Anti-Infectives (Track)

DEVELOPMENT OF ANFOLEISH (3% AMPHOTERICIN B CREAM), A TOPICAL TREATMENT FOR CUTANEOUS LEISHMANIASIS

Ivan Do Sara M. Robledo

PECET, Medical research Institute, University of Antioquia, Medellin – Colombia

Abstract

Cutaneous leishmaniasis (CL) is a parasitic disease affectingmillions of people in the world. The few available drugs are systemic, highly toxic, costly, and their efficacy is decreasing. Therefore, new effective drugs are needed. Systemic Amphotericin B (AmB) has been used for the treatment of visceral leishmaniasis and less frequently for CL. In vitro and in vivo studies have shown that AmB is active against all species of Leishmania ever tested, and so far, there is no evidence of resistance development in affected populations. In order to provide an effective local treatment for CL without associated systemic toxicity, Anfoleish, a new formulation of 3% AmB, was developed. The oil in water formulation with 3% AmB is stable and safe. Cure rates for 2x/day or once/day for 15 day treatment were 87.5% and 62.5% for Anfoleish and 25% and 12.5% for placebo (respectively). The cure rate for pentavalent antimonial was 71.4% and no healing was seen in negative control group. No toxicity was observed in animals treated with Anfoleish. Systemic exposure is minimal, which corroborates for its safety. Furthermore, observational studies in 16 volunteers with CL caused by L. panamensis have shown that Anfoleish is safe, with very promising healing results.