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Study: Anidulafungin, Amphotericin B Combination Is Well-Tolerated With Few Drug-Related Adverse Events

KING OF PRUSSIA, Pa., March 24 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today announced results from a Phase III trial evaluating the company's lead product anidulafungin, a novel antifungal therapy, in combination with liposomal amphotericin B (LAmB) for the potential treatment of invasive aspergillosis infections. Aspergillosis is an opportunistic fungal infection acquired by patients with weakened immune systems and is frequently fatal.

"These results demonstrate that we can combine these two treatments to fight invasive aspergillosis infections without increasing side effects," said Raoul Herbrecht, MD, Department of Hematology and Oncology, Hopital de Hautepierre, Strasbourg, France, and lead investigator in the study. "Anidulafungin's distinct mechanism of action, broad-spectrum activity and novel route of elimination make it a particularly attractive therapy for use in combination antifungal treatments."

"In addition to providing important evidence that combining anidulafungin with an amphotericin agent is well-tolerated as first line therapy, these data confirm previous and other data that the pharmacokinetic profile of anidulafungin makes it well-suited for potential combination strategies to fight deadly invasive fungal diseases," said Timothy Henkel, M.D., Ph.D., Vicuron's Chief Medical Officer.

Previous in vitro studies have shown compelling results demonstrating anidulafungin's additive or synergistic effect in combination with a variety of other antifungal agents. Results from another study evaluating the concomitant use of anidulafungin and voriconazole, an increasingly important agent for the treatment of aspergillosis, will be presented at an international medical meeting later this year.

Study Details and Results
The non-comparative, multi-center, global trial enrolled 30 patients with probable or proven invasive aspergillosis. Study patients were administered both LAmB at 3-5 mg per kg daily and anidulafungin intravenously at 100 mg daily, with an initial loading dose of 200 mg of anidulafungin on day one. The 95 percent confidence interval of the global response rate ranged from 12 to 49 percent. The combination was well tolerated with few drug-related serious adverse events. Adverse event and laboratory values at the end of the study were consistent with those expected for a critically ill patient population with invasive aspergillosis.

About Anidulafungin
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

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