Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology ( Rituxan Significantly Reduced Signs of ...)

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Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology

Rituxan Significantly Reduced Signs of Disease Activity as Measured by MRI and Relapse --

BOSTON -- May 1, 2007 -- Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced that positive data from a Phase II clinical study of Rituxan® (rituximab) in patients with relapsing-remitting multiple sclerosis (RRMS) were presented today at the American Academy of Neurology annual meeting held in Boston. Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells.

"There remains a great need for safe and effective treatments for patients with RRMS,"said Stephen Hauser, MD, Professor and Chair, Department of Neurology, University of California, San Francisco. "These Phase II results are very encouraging and suggest B-cells play a key role in MS. They also lend support to the concept that selective targeting of B-cells may be an important approach to treating this debilitating disease."

In this Phase II double-blind, placebo-controlled study that evaluated the safety and efficacy of Rituxan in adult patients with RRMS, 104 patients were randomized to receive either a single treatment course of Rituxan (two infusions separated by two weeks) or placebo. The primary endpoint was defined as the total number of gadolinium-enhancing T1 lesions at weeks 12, 16, 20 and 24, as measured by serial MRI scans of the brain. The total number of gadolinium lesions at weeks 12, 16, 20 and 24 was statistically significantly reduced in patients receiving Rituxan compared to those receiving placebo (p<0.0001). At week 24, the total cumulative mean number of gadolinium lesions per patient was reduced by 91 percent, to 0.5 in the Rituxan-treated group from 5.5 in the placebo group.

In addition, the proportion of patients with relapses over 24 weeks in the Rituxan-treated arm was 14.5 percent compared to 34.3 percent in the
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( Rituxan Significantly Reduced Signs of ...)Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology,Health