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Top-Line Efficacy Data Presented from Phase 2 Trial of Alemtuzumab in Multiple Sclerosis
Date:10/15/2007

, rater-blinded study that will compare alemtuzumab to Rebif(R) as first-line therapy for patients with relapsing-remitting multiple sclerosis (MS). The second Phase 3 study, CARE-MS II, also has begun and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.

Phase 2 Trial Design

The phase 2 trial randomized 334 patients with active relapsing-remitting multiple sclerosis at 49 medical centers in Europe and the United States. Patients in the trial were treated with alemtuzumab at one of two doses (12 or 24/mg per day intravenously for five days at initial treatment, and three days of re-treatment after 12 months with an option to treat again at 24 months), or interferon beta-1a (44 mcg administered by subcutaneous injection three times per week, as indicated in its product label).

The randomized trial compared the efficacy of alemtuzumab with interferon beta-1a using two primary endpoints: the rate of relapse of MS symptoms, and the time to Sustained Accumulation of Disability over six months as measured by Expanded Disability Status Scale [EDSS]. Efficacy assessments were made by independent neurologists blinded to therapy.

Alemtuzumab is an investigational drug for the treatment of MS and must not be used outside of a formal clinical trial setting in MS patients. Physicians or patients seeking additional information about the recently-initiated CARE-MS I Phase 3 trial should contact Genzyme Medical Information at 1-800-745-4447, option 2 in the United States, + 31 35 6991499 in Europe, or visit http://www.clinicaltrials.gov.

About Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic, debilitating disease in which the immune system attacks the person's brain and spinal cord. The disease causes a wide range of symptoms including fatigue, difficulty walking, numbness, and vision problems, and can pr
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SOURCE Genzyme Corporation
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