FDAnews
www.fdanews.com/articles/71238-human-genome-sciences-reports-positive-results-of-albuferon-trial

Human Genome Sciences Reports Positive Results of Albuferon Trial

April 18, 2005

Human Genome Sciences has announced the results of a Phase II clinical trial of Albuferon in patients with chronic hepatitis C who are naive to interferon-alpha treatments.

The results demonstrated that Albuferon (albumin-interferon alpha) was well-tolerated, had a prolonged half-life and showed robust antiviral activity, with durable dose-dependent reductions in hepatitis C viral load. The Phase II trial, which was conducted in Canada, was a randomized, open-label, multicenter, parallel-design, dose-ranging study to evaluate the safety, tolerability, pharmacology and optimal dosing of Albuferon.

A total of 56 patients were enrolled in the trial and randomized to five dose groups (200 mcg, 450 mcg, 670 mcg, 900 mcg and 1200 mcg). Patients were given two doses of Albuferon monotherapy administered subcutaneously 14 days apart and were followed for safety and antiviral evaluations for a total of six weeks.