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news.SciClone Pharmaceuticals and Sigma-Tau have reported promising blinded interim data from a large, randomized Phase III clinical trial evaluating Zadaxin 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.
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The interim blinded HCV data showed that at the end of 48 weeks of therapy, 171 out of 553 total patients, including both treatment and control group patients, responded to treatment. A response to treatment is defined as having no detectable HCV RNA circulating in the blood at the end of 48 weeks of therapy.
Of the 171 patients who responded after 48 weeks of therapy, 150 patients have completed the 24-week follow up period (72 week observation) and 54 patients have achieved a sustained virologic response (SVR). Of the remaining 21 patients who responded at the end of therapy, 12 were HCV negative at week 60 (12-week follow-up observation period), and two had yet to reach the week 60 follow-up point. All patients will complete the observation period by the end of the second quarter 2008. Full unblinded data from the trial will be available in the third quarter of 2008. If the final results of this trial are positive, SciClone and Sigma-Tau plan to meet with the regulatory authorities in the US and Europe to determine the most expeditious process to bring this therapy to the market.
Friedhelm Blobel, president and CEO of SciClone said: “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.”