MELBOURNE, Australia, Aug. 4 /PRNewswire-FirstCall/ -- Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) today announced the results of its clinical trial demonstrating that VivaGel(R) 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(R) (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(R) 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(R) 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(R)," Dr Fairley added.
There were no serious adverse events during the study, and as previously announced the data indicate VivaGel(R) 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 firstname.lastname@example.org Ellie Papathanasiou Tel: +61 2 9237 2800 email@example.com Starpharma www.starpharma.com Dr Jackie Fairley Chief Executive Officer +61 3 8532 2704 Ben Rogers Company Secretary +61 3 8532 2702 firstname.lastname@example.org
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