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Positive early data for Coley hepatitis drug

Coley Pharmaceutical has revealed positive top-line interim data from its twelve-week clinical study of its hepatitis C drug candidate Actilon in combination with pegylated interferon and/or ribavirin.

The aim of the study, in the relapsed subset of treatment experienced hepatitis C (HCV) patients, is to determine the tolerability and antiviral activity of various Actilon containing regimens relative to pegylated interferon and ribavirin.

Preliminary data from the study indicate that 86% of patients 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), compared to 57% of patients who received a control combination of pegylated interferon and ribavirin.

At twelve weeks, the Actilon combination therapy resulted in a 3.3 mean log reduction in HCV RNA level, compared to a 2.2 mean log reduction among patients receiving the control combination. The Actilon combination was well tolerated, and the kinds of adverse events observed were similar to those seen with the control combination, the company said.