Cambridge, MA and Dublin, Ireland (January 2, 2003) Biogen, Inc. (NASDAQ:BGEN) and Elan Corporation, plc (NYSE:ELN) announced today that the results of a study published in the New England Journal of Medicine (NEJM) indicate ANTEGREN (natalizumab) reduced new inflammatory brain lesions and relapses in patients with relapsing forms of multiple sclerosis (MS). The use of natalizumab in the treatment of MS is currently being investigated in Phase III clinical trials. An investigational study was also published in today's NEJM that showed promising results for natalizumab on disease remission and improved quality of life for patients with Crohn's disease.
Biogen and Elan are collaborating on the development, manufacturing and commercialization of natalizumab, the first in a new class of compounds known as selective adhesion molecule inhibitors (SAM inhibitors). The findings published in the NEJM are based on a Phase II study conducted and analyzed by Elan and Biogen. The study was a double blind, placebo-controlled trial of 213 MS patients at 26 sites in the U.S., Canada and the U.K. Patients received either one of two natalizumab doses (3 mg/kg or 6 mg/kg) or placebo by intravenous infusion every 4 weeks for 6 months. Participants in the trial had either relapsing-remitting MS or secondary progressive MS.
The primary analysis was based on MRI scans and showed that patients treated with natalizumab for 6 months had up to 93 percent reduction in new gadolinium-enhancing lesions compared to patients treated with placebo. The reduction in lesions was seen as early as one month after the first infusion and was sustained during the treatment period. A mean of 9.6 new enhancing lesions developed during the treatment period in the placebo group (n= 71) versus 0.7 and 1.1 in the 3 mg/kg (n= 68) and 6 mg/kg groups (n=74), respectively.
There was a reduction of approximately 50% in the number of patients experiencing a relapse in the natalizumaPage: 1 2 3 4 Related biology news :1
Contact: Amy Losak
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