SciClone’s Phase III Hepatitis Trial Fails Endpoint
SciClone Pharmaceuticals, a biopharmaceutical company, and Italy-based pharmaceutical company Sigma-Tau have announced top-line results from a large, randomized, Phase III clinical trial evaluating thymalfasin in combination with pegylated interferon alpha-2a and ribavirin as a treatment for patients with hepatitis C virus who have not responded to prior therapy consisting of peg-IFN and RBV alone.
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, ie, 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 pegylated interferon alpha-2a (peg-IFN-2a) and ribavirin (completer population), the primary endpoint achieved statistical significance.
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).
Friedhelm Blobel, president and CEO of SciClone Pharmaceuticals, said: “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.”