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U.S. NIH Funded Trial of VivaGel in Sexually Active Young Women Commences
  Melbourne, 10 July, 2007: Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced the commencement in the U.S. of a trial to assess the safety and acceptability of SPL7013 Gel (VivaGel) in sexually active young women.
The Microbicide Trials Network (MTN) is leading the study, funded by the U.S. National Institutes of Health (NIH), in which VivaGel will be tested for the first time in sexually active young women to determine its safety, acceptability and ease of use. VivaGel is being developed as a vaginal microbicide for the prevention of HIV and genital herpes.
The expanded safety study is being conducted at the University of South Florida in Tampa, Florida, and the University of Puerto Rico in San Juan, Puerto Rico, through a collaboration between the MTN (an HIV/AIDS clinical trials network established by the National Institute of Allergy and Infectious Diseases, NIH), the Adolescent Medicine Trials Network for HIV/AIDS Interventions (of the National Institute of Child Health and Human Development, NIH), and Starpharma.
Nearly 50 percent of people infected with HIV/AIDS today are women and most of them become infected through sexual intercourse with male partners. Women under the age of 25 are particularly at risk of infection.
"We have already conducted clinical trials on the safety of VivaGel in sexually inactive women and men, but this is the first time the product will be used in sexually active young women, one of our target populations. This study, in addition to the usual safety data, will collect valuable information regarding the product's use an acceptability in the consumer setting," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.
"The data from this trial will provide information of value to the development of VivaGel for all indications, including preventing the spread of genital herpes," added Dr Fairley.
The study will enroll 40 sexually active, HIV-negative women aged 18 to 24 years.
Participants will be randomly assigned to one of two study groups. One group will apply VivaGel twice a day for two weeks and the other will apply a placebo gel. The safety of VivaGel compared with the placebo will be assessed by laboratory tests and clinical examination of the participants.
Product acceptability assessments in the trial will provide very useful and productspecific preliminary information to add to the growing body of data supporting the attractiveness of topical gel microbicides in this consumer group.
The importance of topical microbicides is highlighted by statistics from UNAIDS and the U.S. Centers for Disease Control and Prevention that show 48 percent of the 39.5 million people living with HIV/AIDS are women, and among 15- to 24- year-olds with HIV, females account for 60 percent. In the U.S., 43 percent of AIDS cases in the 13- to 19-year-old age group are female.
About Microbicides
Vaginal microbicides are applied topically to the surface of the vagina and are designed to reduce or prevent the sexual transmission of HIV and other sexually transmitted infections. VivaGel is the subject of two active INDs with the US FDA. The product shows significant protection from HIV and HSV infection in animals, and has shown to be well tolerated in healthy, sexually abstinent men and women. VivaGel also has a potent contraceptive effect in animals.
About Starpharma Holdings Limited
Starpharma Holdings Limited (ASX:SPL, OTCQX: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 (DNT) 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.
Starpharma's proprietary dendrimer platform, which includes Priostar, also has potential in targeted diagnostics and in drug delivery for a wide variety of drugs. Improvements including enhanced solubility, targeting and reduced toxicity have been demonstrated for a number of existing drugs. More broadly the company, via DNT, is 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. 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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