VivaGel proposed single-use applicator
Melbourne, Mar 19, 2009 AEST (ABN Newswire) - Starpharma Holdings Limited (ASX:SPL)(PINK:SPHRY) today announced the completion of patient testing in a clinical trial of VivaGel(R) that explores the length of time the antiviral activity of VivaGel remains following application.
The study, in 12 healthy women, is designed to measure the level of antiviral activity retained by VivaGel(R) after vaginal administration, and therefore how long before sex VivaGel(R) could be applied to prevent infection. Vaginal samples have been collected from each study participant up to 24 hours after five separate VivaGel(R) applications, and these samples are now being analysed for anti-HIV and anti-HSV-2 (genital herpes) activity.
Preliminary findings indicate that the gel was well tolerated by the women. This is in line with results from three other completed studies - two in women and one in men - showing the gel to be safe and well tolerated.
"We consider this trial to be very valuable in providing a surrogate for the antiviral efficacy of VivaGel(R) in humans ahead of Phase 3 studies. The data collected in this trial builds upon the already strong package of information we have for VivaGel(R)," said Dr Jackie Fairley, Chief Executive Officer of Starpharma. "Last month we received good news of the partial effectiveness of another topical microbicide with a mode of activity similar to that of VivaGel(R).(R) Dr Fairley added.
Full trial results will be available following complete analysis of the laboratory samples and study data, expected within approximately two months.
The study was conducted at the Centre for Clinical Studies in Melbourne. Additional details of the study are included in Appendix 1 to this announcement.
Starpharma's VivaGel(R) is a topical microbicide in development for the prevention of HIV and HSV-2. Other applications of VivaGel(R) are also under assessment, including the prevention of human papillomavirus (HPV), contraception and the treatment of bacterial vaginosis.
Contact
Dr Jackie Fairley
Chief Executive Officer
TEL: +61-3-8532-2704
Ben Rogers
Company Secretary
TEL: +61-3-8532-2702
ben.rogers@starpharma.com
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