Systemic 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.

October 20, 2003

Schering-Plough reported positive results from a case series investigating Noxafil (posaconazole oral suspension), an antifungal agent for the treatment of coccidioidomycosis. Results showed that all subjects initially received benefit from the drug, and five were long-term successes during the follow-up period. Data showed that Noxafil produced rapid and significant clinical improvements, often with initial responses within one month. Noxafil appeared to be well tolerated and most reported adverse events were mild to moderate. The multicenter study enrolled six subjects and was designed to test the efficacy and safety of Noxafil, after standard antifungal therapies have failed. Results were presented at the 41st annual meeting of the Infectious Diseases Society of America in San Diego.

September 29, 2003

Schering-Plough reported positive results from 20 separate trials with Noxafil (posaconazole suspension), an oral anti-fungal agent for the treatment of life-threatening fungal infections. Results from two open-label phase III studies demonstrated that 71% of subjects (17 of 24) with zygomycosis achieved successful clinical outcomes when given salvage therapy with Noxafil. Results from a dose-ranging pharmacokinetic study enrolling 98 subjects showed successful clinical outcomes in 77% of subjects with febrile neutropenia and 43 % of subjects with invasive fungal infections refractory to standard therapy. Data showed that optimal exposure was attained when Noxafil 800 mg/d was given as a 200 mg dose four times daily, followed by a 400 mg dose twice daily as treatment progressed. Results were presented September 2003 at the 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

January 13, 2003

Versicor reported positive results from a phase II trial investigating anidulafungin for the treatment of invasive candidiasis and candidemia. Data showed that 88 % (23/26) of subjects exhibited a global response rate with a loading dose of 200 mg followed by a 100 mg maintenance dose per day. Results also showed that 89 % (25/28) of subjects exhibited a response rate with an analogous anidulafungin regimen of 150 mg followed by 75 mg per day, and 81 % (21/26) of subjects with 100 mg followed by 50 mg. These rates compare favorably with rates reported in previous clinical trials with other agents, such as fluconazole, amphotericin B and caspofungin, which range from 56 % to 81 % in subjects with invasive candidiasis/candidemia. The drug was well tolerated and adverse events attributable to the treatment were infrequent and similar for each dose. The randomized, open-label trial enrolled approximately 120 subjects in the U.S. with invasive candidiasis/candidemia.