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HGS initiates first trial in hepatitis C program

Human Genome Sciences has initiated dosing in one of two phase III trials of Albuferon in combination with ribavirin in treatment-naive patients with hepatitis C.

The Albuferon phase III development program includes two trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus peginterferon alfa-2a in combination with ribavirin.

“We believe that Albuferon could become the interferon of choice in treatment regimens for this potentially devastating disease,” said Thomas Watkins, president and CEO, HGS.

According to HGS, the current standard of care for hepatitis C patients, pegylated interferon alpha plus ribavirin, has side effects that continue to be a significant treatment-limiting issue. Albuferon requires half as many injections, and clinical results to date suggest the potential for less impairment of health-related quality of life, with efficacy and safety at least comparable to pegylated interferon.

“There continues to be a significant need for more effective and better tolerated treatments for chronic hepatitis C,” said John McHutchison, professor of Medicine and Director, GI/Hepatology Research, Duke Clinical Research Institute.

Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006. The company plans to make global marketing applications for Albuferon in 2009.