Human Genome Sciences Announces Initiation of Phase 2b Trial of Albuferon(R) Dosed Monthly in Chronic H...(ks had efficacy comparable to peginterfe...)

"Hepatitis C is the most common chronic blood-borne infection in the developed world, and there continues to be a significant need for more effective and better tolerated treatments," said Mani Subramanian, M.D., Ph.D., Executive Director, Clinical Research - Infectious Diseases, HGS. "Only an estimated 40% of U.S. patients diagnosed with chronic hepatitis C have undertaken treatment to date - in part due to the side effects associated with interferon injections, which are currently required on a weekly basis. A monthly dosing schedule with Albuferon may well result in more patients choosing to be treated."

About the Design of the Phase 2b Monthly Dosing Trial

This Phase 2b trial is a randomized, open-label, multi-center, active-controlled, adaptive-design dose-ranging study to evaluate the safety and efficacy of albinterferon alfa-2b administered every four weeks plus daily ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. Approximately 375 patients will be randomized in a 4:4:4:3 ratio into four treatment groups, including three that will receive albinterferon alfa-2b administered once every four weeks (900 mcg, 1200 mcg or 1500 mcg), in addition to the active-control group, which will receive peginterferon alfa-2a at the standard 180-mcg dose once every week. All patients in the study will receive 800-mg daily oral ribavirin. The total duration of treatment will be 24 weeks. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).

About Albinterferon Alfa-2b (Albuferon)

Albinterferon alfa-2b is a novel, longer-acting form of interferon alfa that was created using the proprietary HGS albumin-fusion technology
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