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C5 Inhibitor Shows Biological Efficacy In Heart Surgery Patients NEW HAVEN, CONN. -- July 28, 1997 -- Scientists at Alexion Pharmaceuticals, Inc. successfully concluded a Phase I/II trial of an experimental drug, the C5 Inhibitor 5G1.1-SC, which showed that the drug was well tolerated and had biological efficacy in patients undergoing cardiopulmonary bypass (CPB). Based on the results of that trial, the U.S. Food and Drug Administration (FDA) granted approval to start a Phase IIa clinical trial for CPB. The primary objective of the Phase I/II clinical trial was to examine the safety of 5G1.1-SC in patients undergoing CPB. The drug was administered in a placebo-controlled manner to 17 patients undergoing CPB at one of four doses, 0.2 mg/kg, 0.5 mg/kg, 1.0 mg/kg or 2.0 mg/kg. The interim analysis shows that the drug was well tolerated. Secondary objectives of the study included an assessment of the biological effects of the drug in thetargeted patient population. In patients undergoing CPB, complement in the patient's blood is pathologically activated during the procedure and 5G1.1-SC directly and selectively blocked the generation of the activated disease-causing byproducts of complement in a dose-dependent manner. Treatment with 5G1.1-SC reduced the more than 10-fold increase in the level of activated complement byproducts experienced by patients on placebo during CPB. The placebo-associated increase was reduced by 33% (p=NS) with 0.2 mg/kg, 77% (P<.05) with 0.5 mg/kg, 99% (P<.01) with 1.0 mg/kg, and 100% (P<.01) with 2.0 mg/kg of 5G1.1-SC. In a statement, the company said their lead product, 5G1.1-SC, potently and selectively inhibits the generation of pathologic complement byproducts, a widely accepted marker for bioincompatibility of bypass procedures, in patients undergoing CPB procedures. The company believes this is the first direct evidence that any drug selectively and potently inhibits the actual pathologic activation of complement in patients. The Company's Phase IIa study will include up to 18 patients undergoing heart surgery at two clinical sites and is expected to gather additional information regarding the biological effects of the 1.0 and 2.0 mg/kg doses vs. placebo. The company plans to follow this study with a larger Phase II study. Alexion's C5 Inhibitors are specific and potent recombinant drugs which are designed to intervene in the complement cascade. The company believes that these proprietary C5 Inhibitors intervene at an optimal point which generally preserves the normal disease-preventing functions of complement proteins while generally inhibiting the disease-causing actions. 5G1.1-SC is a novel single chain antibody, specifically designed to rapidly penetrate tissue and limit inflammation. In preclinical studies, 5G1.1-SC demonstrated its ability to substantially prevent the activation of complement and the subsequent inflammatory process that occurs during CPB. Further, in preclinical studies presented at the American College of Cardiology in March, Alexion's C5 Inhibitors were demonstrated to substantially reduce the myocardial infarction associated with coronary ischemia. According to the most recent statistics available from the American Heart Association, there are in the U.S. approximately 450,000 CPB surgical procedures performed and 1,000,000 patients suffering a myocardial infarction on an annual basis. E-mail this page to a friend or colleague! To print, use this version