MIGENIX GETS APPROVAL TO START PHASE IIB HCV TRIAL

Migenex has received a Notice of Authorization from Health Canada for a clinical trial application to begin a Phase IIb combination study of MX-3253 (celgosivir), a compound in development for the treatment of chronic hepatitis C virus (HCV) infections. Enrollment in the study is expected to commence in the next few weeks with results expected around mid-2006.

MX-3253 (celgosivir) is an alpha-glucosidase I inhibitor and is currently the only oral anti-HCV drug in development that acts through host-directed glycosylation. In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha plus 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 IIa monotherapy study in treatment-naive and interferon-intolerant genotype I HCV patients with results of the study expected before the end of the third quarter of 2005. The Phase IIb combination study of MX-3253 is a randomized, multicenter, active-controlled, 12 week evaluation of MX-3253 in three treatment arms of up to 20 chronic HCV patients.