SciClone reports encouraging results from Phase IIa hepatitis trial

The trial was designed to evaluate the effect of SCV-07 on hepatitis C viral load, as well as on other measures of immune response. SCV-07 demonstrated activity in some treated patients in the higher dosage groups, and the decrease in viral load in these patients was accompanied by an increase in an immunological biomarker which is usually correlated with response against hepatitis C virus (HCV). Additionally, SCV-07 was shown to be generally safe and well-tolerated with no dose limiting toxicities or serious adverse events reported.

This randomized, placebo-controlled trial enrolled 34 patients infected with the difficult to treat genotype 1 strain of HCV, who had previously responded to treatment with interferon alpha and ribavirin but subsequently relapsed. Patients were randomized into three cohorts of escalating doses, and received daily subcutaneous injections of SCV-07 or placebo.

After completing seven days of therapy, all patients were monitored for a further seven days and patients in the highest dosage group were monitored for 30 days following end of treatment.

The primary objective of the trial was to assess the antiviral effect of SCV-07 on hepatitis C viral load and the pharmacodynamic effect as assessed by various biomarkers. In chronically infected patients, without treatment, variations in the amount of circulating HCV typically do not vary by more than 0.3 log. In this trial, reductions of greater than 0.6 log were seen in more than 10% of treated patients.

Friedhelm Blobel, president and CEO of SciClone, said: “Based on the promising outcome of this trial, SciClone plans to investigate further SCV-07’s potential to prime the human immune system against HCV and plans to discuss with the FDA the initiation of a follow-up Phase IIb trial.”