Human Genome Sciences Announces Albuferon(R) Meets Primary Endpoint in Phase 3 Trial in Chronic H...(900-mcg albinterferon alfa-2b treatment ...)

Date:12/8/2008

900-mcg albinterferon alfa-2b treatment group to the peginterferon alfa-2a treatment group. The trial included 24 weeks of treatment, and the primary efficacy endpoint was non-inferiority to peginterferon alfa-2a, based on a comparison of the rate of SVR, defined as undetectable viral load (HCV RNA < 10 IU/mL) at Week 48 (24 weeks following completion of treatment).

"We are encouraged that albinterferon alfa-2b met the primary efficacy endpoint of non-inferiority to peginterferon alfa-2a in the ACHIEVE 2/3 study," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "These data show that the rate of sustained virologic response was comparable for the treatment group receiving the 900-mcg dose of albinterferon alfa-2b every two weeks, versus the treatment group receiving the standard dose of peginterferon alfa-2a once weekly. Importantly, the number of serious and severe adverse events, including pulmonary adverse events, was also comparable. When we have ACHIEVE 1 results in March, we will be in a position to assess the full therapeutic potential of albinterferon alfa-2b."

Key Findings from ACHIEVE 2/3

The topline ACHIEVE 2/3 results include the following key findings:

Treatment Group Receiving Albinterferon Alfa-2b 900-mcg Every Two Weeks, vs. Treatment Group Receiving Peginterferon Alfa-2a 180-mcg Every Week

• Based on an ITT analysis of the treatment group assigned to receive 900-mcg albinterferon alfa-2b every two weeks, the topline results demonstrate that albinterferon alfa-2b met its primary efficacy endpoint of non-inferiority to peginterferon alfa-2a, with 79.8% (249/312) of patients achieving SVR in the 900-mcg albinterferon alfa-2b treatment group, vs. 84.8% (263/310) in the peginterferon alfa-2a treatment group (p=0.0086 for non-inferiority).
• By region, SVR rates
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SOURCE Human Genome Sciences, Inc. Copyright©2008 PR Newswire. All rights reserved

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