NIH Funds Clinical Development of VivaGel™ for Genital Herpes
Ø NIH is providing funding for the clinical development of VivaGel™ for genital herpes
Ø Starpharma now has substantial development support from NIH for VivaGel™ in key indications, HIV and genital herpes
Ø Funding is non-dilutive for shareholders and has no negative impact on the commercial returns that Starpharma will receive from VivaGel™
Melbourne, Australia, 20 April, 2006 – Starpharma Holdings Limited (ASX:SPL, USOTC:SPHRY) today signed an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), to fund a clinical trial to test the use of VivaGel™ in the prevention of genital herpes. Genital herpes is the second indication for which VivaGel™ is being developed.
This latest support from the NIH is in addition to a previously announced US$20.3 million (A$26m) funding provided by the NIH to support the development of VivaGel™ for the prevention of HIV. In both cases funding is non-dilutive for shareholders and has no negative impact on the commercial returns that Starpharma will receive from VivaGel™.
“This additional support and validation for VivaGel™ from the NIH is great news for Starpharma. Genital herpes represents a significant market opportunity for VivaGel™ as there is currently no cure and no sufficiently wide-spread, effective means of protection”, said Dr John Raff, CEO of Starpharma. “This new agreement with NIAID broadens the development opportunities for VivaGel™ and further de-risks the development path for VivaGel™. We judge that it would have cost millions of dollars to achieve this strategic product advance by other means.”
The NIAID-funded trial will be conducted at established clinical sites in the US and Kenya. It is anticipated that the trial will commence in mid-2006. As part of this support, NIAID will also act as sponsor of an additional investigational new drug (IND) application for VivaGel™ for prevention of genital herpes with the US Food and Drug Administration (FDA). Starpharma will be co-sponsor of the clinical study, and the Principal Investigator will be Craig Cohen, MD, of the University of California, San Francisco.
Genital herpes is recognized as a key health concern 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 drastically in the next decade. In the US alone, approximately 50 million Americans are already infected.
Starpharma Holdings Limited (ASX:SPL, USOTC:SPHRY) leads the world in the application of nanotechnology to pharmaceuticals. The Company’s lead product in development is VivaGel™ (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
VivaGel™ 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™ (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-signaling and targeting groups are added to allow location of specific cell type, such as cancer cells).
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 afford protection for varying periods, from several hours up to days. Microbicides may also be designed to have a contraceptive function.
Genital herpes: A recurrent, lifelong viral infection caused by the sexually transmitted herpes simplex virus type-2 (HSV-2). It is one of the most prevalent STIs, estimated to infect between 15% and 25% of male and female adults in developed countries. This figure is expected to rise to about 39% for males and 49% for females by 2025, unless effective preventive measures are found to reverse the trend. Herpes is estimated to affect one in six adults in America and new cases cost more than US$1.5 billion each year. The figures for Australia are similar with an estimated one in six adults suffering from genital herpes (3.4 million people).
HSV-2 infection has a marked effect on a sufferer’s quality of life. The virus is highly contagious and women appear to be at greater risk of infection than men. HSV-2 infection can make people more susceptible to infection by HIV and increase the transmission rate of HIV. If transmitted from mother to baby, the disease has very serious consequences.
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.