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New Form Of Targeted Antibody Therapy Offers Further Hope To Patients With Incurable HER2-positive Breast Cancer
Final results from a phase II study presented at ASCO show that 25% of women with advanced HER2-positive breast cancer experienced significant shrinkage of their tumours, when treated with a first in class combination antibody called trastuzumab-DM1 (T-DM1). T-DM1 potentially represents another option for patients with metastatic disease, for which there is no cure.
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International Team Of Physician-astronauts Draws Upon First-hand Space Flight Experience In CMAJ Article
An international team of astronauts, including Canadian Dr. Robert Thirsk who launched into space on May 27, have just published an article in the Canadian Medical Association Journal (CMAJ) about the complex physiologic changes and psychological effects that occur in space. They draw upon first-hand experience as both physician-astronauts and crew medical officers on space missions and from NASA literature and peer-reviewed medical s.
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Biological Markers Identified That May Indicate Poor Breast Cancer Prognosis
A team of researchers has found an association between breast cancer survival and two proteins that, when present in the blood in high levels, are indicators of inflammation. Using data from the Health, Eating, Activity and Lifestyle (HEAL) study sponsored by the National Cancer Institute, part of the National Institutes of Health, the researchers found that breast cancer patients with elevated levels of C-reactive protein (CRP) and serum amyloid A (SAA) were approximately two to three times more likely to die sooner or have their cancer return than those patients who had lower levels of these proteins, regardless of the patient"s age, tumor stage, race, body mass index, or history of previous cardiovascular issues. The results of this study were published online, May 26, 2009, in the Journal of Clinical Oncology.
Medical Devices

POZEN Submits New Drug Application For VIMOVO™ (PN 400)

POZEN Inc. (NASDAQ:POZN), announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO™ (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers. The NDA submission is based on data from a comprehensive clinical trials program. POZEN conducted two pivotal studies (301/302) under a special protocol assessment agreed with the FDA, which met their primary endpoints. In the 301/302 studies, significantly fewer subjects taking VIMOVO experienced endoscopically confirmed gastric ulcers compared to subjects receiving EC naproxen. The primary endpoint was the cumulative incidence of gastric ulcers through six months. In each of the trials, approximately 400 subjects received either VIMOVO or EC naproxen (500 mg), twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months. Upon the FDA"s acceptance for filing of the NDA, a $10 million milestone payment from AstraZeneca will be payable to POZEN. About Osteoarthritis Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain, affecting nearly 140 million individuals worldwide,1 and impacting approximately 18% of women and 9.6% of men aged 60 and above.2,3 A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity and muscle weakness.4 Osteoarthritis commonly affects the hands, feet, spine or large weight-bearing joints, such as the hips and knees.5 In the U.S., the average direct cost of osteoarthritis is about $2,600 per year out-of-pocket expenses. Total annual disease costs are $5,700 (2000) and job-related osteoarthritis costs are $3.4 to $13.2 billion per year.6 POZEN


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