Singapore, Feb 12, 2008: Us-based SciClone Pharmaceuticals and Japan’s Sigma-Tau have 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 (HCV) 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 2008.

 

The interim blinded HCV data show 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 therapy.

 

Of the 171 patients who responded after 48 weeks of therapy, 150 patients have completed the 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. While these data include both treatment and control group patients, SciClone and Sigma-Tau believe the trend is promising in light of other recent clinical trial results in non-responder HCV patients retreated with only pegylated interferon alpha and ribavirin that demonstrated SVR rates of 3 to 8 percent at the 72 week observation point. 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.

 

"These interim HCV data are promising because, although we do not know the breakdown between thymalfasin treated and control group patients who have achieved an SVR, this is already a strong overall response for nonresponder patients. We look forward to reporting full data from this trial in the third quarter of 2008," said Dr Mario Rizzetto, Professor of Gastroenterology, San Giovanni Battista Hospital, University of Torino, Italy, and lead investigator of the trial. "Thymalfasin's mechanism of action as an immune stimulator may prove to be ideal in the treatment of chronic hepatitis C, where the immune system is suppressed and cannot effectively fight the disease on its own," He added.