GENENTECH, BIOGEN IDEC REPORT POSITIVE RESULTS IN MS STUDY

Genentech and Biogen Idec announced that a Phase II study of Rituxan (Rituximab) for relapsing-remitting multiple sclerosis (MS) 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 with the placebo group.

This randomized, double-blind, parallel-group, placebo-controlled, multicenter study was designed to evaluate safety and efficacy of Rituxan in adults. Patients will continue to be followed for 48 weeks.

Rates of overall adverse events and serious adverse events were comparable between the two treatment groups. The overall rates of infection were comparable among the two treatment groups, with an increase in the rates of nasopharyngitis, upper respiratory tract infections, urinary tract infections and sinusitis in the Rituxan-treated patients.

Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells. In addition to relapsing-remitting MS, Rituxan is being studied in primary progressive MS. Rituxan is also being studied in other autoimmune diseases, including systemic lupus erythematosus, lupus nephritis and ANCA-associated vasculitis.