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Enrollment Complete for Anidulafungin Trial, Treatment for Invasive Candidiasis/Candidemia
KING OF PRUSSIA, Pa., Sept. 9 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today announced that the company has completed enrollment in its Phase III clinical trial of anidulafungin for invasive candidiasis/candidemia.
"We are pleased to have completed enrollment ahead of schedule," said George F. Horner III, President and Chief Executive Officer of Vicuron. "With a growing number of immunocompromised patients in the hospital, particularly those with cancer, the incidence of life-threatening, invasive fungal disease is rising. We look forward to releasing the results of this study in the first quarter of next year."
The double-blind, randomized Phase III trial of more than 250 patients was designed to study the safety and efficacy of a 100 mg daily dose of anidulafungin preceded by an initial 200 mg loading dose of anidulafungin versus fluconazole in invasive candidiasis/candidemia. Patients received daily intravenous (IV) infusions of either anidulafungin or fluconazole for 10 to 42 days. The primary endpoint is global assessment of clinical and microbiological responses at the end of IV therapy.
Anidulafungin is a naturally occurring molecule that has been significantly improved through chemical modification. In vitro studies have demonstrated that anidulafungin combines both the potency and killing effects of the polyene class (e.g. amphotericin B) without the resistance problems found with the azole class (e.g., fluconazole). Anidulafungin is a broad-spectrum agent, and has been demonstrated to be highly potent in vitro against the fungi responsible for several serious fungal infections. Preclinical studies have shown that five-minute exposure to anidulafungin in vitro kills more than 99 percent of Candida, including fluconazole-resistant strains. Anidulafungin has no cross-resistance with azoles or amphotericin, and in the laboratory it has proven very difficult to develop resistance to anidulafungin. Anidulafungin also was well tolerated in a Phase I study when given in combination with cyclosporine, the leading chronic immunosuppressive drug.
Source: Vicuron Pharmaceuticals Inc.