COLEY INITIATES CLINICAL STUDY OF ACTILON FOR HEPATITIS C

Coley Pharmaceutical Group has announced the initiation of a randomized Phase II clinical study of Actilon (CPG 10101) for the treatment of patients with chronic hepatitis C infection.

The Phase II clinical trial is expected to enroll ninety adults with genotype 1 hepatitis C virus (HCV) who have failed previous therapy with the current standard of care. Subjects will be randomly assigned to one of three parallel treatment arms, which will evaluate two dose levels of Actilon (0.2 mg/kg once weekly or 0.5 mg/kg once weekly) in combination with pegylated interferon alpha and ribavirin or pegylated interferon alpha plus ribavirin alone (the current standard of care). The trial is designed to compare the safety and tolerability of the different drug combinations, as well as the efficacy of the regimens in reducing viral load over 12 weeks and achieving a sustained virologic response for 24 weeks following 48 weeks of treatment.