US biotech firm Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN) says that the Phase lll CARE-MS ll trial with its multiple sclerosis drug candidate Lemtrada (alemtuzumab) met both of its co-primary endpoints.
Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab (compared with Merck Serono’s Rebif (44mcg subcutaneous interferon beta-1a), confirming results from the CARE-MS I study released earlier this year (The Pharma Letter October 24).
Results for both of these co-primary endpoints were highly statistically significant. CARE-MS II is the randomized Phase III clinical trial comparing the investigational drug alemtuzumab to interferon beta-1a 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. Genzyme is developing alemtuzumab in MS in collaboration with Bayer HealthCare.
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