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SciClone Zadaxin fails Phase III hep C trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

SciClone's immunomodulatory agent Zadaxin (thymalfasin) fails to demonstrate a statistically significant benefit in combination with pegylated interferon alpha for treatment of refractory hepatitis C, the firm announces Dec. 14. The 48-week trial is the first of two U.S. Phase III studies looking at Zadaxin in combination with peg-interferon alpha; sustained viral response (SVR) was the primary endpoint. "Although not statistically significant, 4% (10/269) of patients treated with Zadaxin plus pegylated interferon alpha achieved an SVR compared with only 2% (5/265) of patients treated with pegylated interferon alone," SciClone says. An ongoing Phase III triple therapy trial looking at the peg-interferon regimen plus ribavirin is being conducted by SciClone's European partner Sigma-Tau...
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