Coley's Actilon for hepatitis therapy gets fast-track designation

By Elaine Rigoli

Tampa, Fla., May 17 - Coley Pharmaceutical Group, Inc. said the Food and Drug Administration has granted fast-track designation to Actilon for use in treatment-refractory patients chronically infected with the hepatitis C virus.

The fast-track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Actilon is an investigational toll-like receptor 9 agonist designed to induce both rapid and sustained immune responses that can have durable antiviral effects, according to a news release.

Positive data from the company's 12-week phase 1b clinical study of Actilon in combination with pegylated interferon and ribavirin among treatment-refractory patients, who had initially responded but then relapsed after treatment with pegylated interferon and ribavirin, were presented in April at the European Association for the Study of the Liver meeting in Vienna, Austria.

A 48-week phase 2 clinical study evaluating safety and activity of Actilon in combination with pegylated interferon and ribavirin is enrolling treatment-refractory hepatitis C virus patients who never responded after a minimum of 12 weeks of pegylated interferon and ribavirin treatment.

Coley is an international biopharmaceutical company with headquarters in Wellesley, Mass.

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