Starpharma
Holdings Limited (ASX: SPL; OTC: SPHRY) today announced that the
Investigational New Drug application (IND) for the clinical development of
SPL7013 gel (VivaGel(TM)) for prevention of genital herpes has successfully
completed the mandatory review period within the US Food and Drug
Administration (FDA).
This is the first microbicide clinical development program specifically
for prevention of genital herpes to be funded by the US National Institutes
of Health (NIH). Starpharma also understands that this is the first IND
submitted to the FDA for a microbicide with prevention of genital herpes as
the indication.
Starpharma announced lodgement of the IND on 26 June, 2006. Completion
of the IND review period clears the way for the first clinical trial under
this new clinical indication for VivaGel(TM) -- prevention of genital
herpes. The clinical trial is expected to commence in the third quarter of
2006 following local ethics committee approvals. The trial will be
conducted at two sites -- San Francisco (USA) and Kenya with safety as the
primary endpoint. Thirty women, aged 18-24 years, will be enrolled at each
site (total of 60 volunteers).
The IND was submitted by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the NIH, under the agreement executed
between Starpharma and NIAID, which was announced by the company in April
2006. VivaGel(TM) is being developed in parallel for the prevention of HIV,
also with the support of NIAID.
"Starpharma is very excited to be working with the NIH on this
microbicide development program, and with being the first to receive their
funding support for a microbicide for prevention of genital herpes," said
Dr Jackie Fairley, CEO of Starpharma.
Genital herpes is recognised as a key health concern, especially in the
US where it is one of the most prevalent sexually transmitted diseases. It
is estimated that genital herpes currently infects between 15% and 25% of
adults in industrialised countries, with the incidence projected to rise in
the next decade. In the US alone, approximately 45 million American
adolescents and adults are already infected with genital herpes.
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