SciClone's hep C drug fails late-stage trial

SciClone Pharmaceuticals' late-stage therapy for hepatitis C failed to hit a primary endpoint in a late-stage trial. The drug, thymalfasin, failed to register a significant response in patients who had not responded to a combination of pegylated interferon alpha and ribavirin--standard treatments in use today. The drug is partnered with Sigma-Tau.

In a smaller portion of the trial, though, researchers said the drug demonstrated efficacy against hepatitis C. For "patients who completed the full course of 48 weeks of treatment with thymalfasin in addition to peg-IFN-2a and RBV, the primary endpoint achieved statistical significance."

"We are disappointed that the study did not reach its primary efficacy endpoint in the intent-to-treat population," said CEO Friedhelm Blobel, Ph.D., 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."

"These data suggest that the immunomodulatory activity of thymalfasin may play an important role in maintaining the viral response in patients who completed the full prescribed 48 weeks of treatment," said Israel Rios, MD, chief medical officer of SciClone. "Although the safety analyses are still ongoing, thymalfasin appeared to be well tolerated. During the course of the trial the side effects reported were those usually associated with the use of interferon and ribavirin."

- read SciClone's release
- check out the AP report

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SciClone report positive hep C data