VANCOUVER and SAN DIEGO, Dec. 13 /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 October 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 being conducted by our development and commercialization partner Cadence Pharmaceuticals 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. Cadence expects they will complete enrollment of the 1,850 patients planned for the trial in the second quarter of 2008, with results available in the second half of 2008. If the results of the CLIRS trial are positive, Cadence expects to submit a New Drug Application ("NDA") for omiganan 1% gel in the first half of 2009.
Celgosivir (MX-3253; oral alpha-glucosidase I inhibitor; treatment of chronic hepatitis C virus infections): Final top-line results of a Phase II 12-week combination therapy 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 alone) in patients with chronic hepatitis C virus genotype 1 infections who were characterized as non-responders to prior therapy with optimized pegylated alpha interferon plus ribavirin.
|SOURCE MIGENIX Inc.|
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