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Starpharma Holdings Limited (ASX:SPL,USOTC:SPHRY) today signed an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD) of the US National Institutes of Health (NIH), to provide funding of a further clinical trial of VivaGel™ in sexually active women.
This further support from the NIH is non-dilutive for shareholders, and, like other NIH funding to date, has no negative impact on the commercial returns that Starpharma will receive from VivaGel™. This support is in addition to the previously announced US$20.3 million (A$26m) funding provided by the NIH to support the development of VivaGel™ for the prevention of HIV, and the funding of the clinical study related to VivaGel™ for the prevention of genital herpes.
"This is exciting news. The clinical study will complement the ongoing development activities being conducted under a range of NIH funded mechanisms for the development of VivaGel™ for prevention of HIV and genital herpes, and further consolidates the company's important relationship with the NIH," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.
The trial will be conducted by The Microbicide Trials Network (MTN), a worldwide collaborative clinical trials network established by Division of AIDS (DAIDS) of the NIAID to evaluate the safety and efficacy of microbicides. The trial will be sponsored by NIAID and NICHD, and co-sponsored by Starpharma.
The study will be conducted at two sites in the United States: University of South Florida, Tampa, Florida and University of Puerto Rico, San Juan, Puerto Rico. The study is expected to commence in the second quarter of 2007.
VivaGel™ is under development for the prevention of HIV and genital herpes.
About Starpharma Holdings Limited
Starpharma Holdings Limited (ASX:SPL, USOTC:SPHRY) is a world leader in the development of dendrimer nanotechnology for pharmaceutical, life-science and other applications. SPL is principally composed of two operating companies, Starpharma Pty Ltd in Melbourne, Australia and Dendritic Nanotechnologies, Inc in Michigan, USA. Products based on SPL’s dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents.
The Company’s lead pharmaceutical development product is VivaGel™ (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
In the pharmaceutical field Starpharma has additional specific programs in the areas of Drug Delivery and ADME Engineering™ (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).
More broadly the company is actively exploring dendrimer opportunities in materials science with applications as diverse as adhesives, lubricants and water remediation.
SPL has a comprehensive IP portfolio that comprises more than 180 patents/applications issued and pending across 32 patent families - a unique level of IP concentration among nanotechnology companies.
Dendrimers: A type of precisely-defined, branched nanoparticle. Dendrimers have applications in the medical, electronics, chemicals and materials industries.
Microbicides: A microbicide inactivates, kills or destroys microbes such as viruses and bacteria. Microbicides may be formulated as gels, creams, sponges, suppositories or films with the purpose of reducing significantly the incidence of STIs. They are intended for vaginal or rectal use to affordprotection for varying periods, from several hours up to days. Microbicides may also be designed to have a contraceptive function.
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.
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