IND For Clinical Development Of VivaGel(TM) For Genital Herpes Prevention Clears US FDA

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.

Starpharma
http://www.starpharma.com