This is the first microbicide clinical development program specifically for prevention of genital herpes to be funded by the US National Institutes of Health (NIH). Starpharma also understands that this is the first investigational new drug (IND) application to be submitted to the FDA for this indication.
Completion of the IND review period clears the way for the first clinical trial under this new clinical indication for VivaGel, which is also being developed for the prevention of HIV.
The clinical trial is expected to commence in the third quarter of 2006 following local ethics committee approvals. The trial will be conducted at two sites and enroll 60 women aged 18 to 24.