Sexually transmitted diseases can be prevented by new gel
VivaGel is in development as a microbicide for the prevention of the sexually transmitted infections genital herpes and HIV/AIDS.
Two clinical trials of VivaGel™ are currently in progress - a safety trial in men being conducted in Melbourne, Australia, and an expanded female safety study conducted at two trial sites in San Francisco, USA and Kisumu, Kenya.
Both of these trials are proceeding as planned, with recruitment in the male study nearing completion, and activities at both female study sites progressing well.
The VivaGel™ clinical trials are funded by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. These trials are not affected by the decision to halt the CS trials.
Phase III trials of CS were being conducted under the sponsorship of two not-for-profit research groups, CONRAD, and Family Health International. It is understood that at the recommendation of their respective Data Safety Monitoring Boards both sponsors chose to discontinue their CS trials after findings suggested that CS might be contributing to an increased risk of HIV infection.
The CS trial closure is unfortunate for the millions exposed to the risk of HIV infection, and will be a great disappointment to the microbicide community in general.
However the company considers the impact for Starpharma's shareholders to be positive as this development is likely to result in one less potential entrant into the topical microbicide market.
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