SciClone and Sigma-Tau complete enrollment of Phase III hepatitis C trial

Jun 27, 2008 (Datamonitor via COMTEX) -- SCLN | Quote | Chart | News | PowerRating -- SciClone Pharmaceuticals and Sigma-Tau have announced that all 553 enrolled patients successfully completed a Phase III trial.

After 48 weeks of therapy, all patients responding to treatment have now completed their 24-week follow-up. The unblinded data from the trial are expected to be available in the fourth quarter of 2008.

The Phase III trial is evaluating Zadaxin (thymalfasin) in combination with pegylated interferon alpha and ribavirin as a treatment for patients with hepatitis C virus (HCV) who have not responded to prior therapy with pegylated interferon alpha and ribavirin.

In February 2008, SciClone and Sigma-Tau have announced promising blinded interim data from this trial. The treatment approach for HCV using a combination of thymalfasin together with pegylated interferon plus ribavirin is patent protected by SciClone in most major markets including the US and Europe until 2021.

Mario Rizzetto, lead investigator of the trial, said: "The completion of the study is an important step toward unblinding the data. Previously reported data from this Phase III hepatitis C trial have been promising. The standard data review and analysis is underway with an unblinding of the data expected in late 2008."

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