Rituxan Trial Fails to Meet Primary Endpoint

Genentech and Biogen Idec’s Phase II/III study of Rituxan in patients with primary-progressive multiple sclerosis did not meet its primary endpoint, which was time to confirmed disease progression during the 96-week treatment period.

The randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy, safety and tolerability of four courses of Rituxan (rituximab) in 439 patients.

The overall adverse event rates were 16.4 percent for Rituxan compared with 13.6 percent for placebo. Most events in the Rituxan arm were mild to moderate. But events of greater severity were reported more frequently in patients receiving Rituxan, Genentech said.

The companies will analyze the study results and submit the data for presentation at an upcoming medical meeting.