HUMAN GENOME SCIENCES COMPLETES ENROLLMENT IN TRIAL OF ALBUFERON

Human Genome Sciences has completed enrollment, randomization and initial dosing in a Phase IIb clinical trial of Albuferon (albumin-interferon alpha) in combination with ribavirin in patients with chronic hepatitis C virus Genotype 1 who are naive to interferon alpha-based treatment regimens. Genotype 1 accounts for nearly 70 percent of all HCV infections in North America, and is generally regarded as the most difficult HCV genotype to treat.

The trial is a randomized, open-label, multicenter, active-controlled, dose-ranging study, being conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania. A total of 458 patients with chronic hepatitis C Genotype 1 have received initial treatment in the study. Patients have been randomized into four treatment groups, three of which receive subcutaneously administered Albuferon. The fourth treatment group serves as the active control group and receives weekly 180-mcg doses of subcutaneously administered Pegasys (peginterferon alfa-2a).

All patients receive weight-based oral daily ribavirin at 1000 or 1200 mg in two divided doses. The primary objective of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon alpha-naive patients with chronic hepatitis C Genotype 1. The primary efficacy endpoint is sustained virologic response, defined as undetectable virus at 24 weeks after completion of 48 weeks of treatment.