MELBOURNE, Oct. 24 /PRNewswire-FirstCall/ -- Starpharma Holdings Limited today announced that the U.S. site for the clinical trial of SPL7013 gel (VivaGel(TM)) for prevention of genital herpes has opened for recruitment of volunteers. This opening follows successful completion of all site preparation activities, and local ethics committee and regulatory reviews.
This trial is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The trial is the first specifically for a microbicide for prevention of genital herpes to be funded by the NIH.
On 19 July 2006, Starpharma announced that the Investigational New Drug (IND) application for the clinical development of VivaGel(TM) for prevention of genital herpes had successfully completed the mandatory review period within the U.S. Food and Drug Administration (FDA). Starpharma understands that this is the first clinical trial of a microbicide under an IND with prevention of genital herpes as the indication.
The U.S. clinical trial site, which opened for recruitment today, is at the University of California, San Francisco. The second site, in Kisumu, Kenya, is expected to be opened for recruitment within a month.
This clinical trial will examine the safety of VivaGel(TM) when applied vaginally twice daily for 14 days in healthy women. Thirty women aged 18-24 years will be enrolled in each site (total of 60 volunteers). The trial will provide key data to potentially enable VivaGel(TM) to progress into efficacy studies.
“We are very excited with the commencement of the first clinical trial of VivaGel(TM) under the prevention of herpes indication. This trial represents a key milestone in the development of VivaGel(TM), and has been supported by NIAID and our clinical collaborators in the U.S. and Kenya. Given the high prevalence of genital herpes in Europe and the U.S., and concern about it, we also consider prevention of this disease to be a commercially very important indication for VivaGel(TM),” said Dr Jackie Fairley, CEO of Starpharma.
VivaGel(TM) is being developed in parallel for the prevention of HIV, also with the support of NIAID, and another clinical trial of the product under a separate IND is ongoing in Melbourne, Australia.
Genital herpes is recognised as a key health concern in the U.S. where it is one of the most prevalent sexually transmitted diseases. It is estimated that genital herpes currently affects between 15% and 25% of adults in industrialised countries, with the incidence projected to rise drastically in the next decade. In the U.S. alone, approximately 50 million Americans already have genital herpes.
About Starpharma:
Starpharma Holdings Limited leads the world in the application of dendrimer-based nanotechnology to pharmaceuticals. The Company’s lead development product is VivaGel(TM) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
VivaGel(TM) is the first example of a product to come from Starpharma’s dendrimer-based discovery pipeline, which also includes specific programs in the fields of ADME Engineering(TM) (using dendrimers to control where and when drugs go when introduced to the body), Polyvalency (using the fact that dendrimers can activate multiple receptors simultaneously) and Targeted Diagnostics (using dendrimers as a scaffold to which both location-signalling and targeting groups are added to allow location of specific cell type, such as cancer cells).
Starpharma also has a wholly owned U.S. based operating subsidiary -- Dendritic Nanotechnologies, Inc. (DNT). DNT is committed to the innovation, development and commercialization of its proprietary Priostar(TM) dendrimer technology to create new commercial products with business partners. DNT was incorporated in 2003, is a U.S. company with 16 employees, and is located in Mount Pleasant, Michigan. DNT’s chief scientific officer, Donald A. Tomalia, Ph.D., is the inventor of dendrimers. DNT has a broad and comprehensive IP portfolio that comprises approximately 180 patents/applications issued and pending across 32 patent families -- a unique level of IP concentration among nanotechnology companies -- and has existing licensing agreements with established revenue streams for dendrimer technology. See http://www.dnanotech.com.
American Depositary Receipts (ADRs): Starpharma’s ADRs trade under the code SPHRY (CUSIP number 855563102). Each Starpharma ADR is equivalent to 10 ordinary shares of Starpharma as traded on the Australian Stock Exchange. The Bank of New York is the depositary bank.
For further information: Media Rebecca Wilson Buchan Consulting Tel: +61-2-9237-2800 Mob: +61-417-382-391 rwilson@bcg.com.au Starpharma Dr Jackie Fairley Chief Executive Officer Tel: +61-3-8532 2704 Ben Rogers Company Secretary Tel: +61-3-8532-2702 ben.rogers@starpharma.com
Starpharma
CONTACT: Media - Rebecca Wilson of Buchan Consulting, +61-2-9237-2800,Mob: +61-417-382-391, rwilson@bcg.com.au; or Starpharma - Dr JackieFairley, Chief Executive Officer, +61-3-8532-2704; or Ben Rogers, CompanySecretary, +61-3-8532-2702, ben.rogers@starpharma.com
Web site: http://www.starpharma.com/
