Starpharma's VivaGel clears FDA review; herpes-prevention trials to start soon

By Elaine Rigoli

Tampa, Fla., July 19 - Starpharma Holdings Ltd. announced that the Investigational New Drug application for the clinical development of SPL7013 gel (VivaGel) for prevention of genital herpes has successfully completed the mandatory review period within the Food and Drug Administration.

Completion of the IND review period clears the way for the first clinical trial under this new clinical indication for VivaGel - prevention of genital herpes.

The clinical trial is expected to start in the third quarter of 2006 following local ethics committee approvals.

The trial will be conducted at two sites - San Francisco and Kenya - with safety as the primary endpoint. Thirty women, aged 18 to 24 years old, will be enrolled at each site, for a total of 60 volunteers.

The company said this is the first microbicide clinical-development program specifically for prevention of genital herpes to be funded by the National Institutes of Health.

Starpharma also said this is the first IND submitted to the FDA for a microbicide with prevention of genital herpes as the indication.

Starpharma is a biotechnology company located in Melbourne, Australia.

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