Aug 3 2009
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced the results of its clinical trial demonstrating that VivaGel® retains antiviral activity against human immunodeficiency virus (HIV) and herpes simplex virus (HSV, the virus that causes genital herpes), following vaginal administration in women.
The clinical study was conducted to assess the antiviral activity of VivaGel® (SPL7013 Gel) in cervicovaginal fluid samples (CVS) taken from healthy women immediately, then at 1, 3, 12 and 24 hours after separate vaginal doses of the product. These samples were tested for their ability to prevent HIV and genital herpes (HSV-2) infection of susceptible cells in the laboratory.
The study showed that CVS obtained immediately after vaginal administration of VivaGel® provided effectively complete inhibition of HIV and HSV infection in vitro.
At 1 and 3 hours following administration of product, the initial high level of inhibition of HIV and HSV was retained in all women tested.
Even at 12 and 24 hours following administration, more than 90% of the initial antiviral activity was retained for both HIV and HSV in more than half of the women enrolled in the study.
This is the first clinical study to demonstrate potent antiviral activity of any microbicide beyond one hour after administration of the product in humans. These data indicate the potential for VivaGel® to be used other than immediately prior to sexual intercourse (i.e., as a coitally-dissociated microbicide). However, future testing in clinical efficacy studies is required to confirm this.
“These results are extremely encouraging,” said Dr Jackie Fairley, CEO of Starpharma. “They show not only an excellent level of activity, but also a sustainability of effect that exceeded our expectations. The retention of potent activity several hours after administration can only enhance the commercial prospects of VivaGel®,” Dr Fairley added.
There were no serious adverse events during the study, and as previously announced the data indicate VivaGel® was well-tolerated.
The study was conducted in Melbourne at the Centre for Clinical Studies and in collaboration with the Burnet Institute. The study was funded by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), under Contract No. HHSN266200500042C.*
About Starpharma
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 has two operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the USA. Products based on SPL’s dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents through licence arrangements with partners including Siemens and Merck KgA.
The Company’s lead pharmaceutical development product is VivaGel® (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes. In September 2008 Starpharma signed a full licence agreement with SSL International plc (LSE:SSL) to develop a VivaGel® coated condom. SSL manufactures and sells Durex® condoms, the market-leading condom brand worldwide. Starpharma's receipts under the agreement are estimated to exceed A$100m comprising royalties on SSL sales, further milestone payments, and development support.
In the wider pharmaceutical field Starpharma has specific programs in the areas of Drug Delivery and Drug Optimisation technologies (using dendrimers to control where and when drugs go when introduced to the body) and Targeted Diagnostics (using dendrimers as a scaffold to which both location-signalling and targeting groups are added to allow location of specific cell type, such as cancer cells). More broadly the company is exploring dendrimer opportunities in materials science applications including water remediation.
Dendrimer: A type of precisely-defined, branched nanoparticle. Dendrimers have applications in the medical, electronics, chemicals and materials industries.
American Depositary Receipts (ADRs): Starpharma’s ADRs trade under the code SPHRY (CUSIP number 855563102). Each Starpharma ADR is equivalent to 10 ordinary shares of Starpharma as traded on the Australian Securities Exchange (ASX). The Bank of New York Mellon is the depositary bank. Starpharma’s ADRs are listed on International OTCQX (www.otcqx.com), a premium market tier in the U.S. for international exchange-listed companies, operated by Pink OTC Markets, Inc.