SciClone and Sigma-Tau report promising Ph III Zadaxin data

The USA's SciClone Pharmaceuticals and Italy-based Sigma-Tau SpA reported promising blinded interim data from a large, randomized Phase III clinical trial evaluating Zadaxin (thymalfasin) in combination with pegylated interferon alpha and ribavirin as a treatment for patients with hepatitis C virus who have not responded to prior therapy with pegylated interferon alpha and ribavirin. Full unblinded data from the trial will be available in the third quarter of the year. The interim blinded findings show that, at the end of 48 weeks of therapy, 171 out of 553 total patients, including both active and control group subjects, responded to treatment, defined as having no detectable HCV RNA circulating in the blood at the end of 48 weeks of therapy. Of these 171 patients, 150 have completed the 24-week follow up period and 54 have achieved a sustained virologic response. All patients will complete the 12-week follow-up observation period by the end of the second quarter.