Human Genome announces interim results of phase 2b, phase 2 studies of Albuferon in hepatitis C

By Lisa Kerner

New York, March 14 - Human Genome Sciences, Inc. said interim results of its phase 2b and phase 2 trials of Albuferon (albumin-interferon alpha 2b) demonstrate that the drug was safe, well tolerated and showed robust antiviral activity in treating hepatitis C, inflammation of the liver caused by the hepatitis C virus.

Albuferon is Human Genome's novel, long-acting form of interferon alpha 2b, according to a company news release.

The phase 2b trial compares Albuferon (in combination with ribavirin) to Pegasys with ribavirin in patients with chronic hepatitis C genotype 1, naive to interferon alpha-based treatment regimens.

A randomized, open-label, multi-center, active-controlled, dose-ranging study, the phase 2b trial is 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 been enrolled and randomized into four treatment groups.

The primary efficacy endpoint of the phase 2b study is sustained virologic response, defined as undetectable virus 24 weeks after completion of 48 weeks of treatment.

The phase 2 study of Albuferon in combination with ribavirin includes 115 patients with chronic hepatitis C who failed to respond to previous interferon alpha-based treatment regimens.

This randomized, open-label, multi-center dose-escalation study is being conducted in the United States with patients enrolled into five treatment groups.

The primary efficacy endpoint of the phase 2 study is sustained virologic response.

Human Genome said it will release full interim data on both studies on April 29 and April 30 at the European Association for the Study of the Liver.

"Assuming that positive data continue to emerge from this phase 2b study and our other ongoing phase 2 trials of Albuferon, we plan to meet with clinical experts and regulatory authorities to discuss the initiation of phase 3 development of Albuferon by year-end 2006," said David C. Stump, executive vice president, drug development, in the release.

Based in Rockville, Md., Human Genome discovers, develops, manufactures and markets innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.