Phase 3 Study Update of Lemtrada for Multiple Sclerosis
Genzyme, a Sanofi company, announced results from its Phase 3 CARE-MS II trial of Lemtrada (alemtuzumab) for the treatment of multiple sclerosis. CARE-MS II is a randomized trial comparing alemtuzumab to interferon beta-1a (Rebif; EMD Serono, Inc.) in patients with relapsing-remitting multiple sclerosis (RRMS). Patients were required to have experienced a relapse while on a prior therapy to be eligible for CARE-MS II.
CARE-MS II met both of its co-primary endpoints, relapse rate and sustained accumulation (worsening) of disability (SAD). A 49% reduction in relapse rate was observed in patients treated with alemtuzumab 12mg compared to interferon beta-1a over two years of study (P<0.0001). Importantly, there was also a 42% reduction in the risk of SAD as measured by the Expanded Disability Status Scale (EDSS) (P=0.0084). Analysis of the full CARE-MS II data is ongoing.
Alemtuzumab, a humanized monoclonal antibody, targets the cell-surface glycoprotein CD52, which is highly expressed on T- and B-lymphocytes. Preliminary research suggests that alemtuzumab initially depletes the T- and B-cells that may be responsible for the cellular damage in MS. This depletion of T- and B-cells is followed by a distinctive pattern of lymphocyte repopulation.
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