Genentech's Rituxan Fails in MS Trial

A Phase II/III clinical trial of Rituxan to treat primary-progressive multiple sclerosis (PPMS) failed, according to the sponsoring companies.

The trial did not meet its primary endpoint “as measured by the time to confirmed disease progression during the 96-week treatment period,” Hal Barron, Genentech senior vice president, said. However, he added, “there was some evidence of biologic activity.” Genentech and Biogen Idec, the sponsors, will continue to review the data.

The Phase II/III randomized, double-blind, placebo-controlled, multicenter study was designed to evaluate the efficacy, safety and tolerability of four courses of Rituxan (rituximab) in 439 patients with PPMS. Patients received four treatment courses of Rituxan six months apart or placebo. Serious adverse events were 16.4 percent in the Rituxan arm compared with 13.6 percent in the placebo arm.
 
Rituxan also is being studied in other autoimmune diseases, including systemic lupus erythematosus, lupus nephritis and antineutrophil cytoplasmic antibodies-associated vasculitis.