Schering AG and Genzyme Announce Interim Results from Trial of Campath for Multiple Sclerosis
Schering AG and Genzyme Corporation announced interim results from a Phase 2 trial comparing Campath® (alemtuzumab) with Rebif® (interferon beta-1a) for the treatment of multiple sclerosis. The results announced derive from a pre-specified efficacy and safety interim analysis conducted after one year of treatment for all patients in the planned three-year trial. This review was conducted in conjunction with an independent data safety monitoring board.
Analysis of the primary endpoints after one year of treatment showed a large treatment effect in favor of alemtuzumab. Review of the data also showed that three confirmed cases of severe idiopathic thrombocytopenic purpura (ITP) occurred in the trial. Based on these results, and after consultation with the U.S. Food and Drug Administration, the companies will continue to collect both efficacy and safety data from this trial while preparing to initiate a Phase 3 trial. Dosing with alemtuzumab in this trial has been suspended while the companies work closely with regulatory authorities and clinical investigators to ensure that a comprehensive approach is in place to manage patient safety. Campath continues to be available in its current labeled indication for the treatment of B-cell chronic lymphocytic leukemia.
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