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Monday, October 24, 2011 10:02:52 AM
Sanofi-Aventis reports Alemtuzumab significantly reduces relapses in multiple sclerosis vs interferon Beta-1a in a Phase III study (SNY) 35.63 : Co and its subsidiary Genzyme announce new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab to Rebif in patients with relapsing-remitting multiple sclerosis. New data show that 78% of patients treated with alemtuzumab remained relapse-free for two years, providing statistically significant improvement over interferon beta-1a (78% vs 59% at two years) and meeting this secondary endpoint. Additional findings from the CARE-MS I study presented today include other secondary endpoints that suggest positive outcomes with alemtuzumab. Improvement in Multiple Sclerosis Functional Composite scores was observed in alemtuzumab-treated patients, as compared to interferon beta-1a (0.12 vs 0.05 mean change from baseline at year two). MSFC is a composite measurement of physical and cognitive function.
1:21AM Biogen Idec and Abbott (ABT) present positive data for Daclizumab HYP from select Phase 2B trial (BIIB) 108.84 : Biogen (BIIB) and Abbott (ABT) announce additional results from the SELECT Phase 2b trial in people with relapsing-remitting multiple sclerosis. Results showed that DAC HYP, administered subcutaneously once every four weeks, met the trial's primary endpoint by significantly reducing the annualized relapse rate by 54% in the 150 mg dose group and 50% in the 300 mg dose group compared to the placebo group at one year. In addition to meeting the primary endpoint, both doses of DAC HYP met key secondary endpoints, including measures of magnetic resonance imaging. In a sub-study for a pre-specified subset of patients, both 150 mg and 300 mg of DAC HYP provided a significant reduction in the cumulative number of new gadolinium-enhancing lesions between weeks eight and 24 (69%; 78%). Both doses also provided a significant reduction in new or newly enlarging T2 hyperintense lesions (70%; 79%). In a tertiary endpoint, both 150 mg and 300 mg of DAC HYP also significantly reduced the number of new Gd+ lesions on the week 52 MRI (79%; 86%).
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