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Lev Pharmaceuticals Completes Phase III Prophylaxis Trial of,C1-Esterase Inhibitor for Hereditary Angioedema

NEW YORK, May 31, 2007 /PRNewswire-FirstCall/ -- Lev Pharmaceuticals, Inc. ("Lev" or the "Company") announced today that it has completed patient treatment in the prophylactic portion of its Phase III clinical trial of C1-esterase inhibitor (C1-INH) for hereditary angioedema (HAE). The clinical trial, designated CHANGE, examined and evaluated the efficacy and safety of C1-INH replacement therapy in treating acute HAE attacks and as prophylactic treatment to prevent HAE attacks.

Lev previously announced that its protocol-defined primary endpoint was achieved for the acute portion of the CHANGE study. The results indicated a clinically and statistically significant reduction in the time to sustained relief of acute HAE symptoms. HAE, or hereditary C1-inhibitor deficiency, is a rare and life-threatening inflammatory condition for which there is currently no FDA-licensed acute therapy in the United States.

"We are pleased to complete the prophylactic portion of the study ahead of schedule. The rapid enrollment and commitment of patients in the study reflects the need for an effective and safe prophylactic treatment for HAE," said Jason Bablak, the Company's Vice President, Regulatory Affairs and Product Development. "As the only company with a clinical development program for HAE prophylaxis, we look forward to expanding the treatment options for HAE patients."

The prophylactic segment of the CHANGE study was a placebo-controlled, double-blind, multi-center, crossover trial designed to determine the efficacy of C1-INH in preventing the onset of HAE attacks. In the study, 24 patients were randomly assigned to one of two treatment groups: C1-INH followed by placebo or placebo followed by C1-INH. Each patient received twice-weekly treatment with C1-INH for a 12-week period and twice-weekly treatment with placebo for a 12-week period. The final results of the prophylactic study are expected to be a
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