Data from the Phase II non-responder study were presented on April 15, 2007 at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL) held in Barcelona, Spain and on May 21, 2007 at Digestive Disease Week (DDW) 2007 held in Washington, DC.
On June 26, 2007, Schering-Plough advised us that they would not be entering into a second period of exclusivity to negotiate the terms of a license agreement for celgosivir at that time. MIGENIX is now in various stages of discussions with other interested parties for the partnering of celgosivir.
A Phase II viral kinetics combination study of celgosivir in patients with chronic HCV (genotype 1) infection who have not received prior treatment for their infection is ongoing. The focus of this study is on viral kinetics, pharmacokinetics, safety and tolerability of celgosivir in combination with peginterferon alfa-2b with ribavirin. As reported previously, enrollment in the study has been slower than anticipated. Interim 4-week data from the study are expected in approximately 10 patients in October 2007, with guidance for 12-week data to be provided in conjunction with the 4-week data.
All MIGENIX-related clinical trials of celgosivir to date have been conducted in Canada. An Investigational New Drug (IND) application is planned to be submitted to the US FDA in the first quarter of 2008 for the future development of celgosivir.
Omiganan (CLS001; topical cationic peptide; treatment of dermatological
diseases): Cutanea Life Sciences, Inc., our development and
commercialization partner for CLS001, is conducting a Phase II rosacea
clinical trial in the United States. The Phase II trial is a randomized,
vehicle-controlled, double-blind, multi-center study designed to evaluate
the safety and
|SOURCE MIGENIX Inc.|
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