MEDIA RELEASE PR35589
VivaGel® Demonstrates Anti-HIV and Herpes Activity Following Human
Administration
MELBOURNE, Aug. 4 /Medianet International-AsiaNet/ --
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.*
* The following statement is included in accordance with the requirements of
Contract No. HHSN266200500042C:
The content of this announcement does not necessarily reflect the views or
policies of the Department of Health and Human Services, nor does mention of
trade names, commercial products, or organizations imply endorsement by the
U.S. Government.
For further information:
Media
Buchan Consulting
Rebecca Wilson
Tel: +61 3 9866 4722
Mob: +61 417 382 391
rwilson@bcg.com.au
Ellie Papathanasiou
Tel: +61 2 9237 2800
epapathanasiou@bcg.com.au
Starpharma
Dr Jackie Fairley
Chief Executive Officer
+61 3 8532 2704
Ben Rogers
Company Secretary
+61 3 8532 2702
ben.rogers@starpharma.com
SOURCE: Starpharma
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