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news.Lev Pharmaceuticals has presented encouraging results from a Phase III trial of Cinryze, in patients with acute attacks of hereditary angioedema, a genetic condition that causes recurrent and potentially life threatening inflammation in the larynx, abdomen, face, extremities and urogenital tract.
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The results from this trial showed that patients undergoing a hereditary angioedema (HAE) attack who received treatment with Cinryze saw symptoms begin to fade in a median time of two hours, compared with greater than four hours for patients who received placebo. The findings were statistically significant, Lev said.
The study also met secondary endpoints, with Cinryze treatment significantly better than placebo in providing unequivocal relief within four hours, as well as in complete resolution of the defining symptoms of the attack.
Joshua Schein, Lev’s CEO, siad: “These data, taken together, provide convincing evidence of the efficacy of Cinryze. We look forward to continuing to work with the FDA to bring this breakthrough treatment to patients as soon as possible.”