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.
Posted August 2nd, 2009
