Oral Candidiasis

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.

May 14, 2007

Pacgen reported positive results from a phase I/II trial of PAC-113 for the treatment of oral Candida infections. This randomized, examiner-blinded, parallel design trial enrolled over 100 seropositive subjects in the US and South Africa. Subjects received PAC-113 mouth rinse and Nystatin oral suspension for 14 days. They were then evaluated during a 14-day follow-up period and a day 28 follow-up visit. Data outcomes were collected on the subjects who were at least 80% compliant to treatment. Results revealed that 37% of the PAC-113 subjects were assessed as clinically cured at day 14 compared to 36% of the Nystatin subjects. Complete or partial responses at day 14 were observed in 95% of those in the PAC-113 arm and 87% of the Nystatin arm. Treatment with PAC-113 was generally safe and well-tolerated. Based on the results Pacgen plans to initiate a phase IIb trial shortly.

March 31, 2003

Versicor reported positive results from a phase III trial investigating anidulafungin, an anti-fungal agent for the treatment of esophageal candidiasis. Results showed that the drug was as effective as fluconazole, the current standard-of-care medication. The primary efficacy endpoint, endoscopic success at the end of therapy, was determined to be 97.2 % (242/249 subjects) with anidulafungin and 98.8 % (252/255) with fluconazole. In addition, anidulafungin was well tolerated, with an adverse event and laboratory safety profile comparable to fluconazole. The randomized, double blind, double-dummy study was designed to investigate the safety and efficacy of intravenous anidulafungin versus oral fluconazole in 600 subjects with esophageal candidiasis.