Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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United Press International - October 24, 2006
The company said it would begin recruiting female volunteers into the University of California, San Francisco-based study, which is funded by the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Starpharma said it would begin recruiting patients within a month into a second study in Kisumu, Kenya.
The trials will assess the safety of VivaGel when applied vaginally twice daily for 14 days in healthy women. The studies will each enroll 30 volunteers ages 18 to 24.
The trials represent the first NIH-funded research of a microbicide for prevention of genital herpes and would be the first microbicide approved for this indication, Starpharma said.
"This trial represents a key milestone in the development of VivaGel, and has been supported by NIAID and our clinical collaborators in the U.S. and Kenya. Given the high prevalence of genital herpes in Europe and the United States, and concern about it, we also consider prevention of this disease to be a commercially very important indication for VivaGel," said Starpharma CEO Jackie Fairley. Approximately 50 million people in the United States have genital herpes, the company estimated.
VivaGel is also being studied in a trial in Melbourne, Australia, for the prevention of HIV, also with the support of NIAID.
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