There is a substantial need for a safe, effective topical treatment for genital herpes simplex (HSV) disease. The proposed research aims to evaluate feasibility of continued development of docosanol as a topical treatment for recurrent genital herpes simplex infections. In order to achieve this objective, we have developed the following specific aims:
Aim 1 : Develop a new formulation optimized for application to genital areas.
Aim 2 : Establish efficacy of the new formulation in an animal model of genital herpes.
Aim 3 : Test selected formulation for safety and tolerability in toxicology studies that meet FDA requirements. Phase II will expand on the Phase I outcome which showed that formulations containing both docosanol and acyclovir provided maximal inhibition of HSV disease in a cutaneous guinea pig model when compared to formulations containing either docosanol or acyclovir alone. Upon successful completion of the aims and establishment of safety and efficacy in the nonclinical models, the applicant intends to initiate Phase 2 and 3 clinical studies of the efficacy of topical docosanol formulations in the treatment of recurrent episodes of genital herpes. If proven safe and effective, it would provide a new single agent treatment as well as allow concurrent use with acyclovir.
Topical treatment for recurrent genital herpes infections.
