VANCOUVER, and SAN DIEGO, Sept. 11 /PRNewswire-FirstCall/ - MIGENIX Inc. (TSX: MGI; OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, reports financial results for the three months ended July 31, 2007 and an update on its programs.
UPDATE ON DRUG DEVELOPMENT PROGRAMS
Omiganan 1% gel (Omigard(TM)/CPI-226/MX-226; topical cationic peptide; prevention of catheter-related infections): A pivotal Phase III study is in progress in the United States under a Special Protocol Assessment (SPA) agreement with the US FDA and in Europe. This confirmatory Phase III trial is a randomized, Evaluation Committee-blinded study to assess the effectiveness of Omigard(TM) vs. 10% povidone-iodine for the prevention of central venous catheter-related infections. This ongoing trial is known as the Central Line Infection Reduction Study, or CLIRS trial.
On July 30, 2007 Cadence Pharmaceuticals, our North American and European development and commercialization partner for Omigard(TM), announced that the FDA had agreed with their plan to increase the number of patients to be enrolled in CLIRS trial from 1,250 to 1,850. Cadence also announced that in June 2007 it completed enrollment of the original target of 1,250 patients in this clinical trial. Cadence expects they will complete enrollment of the new goal of 1,850 patients in the second quarter of 2008. If the results of the CLIRS trial are positive, Cadence expects to submit an NDA for omiganan 1% gel in the first half of 2009.
Celgosivir (MX-3253; oral a-glucosidase I inhibitor; treatment of
chronic hepatitis C virus infections): Final top-line results of a Phase II
combination study in non-responder and partial responder patients were
announced April 11, 2007, demonstrating proof-of-concept and evidence of
clinical benefit when adding celgosivir to the current standard-of-care HCV
therapy (pegylated interferon plus ribavirin) as compared to the active
control treatment (standard-of-care
|SOURCE MIGENIX Inc.|
Copyright©2007 PR Newswire.
All rights reserved