HCV
Celgosivir Cleared for Phase IIb Combination Study in HCV Non-responders
By MIGENIX Inc.
Aug 11, 2005, 23:19

MIGENIX Inc. , a clinical-stage developer of drugs for infectious and degenerative diseases, has received a Notice of Authorization from Health Canada for a clinical trial application (CTA) 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- year calendar 2006.

"This is an important step in the development of celgosivir", stated Jim DeMesa, MD, President and CEO of MIGENIX. "Our recent agreement with Schering- Plough, the strong preclinical synergy of celgosivir with interferon-alpha plus ribavirin, and the participation of many of the same investigators from our Phase IIa trial - combined with this regulatory approval - give us great encouragement for success in this Phase IIb trial".

About MX-3253 and the Phase IIb Combination Study

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 calendar 2005.

The Phase IIb combination study of MX-3253 is a randomized, multi-center, active-controlled, 12 week evaluation of MX-3253 in three treatment arms of up to 20 chronic HCV patients each: celgosivir plus peginterferon alfa-2b plus ribavirin (3-way combination); celgosivir plus peginterferon alfa-2b (2-way combination); and placebo plus peginterferon alfa-2b plus ribavirin (control). An agreement was completed in July with Schering-Plough for (a) the supply of PEGETRON(TM) (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) and (b) certain technical and laboratory support and other services for the study.

Patients for the Phase IIb study will be selected based on having genotype 1 chronic HCV and having failed to respond to pegylated alpha interferon plus ribavirin therapy (non-responders). Today, there are very limited treatment options for the 40% to 50% of hepatitis C patients who have failed treatment with the current standard of care, pegylated interferon plus ribavirin. Among this patient population, approximately 10% respond to retreatment with pegylated interferon plus ribavirin. Patients who respond to therapy during the Phase IIb trial will have the option to continue on treatment for up to 48 weeks. The study will measure viral load at various time points, as well as a number of safety parameters.

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