Genentech and Biogen Idec Announce Positive Results From First Phase III Trial of Ocrelizumab in Rheumatoid Arthritis
SOUTH SAN FRANCISCO, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 11, 2009 - Genentech, Inc. a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today a Phase III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks. Genentech and Biogen Idec continue to analyze the study results and plan to submit the data for presentation at an upcoming medical meeting.
“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,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “These results build on earlier findings from our broad clinical program aimed at developing medicines to help people living with rheumatoid arthritis.”
“Patients living with a debilitating disease like rheumatoid arthritis can benefit from additional treatment options. We look forward to seeing the results of our ongoing Phase III rheumatoid arthritis trials with ocrelizumab,” said David Hagerty, M.D., vice president and chief medical officer, Rheumatology, Biogen Idec.
STAGE is a Phase III, international, randomized, multicenter, three-arm, parallel-group, placebo controlled study in 1,015 patients with active RA with an inadequate response to prior treatment with MTX. The study consisted of a 48-week double-blind treatment period and study extension period of at least 48 weeks. The primary endpoint was to determine the proportion of patients with an ACR20 response at week 24 and week 48. Patients received two courses at six-month intervals of either one of two different doses of ocrelizumab or placebo by intravenous infusion on Day 1 and Day 15, with weekly MTX as a background therapy. Results of three other Phase III studies investigating the use of ocrelizumab in RA are expected in the first half of 2010. As previously announced, the FILM study in MTX-naïve RA patients was placed on clinical hold and dosing was stopped.
While overall adverse events were comparable between ocrelizumab and placebo treatment groups, a higher percentage of serious infections was observed in the pooled ocrelizumab groups when compared to the placebo group. Safety analyses from the study are ongoing and will be presented at an upcoming medical meeting.
Ocrelizumab is an investigational humanized monoclonal antibody that selectively binds to a particular protein - the CD20 antigen - on the surface of B-cells, which are believed to play a critical role in immunologic diseases. Ocrelizumab binds to and eliminates CD20-positive B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and eventually return to normal levels. Ocrelizumab is also being studied in patients with multiple sclerosis.
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation, irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics to treat patients with serious or life-threatening medical conditions. The company, a wholly owned member of the Roche Group, has headquarters in South San Francisco, Calif. For additional information about the company, please visit http://www.gene.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
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Posted: December 2009