Starpharma Holdings Limited (ASX:SPL) Completes Patient Testing In Retention Of VivaGel Antiviral Activity Study

Main Category: Sexual Health / STDs
Also Included In: HIV / AIDS;  Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials
Article Date: 20 Mar 2009 - 0:00 PDT

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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)." 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.

About: Starpharma Holdings Limited

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of dendrimer nanotechnology for pharmaceutical, life-science and other applications. SPL is principally composed of two operating companies, Starpharma Pty Ltd in Melbourne, Australia and Dendritic Nanotechnologies, Inc in Michigan, USA. Products based on SPL's dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents.

The Company's lead pharmaceutical development product is VivaGel(R) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.

Source
Starpharma Holdings Limited

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