Migenix gets Canadian OK for MX-3253 phase 2 viral kinetics study in hepatitis C virus

By Lisa Kerner

Erie, Pa., May 16 - Migenix Inc. said it received a Notice of Authorization from Health Canada to begin a phase 2 viral kinetics study of MX-3253 (celgosivir) in hepatitis C virus (HCV) infected treatment-naive patients.

The phase 2 study is designed to determine the efficacy, safety, tolerability and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b, with or without ribavirin in a 12 week-period.

The current standard of care for chronic hepatitis C is pegylated interferon combined with ribavirin.

Up to 30 patients will be randomized into three treatment arms: celgosivir plus peginterferon alfa-2b plus ribavirin (3-way combination); celgosivir plus peginterferon alfa-2b (2-way combination) and peginterferon alfa-2b plus ribavirin (control).

Migenix said enrollment is expected to begin in June, with results expected in late 2006 or early 2007.

MX-3253 (celgosivir), an alpha-glucosidase I inhibitor, is being evaluated in a phase 2b study in HCV-positive (genotype 1) patients who were non-responders or partial responders to previous treatment with pegylated interferon-based therapy. Results of this study are expected in October 2006.

"We are very pleased that Health Canada has authorized another clinical trial that includes both 2-way and 3-way combinations of celgosivir with peginterferon alfa-2b/ribavirin in HCV-infected patients," vice president of clinical development AnnKatrin Petersen said in the release.

"This 12-week viral kinetic trial in treatment-naive patients will put us in a good position to fully assess the synergistic treatment benefit of celgosivir in combination with peginterferon with or without ribavirin, and therefore provide a solid basis to move the compound forward into the next stage of development."

Migenix, based in Vancouver, B.C., develops and commercializes drugs for the treatment of infectious and degenerative diseases.

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