Human Genome releases positive trial results for Albuferon, plans to seek higher-dose regimen

By Elaine Rigoli

Tampa, Fla., May 1 - Human Genome Sciences, Inc. said interim phase 2 study results evaluating Albuferon (albumin-interferon alpha 2b) in combination with ribavirin in patients with chronic hepatitis C (HCV) who failed to respond to previous interferon alpha-based treatment regimens demonstrated that Albuferon in combination with ribavirin was safe, well tolerated and showed robust and durable antiviral activity.

"One of the most important areas of medical need in the treatment of chronic hepatitis C is those patients infected with genotype 1 hepatitis C who have failed previous treatment with the standard-of-care combination of pegylated interferon and ribavirin. In this most difficult to treat subgroup, 63% of the patients receiving 1,800-mcg doses of Albuferon once every two weeks achieved early virologic response at week 12. At week 24, no detectable HCV RNA viral load was observed in 32% of the genotype 1 non-responders to standard-of-care in the 1,800-mcg treatment group," David C. Stump, executive vice president, drug development, said in a statement.

"Across the total patient population, the safety data from both of the higher-dose treatment groups was generally similar to safety data from the lower-dose treatment groups, but with greater antiviral activity. These results encourage us to evaluate a regimen in interferon-naive patients that combines higher doses of Albuferon with ribavirin administered at intervals of 28 days," he added.

The company released similar 12-week interim phase 2b trial results demonstrating that Albuferon with ribavirin was safe, well tolerated and showed robust antiviral activity.

The company said this data also supports continuing clinical evaluation of higher-dose Albuferon with monthly administration.

"These data warrant exploring the Albuferon 900-mcg and 1,200-mcg doses at two-week intervals in phase 3 clinical studies," said Stefan Zeuzem, a professor at Saarland University and a study clinical investigator, in a statement.

The company said it plans to meet with regulatory authorities in the coming months to discuss phase 3 development of Albuferon, with the intent to start a phase 3 trial by year-end 2006.

Rockville, Md.-based Human Genome develops 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.