Clinical Trials Resource Center

New Medical Therapies™

Aspergillosis

October 15, 2007

Merck announced positive interim results from a phase II trial of Cancidas for the treatment of invasive fungal infections in pediatric subjects. This prospective, open-label, multi-center non-comparative study enrolled subjects aged three months to 17 years with invasive aspergillosis, esophageal candidiasis or invasive candidiasis. The subjects received Cancidas at 50 mg/m(2) daily (maximum 70 mg daily) following a 70 mg/m(2 )loading dose on day one. Patients could be dose-escalated to Cancidas 70 mg/m(2) daily (maximum 70 mg/day) if they were not responding. The duration of treatment was individualized for each subject, however the mean duration for those with invasive aspergillosis was 42.7 days, 12.3 days for invasive candidiasis and 32 days for esophageal candidiasis. Preliminary data from the first 39 treated subjects revealed that 74% of the subjects showed an improvement in the signs and symptoms related to the infection type studied. Specifically, 81% of subjects with invasive candidiasis, 100% of subjects with esophageal candidiasis and 50% of subjects with invasive aspergillosis had a positive response after the end of Cancidas therapy. Treatment was well tolerated, with no reported serious adverse events.

March 29, 2004

Vicuron Pharmaceuticals reported positive results from a phase III trial investigating anidulafungin, an antifungal in combination with liposomal amphotericin B (LAmB) for the treatment of invasive aspergillosis infections. Results showed that the global response rate ranged from 12 to 49% at the 95% confidence interval. The non-comparative, multi-center, global trial enrolled 30 subjects with invasive aspergillosis. Subjects 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. Treatment was well tolerated with few drug-related serious adverse events.

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