Sanofi and its subsidiary Genzyme have reported new results from the CARE-MS I trial, comparing the investigational drug Lemtrada (alemtuzumab) to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS).
The findings from the first of two randomised, Phase III clinical trials showed that 78% of patients treated with alemtuzumab remained relapse-free, and 55% reported a reduction in relapse rate compared to interferon beta-1a over two years of study.
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An improvement in Multiple Sclerosis Functional Composite scores was also observed in alemtuzumab-treated patients, compared with those treated with interferon beta-1a.
Alastair Compston, head of the Department of Clinical Neurosciences at the University of Cambridge in UK, said that the CARE-MS I trial confirmed that patients treated with alemtuzumab showed a reduction in disease activity over the first two years of observation.
"This data support the efficacy profile and potential that alemtuzumab offers for patients with relapsing-remitting MS requiring a more effective option than currently available therapies," Compston added.
The other Phase III trial, CARE-MS II, which is currently underway, is assessing alemtuzumab against interferon beta-1a in relapsing-remitting MS patients, and the results are likely to be published in the fourth quarter of 2011.
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By GlobalDataThe company is planning to register for US and EU approval of alemtuzumab in relapsing MS during the first quarter of 2012.
