Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple...( CAMBRIDGE Mass. and BERLIN Sept. ...),Health

CAMBRIDGE, Mass., and BERLIN, Sept. 26 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).

The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif(R) (interferon beta-1a) in patients with relapsing- remitting multiple sclerosis (MS). Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but who have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.

Initiation of this Phase 3 program follows the successful completion of the initial treatment period in the Phase 2 trial. Interim results from the Phase 2 trial indicated that alemtuzumab-treated patients experienced a statistically significant reduction compared with Rebif-treated patients in the risk for sustained accumulation of disability and the risk for relapse for 24 months. Results of the primary outcomes from this trial at 36 months are expected to be presented on Oct. 14 by Professor Alastair Compston during the Charcot Award lecture at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis, in Prague.

The CARE-MS I study will enroll up to 525 patients at approximately 60 med
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