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news.Lev Pharmaceuticals has reported encouraging results from a phase III trial examining the safety and efficiency of its C1-esterase inhibitor for the acute treatment of a rare inflammatory condition.
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In the study, the inhibitor produced a clinically and statistically significant reduction in the time to sustained relief for acute hereditary angioedema (HAE) symptoms. Based on the positive results of this study, the company intends to submit a biologics license application to the FDA in the second quarter of 2007.
The phase III study examined C1-INH in patients suffering from moderate to severe acute HAE attacks in the face, abdomen or genitals. The primary endpoint was met with a median time to sustained symptom relief of 2 hours for patients receiving C1-esterase inhibitor (C1-INH) compared to greater than 4 hours, the maximum evaluation period, for patients receiving placebo.
Sustained symptom relief was defined as subject-reported symptom relief at three consecutive 15 minute intervals following treatment. In the study, C1-INH was effective as analyzed across all attack sites.
In addition to the acute study, a second phase of the trial is examining the prophylactic use of C1-INH in preventing HAE attacks in more severely affected patients. This prophylactic study is ongoing and is expected to conclude in the second half of 2007. There is currently no FDA-licensed acute therapy in the US for the treatment of HAE.