Makers of Rituxan announce phase III failure as MS treatment

SAN DIEGO The cancer drug Rituxan, marketed by Genentech and Biogen Idec has failed to show that it is an effective treatment for primary-progressive multiple sclerosis. The drug failed during a phase III clinical trial.

Rituxan is approved for use as a treatment for non-Hodgkin’s lymphoma and rheumatoid arthritis.

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 will continue to review the data.

The phase III randomized, placebo-controlled study was designed to evaluate the efficacy, safety and tolerability of four courses of Rituxan in 439 patients with PPMS. Patients received four treatment courses of Rituxan six months apart or placebo. Serious adverse events were found in 16.4 percent of the Rituxan arm compared with 13.6 percent in the placebo arm.