in treating pediatric patients with chronic moderate to severe plaque psoriasis who have tried another therapy. According to the National Institutes of Health, up to 7.5 million Americans have psoriasis, a non-contagious, chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Approximately 80 percent of these patients have plaque psoriasis, which is characterized by painful and itchy, red, scaly patches.

OSTEOPOROSIS: LIGAND AND PFIZER SEEK FDA APPROVAL FOR FABLYN
San Diego-based Ligand Pharmaceuticals said that its partner Pfizer has submitted an application with the U.S. Food and Drug Administration to market Fablyn tablets (formerly Oporia), a selective estrogen receptor modulator for the treatment of osteoporosis in postmenopausal women. The Ligand-Pfizer collaboration was formed to develop therapies for osteoporosis and subsequently produced lasofoxifene tartrate, an estrogen partial agonist for osteoporosis treatment and other diseases. Pfizer is responsible for the registration and worldwide marketing for Fablyn. Ligand is entitled to a milestone payment upon FDA approval, and would also receive royalty payments equal to 3 percent of net sales. In August 2004 Pfizer filed an application with the FDA for the use of Fablyn in the prevention of osteoporosis. An additional application was filed in December 2004 for the treatment of vaginal atrophy. Pfizer received "not-approvable" letters from the FDA for Fablyn for the prevention of post-menopausal osteoporosis in September 2005 and for the treatment of vaginal atrophy in January 2006.