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Biogen-Idec's BG-12 Shines At the Top of the Charts in the Treatment of Relapsing-Remitting Multiple Sclerosis
Date:11/4/2011

NEW YORK, Nov. 4, 2011 /PRNewswire/ -- Citeline, an Informa business unit, and the world's leading research authority on pharmaceutical clinical trials recently reviewed results presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), a major multiple sclerosis conference which was held October 19-22, 2011 in Amsterdam.  

Phase III study of oral BG-12 in relapsing-remitting multiple sclerosis sparked excitement as the details of the Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) trial were presented at the meeting, quickly boosting BG-12 to stardom status.

The DEFINE study, supported by Biogen-Idec, showed that 240 mg of BG-12, administered either twice (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with placebo.  It is believed that BG-12 has dual anti-inflammatory and neuroprotective effects via the Nrf2 pathway.  Citeline's analyst Dr. Heidi Chen shared the latest buzz about BG-12 as a promising therapeutic for relapsing-remitting multiple sclerosis patients, "BG-12 offers an attractive package with its distinct and novel mechanism of action, which really adds a sweet edge to the competition."  

BG-12 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2008.  Since the initial results of the DEFINE study were announced in April 2011, BG-12 continues to be a strong contender with its encouraging safety profile.  Dr. Heidi Chen from Citeline noted, "The combined portfolio of efficacy and a robust safety data, BG-12 could become a first line of defense in the treatment of RRMS."  The top-line results of DEFINE trial were replicated in the second pivotal Phase III trial CONFIRM, which significantly reduced annualized relapse
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