SciClone Pharmaceuticals, Inc. and Sigma-Tau S.p.A. announced results from a large, randomized, phase 3 clinical trial evaluating thymalfasin in combination with pegylated interferon alpha-2a (peg-IFN-2a) and ribavirin (RBV) as a treatment for patients with hepatitis C virus (HCV) who have not responded to prior therapy consisting of peg-IFN and RBV alone (current standard of care).
The thymalfasin treatment group did not achieve statistical significance for the primary endpoint of sustained virological response (SVR) as assessed in the primary analysis population, i.e., the intent-to-treat (ITT) population. In the prospectively defined secondary population of patients who completed the full course of 48 weeks of treatment with thymalfasin in addition to peg-IFN-2a and RBV (Completer Population), the primary endpoint achieved statistical significance.
‘We are disappointed that the study did not reach its primary efficacy endpoint in the ITT population. Nevertheless, the data seen in the Completer Population suggest a potential benefit of using thymalfasin in patients who completed the full course of treatment,’ said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. ‘We plan to analyze the data further in coming weeks and will present the full results at an upcoming clinical conference.’
In the ITT population (552 patients), 12.73% of the patients in the thymalfasin treated group achieved an SVR at week 72 of the trial, versus 10.47% in the control group (p=0.407). In the Completer Population (182 patients), the difference in SVR between the thymalfasin treated group and the control group achieved statistical significance (p=0.048).
‘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.’
Release Date: November 5, 2008
Source: SciClone Pharmaceuticals