SciClone hepatitis C drug fails late-stage study

FOSTER CITY, Calif. - Biotechnology company SciClone Pharmaceuticals Inc. and partner Sigma-Tau S.p.A. said Wednesday their hepatitis C drug candidate failed to meet its treatment goal in part of a late-stage study.

The companies said thymalfasin did not prompt a response in patients who had previously been treated with a combination of pegylated interferon alpha and ribavirin. Those two drugs are often used to treat hepatitis C, a blood-borne virus that affects the liver.

The late-stage, or Phase III clinical trial involved 552 patients either receiving thymalfasin or placebo. All were also given combinations of pegylated interferon alpha and ribavirin.

In a smaller portion of the study involving 182 patients, the company said the drug did meet its goal of treating hepatitis C. That group of patients completed the full 48-week treatment course.

"We are disappointed that the study did not reach its primary efficacy endpoint in the intent to treat population.," said President and Chief Executive, in a statement. "Nevertheless, the data seen in the completer population suggest a potential benefit of using thymalfasin in patients who completed the full course of treatment."

Thymalfasin is already approved in several countries outside the U.S. under the brand name Zadaxin for a range of conditions, including hepatitis B and hepatitis C.

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