Coley begins trial of Actilon in hepatitis

The phase II clinical trial is expected to enroll 90 adults with genotype 1 hepatitis C virus (HCV) who have failed previous therapy with the current standard of care. Participants will be randomly assigned to one of three parallel treatment arms, which will evaluate two dose levels of Actilon in combination with pegylated interferon alpha and ribavirin or pegylated interferon alpha plus ribavirin alone.

The phase II clinical 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. Coley expects preliminary data from this phase II study to be available in the second half of 2006.

“Based on its promising safety profile, novel dual mechanism of action, which stimulates both the innate and adaptive arms of the immune system, and preclinical and phase I clinical studies data, we believe Actilon may prove to be an important component of both current and future therapeutic regimens in the treatment of chronic HCV,” said Dr Robert Bratzler, president and CEO of Coley.

Preliminary results from a dose-escalation trial which evaluated Actilon’s safety when administered as a monotherapy to HCV patients demonstrated that Actilon is generally well tolerated over a wide dose range, and induces dose-dependent antiviral and immune responses consistent with the known pharmacologic mechanisms of this new class of immunomodulatory antiviral drug candidates.