VivaGel(R) Demonstrates Anti-HIV and Herpes Activity Following Human Administration
04 Août 2009 - 2:31PM
PR Newswire (US)
MELBOURNE, Australia, Aug. 4 /PRNewswire-FirstCall/ -- Starpharma
Holdings Limited (ASX:SPLASX:OTCQX:ASX: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 Ellie Papathanasiou Tel: +61 2 9237 2800
Starpharma http://www.starpharma.com/ Dr Jackie Fairley Chief
Executive Officer +61 3 8532 2704 Ben Rogers Company Secretary +61
3 8532 2702 DATASOURCE: Starpharma CONTACT: Media, Rebecca Wilson,
+61 3 9866 4722, mobile +61 417 382 391, , or Ellie Papathanasiou,
+61 2 9237 2800, , both of Buchan Consulting; or Dr Jackie Fairley,
Chief Executive Officer, +61 3 8532 2704, or Ben Rogers, Company
Secretary, +61 3 8532 2702, , both of Starpharma Web Site:
http://www.starpharma.com/
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