Migenix has received a notice of authorization from Health Canada to begin a Phase II viral kinetics study of MX-3253 (celgosivir) in hepatitis C virus (HCV)-infected, treatment-naive patients. The study is designed to demonstrate improved antiviral activity when celgosivir is used in combination with peginterferon alfa-2b, with or without ribavirin, as compared to treatment with peginterferon alfa-2b and ribavirin. Enrollment in the study is expected to commence in June 2006 with results expected in late 2006 or early 2007.
In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha with or without ribavirin and has the potential to be included as part of a combination therapeutic approach to improve efficacy. Celgosivir is currently being evaluated in a Phase IIb study in HCV-positive (genotype 1) patients who were non-responders or partial responders to previous treatment with pegylated interferon-based therapy.