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KING OF PRUSSIA, PA The Associated Press February 3, 2005 Biopharmaceutical company Vicuron Pharmaceuticals Inc. reported Monday that its fungus treatment anidulafungin was superior to standard-of-care treatment fluconazole for invasive candidiasis and candidemia in a late-stage clinical trial. Vicuron shares rose $1.71, or 11 percent, to $17.24 in midday trading on the Nasdaq. Results from the Phase III clinical trial, meant to show non-inferiority, showed that 75.6 percent of candidiasis and candidemia patients treated with anidulafungin had a successful global response to the treatment compared with the 60.2 percent response in patients treated with fluconazole. Fluconazole is the active ingredient in Pfizer Inc.'s antifungal treatment Diflucan. Invasive candidiasis and candidemia are the most common hospital-acquired fungal infections, the company said. Anidulafungin is made through a chemical modification of a naturally occurring molecule that has been shown to be highly potent against various fungi. Additionally, the trial showed that anidulafungin either matched or performed better than fluconazole in all secondary endpoints of the trial including responses at two weeks and six weeks after completing therapy. The company said it will file a new drug application for the treatment with the Food and Drug Administration in the third quarter and also file an amendment to its application for the drug to treat esophageal candidiasis in the second quarter. Copyright 2005 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. |
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