CLICK: "Genentech and Biogen Idec Announce Positive Results From a Phase 2 Trial of Rituxan in Relapsing-Remitting Multiple Sclerosis"

Genentech and Biogen Idec Announce Positive Results From a Phase 2 Trial of Rituxan in Relapsing-Remitting Ms
"Genentech, Inc. and Biogen Idec, Inc. announced today that a phase 2 study of Rituxan(R) (Rituximab) for relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint. The study of 104 patients 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 in the Rituxan-treated group compared to placebo. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.

This phase 2 randomized, double-blind, parallel-group, placebo-controlled, multi-center study was designed to evaluate safety and efficacy of Rituxan in adults with RRMS. A total of 104 patients at 48 sites in the U.S. and Canada were randomized to receive either a single treatment course of Rituxan or placebo. Gadolinium-enhancing lesions visible by MRI scans were assessed at 12, 16, 20 and 24 weeks. Patients will continue to be followed for 48 weeks.

"These initial results exceeded our expectations," said Hal Barron, MD, Genentech senior vice president, development and chief medical officer. "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."