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CONFIRM – Second phase III trial results for BG-12

 

REPORT FROM THE 25TH CONGRESS OF THE EUROPEAN COMMITTEE FOR TREATMENT AND RESEARCH IN MULTIPLE SCLEROSIS (ECTRIMS) – AMSTERDAM, THE NETHERLANDS, OCTOBER 19-22, 2011 – Just days after ECTRIMS, top-line  results from the second of two phase III trials of BG-12 were announced in a press release (www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1621631) and in a webcast to investors (www.biogenidec.com/investors.aspx?ID=5494).

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No benefit with simvastatin add-on therapy in MS

 

The most recent results from the SIMCOMBIN trial of combined beta-interferon and simvastatin, an HMG CoA reductase inhibitor, indicate that there is no beneficial effect with add-on therapy (Sorensen et al. Lancet Neurol 2011; 10: 691-701).

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No effect of cholesterol reduction on AD measures

 

A number of early reports suggested that the risk of AD was reduced in patients taking an HMG CoA reductase inhibitor (statin) (Wolozin et al. Arch Neurol 2000; 57: 1439-1443, free full text at http://archneur.ama-assn.org/cgi/reprint/57/10/1439; Rockwood et al. Arch Neurol 2002; 59: 223-227, free full text at http://archneur.ama-assn.org/cgi/reprint/59/2/223).

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A rationale was that statins reduced beta-amyloid formation in the CNS (Fassbender et al. PNAS USA 2001; 98: 5856-5861, free full text at www.ncbi.nlm.nih.gov/pmc/articles/PMC33303/pdf/pq005856.pdf; Sjogren et al. Dement Geriatr Cogn Disord 2003; 16: 25-30).

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CNS drug development: a pipeline of problems

 

New drug development in neurology and psychiatry is approaching a state of crisis due to the failure of numerous compounds in recent years, the cost of bringing new products to market, and pharmaceutical companies abandoning their CNS drug research programs, according to reports from the U.S. and Europe.

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