"The final Phase 2b results suggest that the every-two-week dosing regimen of Albuferon halves the number of injections that are required with peginterferon alfa-2a, while providing at least comparable efficacy, comparable safety and the potential for less impairment of quality of life and daily activity," said Stefan Zeuzem, M.D., Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany. "We are continuing the evaluation of the 900-mcg and 1200-mcg doses of Albuferon in larger populations in Phase 3 trials. We also conclude that monthly dosing of Albuferon deserves further evaluation."
In the open-label, multi-center, active-controlled Phase 2b trial, 458 treatment-naive patients with genotype 1 chronic hepatitis C were randomized to four treatment groups: Albuferon 900 mcg every two weeks, Albuferon 1200 mcg every two weeks, Albuferon 1200 mcg every four weeks, and peginterferon alfa-2a 180 mcg once a week. All patients received weight-based oral ribavirin daily. The trial included 48 weeks of treatment, and the primary efficacy endpoint was SVR, defined as undetectable viral load (HCV RNA<10 IU/mL) at 24 weeks following completion of treatment.
"Assuming that the Phase 2 results are confirmed in Phase 3, we believe that Albuferon could become the interferon of choice in combination regimens for the treatment of chronic hepatitis C," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "Both of our Phase 3 trials have completed enrollment ahead of schedule, and we expect to have Phase 3 data available by spring 2009 to support the filing of global marketing authorization applications by fall 2009."
Key Findings from the Phase 2b Study
Albuferon requires half the number of injections as peginterferon
alfa-2a, and the final results of the Phase 2b study demonstrated that
|SOURCE Human Genome Sciences, Inc.|
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