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www.fdanews.com/articles/71151-idenix-reports-trial-data-for-valopicitabine-pegylated-interferon

Idenix Reports Trial Data for Valopicitabine, Pegylated Interferon

April 15, 2005

Idenix Pharmaceuticals has announced preliminary Phase IIa clinical trial data for valopicitabine (NM283) in treatment naive genotype 1 hepatitis C patients.

In this Phase IIa clinical trial, nine patients receiving the combination of valopicitabine and pegylated interferon have reached 24 weeks of treatment, and achieved a mean reduction in serum HCV RNA of more than 99 percent.

In January, Idenix reported 12-week data on 12 patients receiving valopicitabine plus pegylated interferon combination therapy. Of the 12 patients previously reported, nine patients have now reached 24 weeks of combination treatment and have experienced substantial additional antiviral response. In eight of the nine patients, levels of virus have decreased to below 600 IU/mL, which is the lower quantification limit of the Amplicor PCR assay, an assay typically used by physicians to monitor the effectiveness of hepatitis C treatment. Six of the nine patients achieved undetectable levels of virus utilizing the real-time TaqMan PCR assay, an assay with a high level of sensitivity, which has a detection limit of 10 IU/mL.