The trial specifically evaluated the effect of the drug combination in treatment of hepatitis C patients with early cirrhosis of the liver who failed prior therapy. Addition of Zadaxin failed to produce an improvement in sustained virologic response, the trial’s primary endpoint.
Zadaxin was generally well tolerated with no treatment-related toxicities or side effects. In December 2005, SciClone reported final results from its first US phase III HCV trial, which were consistent with these results and not statistically significant.
“Given these results, our Zadaxin development efforts will be focused on advanced-staged malignant melanoma in conjunction with our European development and marketing partner, Sigma-Tau,” commented Dr Ira Lawrence, president and CEO of SciClone.