DUAL-listed Starpharma has wrapped up an expanded safety study of its vaginal gel in healthy sexually active women in the United States and Puerto Rico.

Dr Jackie Fairley, Starpharma CEO

Sixty-one women completed the Phase 2b study, using a vaginal gel twice a day for 14 days.

“We are pleased that these findings, like past expanded safety studies, are positive findings,” Starpharma chief executive officer Dr Jackie Fairley told BTN

The Australian Securities Exchange-listed company found Starpharma VivaGel was safe and well tolerated when used twice a day for 14 days in sexually active women.

VivaGel is a vaginal microbicide which aims to prevent the transmission of sexually transmitted infections including HIV and genital herpes.

It is designed to be “discreetly applied” before intercourse.

However, the women participating in the trial were asked to use a gel on a twice-a-day timetable, not before sex, Fairley said.

While this was a higher dose than usual, the women participating in the study used the gel as requested.

“Adherence by those participants was 95 to 100 per cent,” she said.

Twenty-two were dosed with 3.5 grams of Starpharma VivaGel (3% SPL7013) twice a day, while 21 received a matched placebo and 18 applied an experimental hydroxyethyl cellulose placebo.

All three groups were HIV negative.

During pelvic exams, investigators found results for the groups were comparable in terms of percentage of women with one or more abnormal genital findings related to the gels.

Fairley said the data supported VivaGel’s development as a standalone gel and a condom-coating product.

Secondary assessments of the Phase 2b study are expected to be completed in the June quarter, she told BTN

Further clinical studies of VivaGel, including a Phase 2 efficacy study of the gel in patients with the inflammatory condition bacterial vaginosis are due to begin this year.

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