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Published on 3/21/2006 in the Prospect News Biotech Daily.

Coley releases 'positive' top-line data from clinical study of Actilon for hepatitis C

By Lisa Kerner

Erie, Pa., March 21 - Coley Pharmaceutical Group, Inc. announced what it termed as "positive" top-line interim data from its 12-week, randomized, controlled clinical study of Actilon (CPG 10101) in combination with pegylated interferon and/or ribavirin for the treatment of chronic hepatitis C virus (HCV).

The goal of the study is to determine the tolerability and antiviral activity of various Actilon-containing regimens relative to pegylated interferon and ribavirin, according to a company news release.

The study enrolled a total of 74 genotype 1 hepatitis C patients who were relapsed responders to pegylated interferon and ribavirin.

Patients were randomly assigned to one of five groups, receiving 12 weekly doses of Actilon alone and in combination with pegylated interferon and/or ribavirin.

Preliminary data indicate 12 out of 14 patients (86%) receiving a combination of Actilon with pegylated interferon and ribavirin achieved an Early Viral Response (greater than 2 log reduction in serum HCV RNA at 12 weeks).

This compared to eight out of 14 patients (57%) who received a control combination of pegylated interferon and ribavirin.

The Actilon combination was well tolerated, and adverse events observed were similar to those in the control combination.

Coley will present additional analysis at the European Association for the Study of the Liver meeting in Vienna, Austria, on April 29.

Coley is an international biopharmaceutical company based in Wellesley, Mass., that discovers and develops TLR Therapeutics that direct the human immune system to fight cancers, infectious diseases, asthma and allergy.


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