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Biogen Idec and Roche Meet Primary Endpoint on Phase III Study into Rheumatoid Arthritis Treatment
Biogen Idec (NASDAQ: BIIB) and Roche Group (OTC: RHHBY, SIX: RO) subsidiary Genentech announced their Phase III study into a treatment for rheumatoid arthritis (RA) patients had met its primary endpoint.
Rheumatoid Arthritis is a debilitating auto-immune disease that affects an estimated 1.3 million Americans. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation and irreversible damage. The disease often results in disability.
"These results are significant because they are the first data from a large Phase III trial to show that a humanized antibody targeted at B-cells improves the signs and symptoms of rheumatoid arthritis", Genentech’s chief medical officer, Hal Barron, M.D commented, "These results build on earlier findings from our broad clinical program”.
Ocrelizumab is an investigational humanized monoclonal antibody. According to the treatment’s development partners, Ocrelizumab selectively binds to and eliminates a particular protein, which is believed to play a critical role in immunologic diseases. Subsequently allowing healthy cells to regenerate after treatment and eventually return to normal levels.
The primary endpoint was to determine the proportion of patients with improving signs and symptoms (as measured by American College of Rheumatology) at week 24 and week 48. The results of three other Phase III studies investigating the use of ocrelizumab in RA are expected in the first half of 2010.