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Alexion Unveils Plans for Cardiopulmonary Bypass Trial
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Business New Haven
11/26/2001
By: BNH
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CHESHIRE - On November 13, Alexion Pharmaceuticals Inc. (NASDAQ: ALXN) confirmed that it is preparing to initiate a Phase III clinical trial of pexelizumab in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). The Phase III trial will assess the safety and efficacy of pexelizumab in reducing the combined incidence of death and myocardial infarction in this patient population. The Phase III program, if successful, is expected to be sufficient to support registration. The determination to prepare the Phase III trial follows discussion with the Food and Drug Administration held by Alexion and Procter & Gamble Pharmaceuticals, its partner in the development of pexelizumab.
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