Starpharma Holdings
Limited (ASX:SPL, OTC: SPHRY) will today present results of a clinical
trial indicating that 3% SPL7013 Gel (VivaGel(TM)) was well-tolerated in
men, and suitable for further development as a topical microbicide for the
prevention of HIV and genital herpes.
The results are to be presented by Starpharma in Sydney today at the
4th International AIDS Society (IAS) Conference on HIV Pathogenesis,
Treatment and Prevention, at which the research and development of
microbicides is a key focus.
The study compared 36 circumcised and uncircumcised men who applied
VivaGel(TM) (24 men) or a placebo gel (12 men) topically to their penis
once daily for seven days. The trial was double blinded so that the
participants, principal investigator and study staff did not know who was
receiving placebo or VivaGel(TM).
Overall, this study demonstrated that VivaGel(TM) was safe and well
tolerated, and comparable with placebo when applied to the penis of both
circumcised and uncircumcised healthy male volunteers once daily for seven
days, and left in place for approximately 9 hours. As seen in a previous
completed clinical trial in women, there was no evidence of absorption of
the active ingredient of VivaGel(TM), SPL7013, into the blood after topical
application.
The most commonly reported genital adverse events in both treatment
groups were considered to be mild and to be consistent with application to
the surface of the penis of a substance which dries and is not washed off
for a number of hours.
Acceptability was a secondary endpoint in this study and interviews
indicated that VivaGel(TM) would be acceptable to participants if shown to
be protective against sexually transmitted infections, and there were few
concerns around the potential impact on sexual pleasure.
A link to detailed results of the study is in the Appendix to this
announcement.
The clinical study was conducted at the Melbourne Sexual Health Centre,
in collaboration with the Burnet Institute and the National Centre in HIV
Epidemiology and Clinical Research, and was funded with U.S. Federal funds
from the National Institute of Allergy and Infectious Diseases, National
Institutes of Health (NIH), Department of Health and Human Services
(Contract No. HHSN266200500042C).
VivaGel(TM) is being developed as a topical vaginal microbicide for the
prevention of HIV and genital herpes, and is currently under investigation
in healthy female volunteers in two separate expanded safety clinical
trials at four sites in the U.S. and Kenya. VivaGel(TM) also shows promise
as a contraceptive agent.
VivaGel(TM) is also being explored as a condom coating following the
recent signing of an agreement with a leading international condom company.
The agreement includes a program of evaluation and development and also
commercialisation rights covering condoms with VivaGel(TM) coatings within
a specified geographical region. The condom company, whose name may not be
disclosed for reasons of confidentiality, holds the leading market position
within that region. The market in question is in the developed world, and
ranks within the top five globally, measured by GDP.
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 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(TM)
(SPL7013 Gel), a vaginal microbicide designed to prevent the transmission
of STIs, including HIV and genital herpes.
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 Stock
Exchange. The Bank of New York is the depositary bank.
Starpharma
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