Genentech and Biogen say phase 2 study of Rituxan for MS met primary endpoint

By Lisa Kerner

Charlotte, N.C., Aug. 28 - Genentech, Inc. and Biogen Idec, Inc. said a phase 2 randomized study of the therapeutic antibody Rituxan (rituximab) in 104 patients with relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint, reducing the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24 in the Rituxan-treated group compared to the placebo.

The companies plan to submit the analyzed data at an upcoming medical meeting.

"These initial results exceeded our expectations," Genentech senior vice president, development and chief medical officer Hal Barron said in a company news release.

"Showing a significant benefit at 24 weeks in this small phase 2 trial supports our hypothesis that selective B-cell targeted therapy may play an important role in the treatment of MS."

While rates of overall adverse events and serious adverse events were comparable between the two treatment groups, serious infectious adverse events occurring in Rituxan-treated patients included gastroenteritis and bronchitis, according to the release.

MS, a chronic autoimmune disease, is the leading cause of neurological disability in young adults. RRMS accounts for approximately 65% of all MS cases.

Rituxan, discovered by Biogen Idec, was approved by the Food and Drug Administration in 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma.

Genentech is a biotechnology company located in South San Francisco, Calif.

Cambridge, Mass.-based Biogen develops novel therapies for use in oncology, neurology and immunology.

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