Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) recently announced the positive results of a Phase II study of Rituxan® (Rituximab) for relapsing-remitting multiple sclerosis (RRMS).
RRMS, the most common form of MS (a chronic autoimmune disease in which the immune system is thought to attack the body's own myelin, a fatty substance that surrounds and protects the nerve fibers of the brain, optic nerves and spinal cord) accounts for about 65% of all MS cases and is characterized by acute exacerbations with full or partial recovery between attacks.
In the said study, 104 patients treated with Rituxan® showed a statistically significant reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24 as compared to placebo.
Discovered by Biogen Idec, Inc., Rituxan® is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells."These initial results exceeded our expectations," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "Showing a significant benefit at 24 weeks in this small Phase II trial supports our hypothesis that selective B-cell targeted therapy may play an important role in the treatment of MS."
"Biogen Idec is committed to offering multiple options for people living with MS, a devastating disease. We are very encouraged by these data and look forward to learning more about the potential of Rituxan as a therapy to treat MS," said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec.
Rituxan® was first approved by the USFDA in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma.
Approved in the EU under the trade name MabThera® in June 1998, Rituxan® has been USFDA approved in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients, including combination with methotrexate to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.
Currently, Rituxan® is being studied in primary progressive multiple sclerosis (MS) in addition to RRMS and also other autoimmune diseases with significant unmet medical needs like systemic lupus erythematosus, lupus nephritis and ANCA-associated vasculitis.
In the , Rituxan® is being co-marketed by Genentech, Inc. and Biogen Idec, Inc. while Roche (OTC: RHHBY) markets it under the trade name MabThera® to the rest of the world except Japan where Chugai and Zenyaku Kogyo Co. Ltd. co-markets.
To get a copy of Rituxan®’s full prescribing information (including Boxed Warning) you may call 1-800-821-8590 or download from the website.
Source: Genentech, Inc.
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