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Human Genome Sciences Announces Positive Final Results Of Phase 2b,Trial of Albuferon

vents was 9.3% in the Albuferon 900 Q2w treatment group, vs. 6.1% in the Pegasys group.

"The 900-mcg Albuferon dose has the potential to offer patients an attractive therapeutic option, requiring half as many injections as Pegasys, with more favorable quality of life effects and favorable sustained virologic response data," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS.

    Albuferon 1200-mcg Every Two Weeks (Albuferon 1200 Q2w)


    -- ITT analysis shows that 55.5% of patients in the Albuferon 1200 Q2w

       treatment group achieved SVR, vs. 57.9% for Pegasys administered every

       week.

    -- In heavier patients (>75 kg) who were treatment-adherent, 67.9% of

       those in the Albuferon 1200 Q2w treatment group achieved SVR, versus

       53.3% for Pegasys every week.

    -- Among all treatment-adherent patients in the Albuferon 1200 Q2w

       treatment group, 70.6% achieved SVR, versus 66.7% for Pegasys.

    -- ITT analysis shows that the Albuferon 1200 Q2w treatment group

       exhibited a robust early antiviral response (reduction in hepatitis C

       RNA viral load to below the level of quantitation):  74.5% for

       Albuferon 1200 Q2w at Week 12, vs. 65.8% for Pegasys.  The Albuferon

       1200 Q2w treatment group also had the most rapid time to HCV RNA

       negativity.

    -- The rate of discontinuations due to adverse events was 18.2% in the

       Albuferon 1200 Q2w treatment group, vs. 6.1% in the Pegasys group.

       Adverse events observed were those typically expected with interferon

       therapy.  Dose reductions were attempted in only 30.0% of Albuferon

       subjects prior to discontinuation, versus 42.9% for Pegasys.

"In the Albuferon Phase 3 trials, we will strongly encourage titration of dose where necessary to ensure tolerability, reduce the rate of discontinuations, and maximize the therapeutic benefit of the robust early antiviral
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