Genentech And Biogen Idec Announce Top-Line Results From A Phase II/III Clinical Trial Of Rituxan In Primary-Progressive Multiple Sclerosis
"We are disappointed in the outcome of the primary endpoint, but not surprised given the significant clinical challenges presented by PPMS," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "There was some evidence of biologic activity, and we will continue to review all the data to better understand the role of B cells in MS."
"While the primary results are not what we had hoped, we continue to believe in the potential of B cell therapy for patients living with MS," said Michael Panzara, M.D., MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec. "PPMS is widely considered a difficult form of MS to treat and historically no therapy has proven efficacy in this disease state."
About the Study
This Phase II/III randomized, double-blind, placebo-controlled, multi-center study was designed to evaluate the efficacy, safety and tolerability of four courses of Rituxan in patients with PPMS. A total of 439 patients from approximately 60 sites in the U.S. and Canada were randomized 2:1 to receive either four treatment courses of Rituxan six months apart or placebo. MRI evaluations were conducted at baseline, weeks 6, 48, 96 and 122.
Detailed safety data from the study is currently being evaluated. The incidence of overall adverse events was comparable between Rituxan and placebo treatment groups. Serious adverse events were 16.4 percent in the Rituxan arm versus 13.6 percent in the placebo arm, with an incidence of serious infections of 4.5 percent compared with
Genentech ªi Biogen Idec Anunþarea Top-Line rezultate de la un studiu de faza II / III, studiu clinic Din Rituxan În primar-progresivã scleroza multiplã - Genentech And Biogen Idec Announce Top-Line Results From A Phase II/III Clinical Trial Of Rituxan In Primary-Progressive Multiple Sclerosis - articole medicale engleza - startsanatate