Singapore, May 12, 2008: Australian pharma company Starpharma Holdings Limited has announced positive results of a clinical trial that achieved all its objectives.
Starpharma said Vivagel was safe and well tolerated in sexually abstinent women when administered vaginally, twice daily for 14 days.
Based on these results and existing supporting data, the product is deemed suitable for continued development as a topical microbicide for the prevention of HIV and genital herpes (HSV) and the exploration of other potential indications. These findings support current and future clinical studies to assess the safety and efficacy of VivaGel for genital herpes and HIV in sexually active women.
The study enrolled 54 women in the US and Kenya and was double blinded so that the participants, the investigators and study staff did not know who was receiving VivaGel or placebo gel.
Starpharma’s CEO, Dr Jackie Fairley said, “We are pleased to report that VivaGel has met its safety and tolerability endpoints in this expanded safety study. We look forward to moving ahead with further trials of the product - both in the HIV and HSV-2 programs and also potentially in additional applications of VivaGel including other STIs and contraception.”
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