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Study Enrollment is Announced

August 13, 2005

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This is a drug being developed in Canada in cooperation with Schering Plough. Seeing as Schering is currently the number two provider of Hepatitis c therapy this new compound must have quite a bit of credibility.

Of course, Schering may only be interested in this as an adjunct to interferon therapy, not a replacement for.

Migenix to test hepatitis C drug

Migenix has received authorization from Health Canada to begin a phase IIb combination study of MX-3253, a compound in development for the treatment of chronic hepatitis C virus infections.

12 Aug 2005, 08:50 GMT - Enrollment in the study is expected to commence in the next few weeks with results expected around mid- year 2006.

MX-3253 (celgosivir) is an alpha-glucosidase I inhibitor and is currently the only oral anti- hepatitis C virus (HCV) drug in development that acts through host-directed glycosylation. In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha plus ribavirin suggesting it 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 (three-way combination); celgosivir plus peginterferon alfa-2b (two-way combination); and placebo plus peginterferon alfa-2b plus ribavirin (control).

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). 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.

"This is an important step in the development of celgosivir", stated Dr Jim DeMesa, 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."

Posted by Ralph at August 13, 2005 3:12 AM