STARPHARMA SUBMITS IND FOR GENITAL HERPES PREVENTION GEL

Starpharma has announced that the investigational new drug (IND) application for the clinical development of SPL7013 gel, VivaGel, for prevention of genital herpes has successfully completed the mandatory review period within the FDA.

Completion of the IND review period clears the way for the first clinical trial under this new clinical indication for VivaGel: the prevention of genital herpes. The clinical trial is expected to begin in the third quarter of 2006 following local ethics committee approvals. The trial will be conducted in San Francisco and Kenya, with safety as the primary endpoint. Thirty women, ages 18 to 24, will be enrolled at each site.