NIH Funds Clinical Development of VivaGel(TM) for Genital Herpes

Apr 19, 2006, 01:00 ET from Starpharma Holdings Limited

    MELBOURNE, Australia, April 19 /PRNewswire-FirstCall/ --
     * NIH is providing funding for the clinical development of VivaGel(TM) for
       genital herpes
     * Starpharma now has substantial development support from NIH for
       VivaGel(TM) in key indications, HIV and genital herpes
     * Funding is non-dilutive for shareholders and has no negative impact on
       the commercial returns that Starpharma will receive from VivaGel(TM)
     Starpharma Holdings Limited (USOTC: SPHRY; ASX: SPL) today signed an
 agreement with the National Institute of Allergy and Infectious Diseases
 (NIAID), part of the National Institutes of Health (NIH), to fund a
 clinical trial to test the use of VivaGel(TM) in the prevention of genital
 herpes. Genital herpes is the second indication for which VivaGel(TM) is
 being developed.
     This latest support from the NIH is in addition to a previously
 announced US$20.3 (A$26m) million funding provided by the NIH to support
 the development of VivaGel(TM) 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(TM).
     "This additional support and validation for VivaGel(TM) from the NIH is
 great news for Starpharma. Genital herpes represents a significant market
 opportunity for VivaGel(TM) 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(TM) and further de-risks the
 development path for VivaGel(TM). 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 the
 first half of 2006. As part of this support, NIAID will also act as sponsor
 of an additional investigational new drug (IND) application for VivaGel(TM)
 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 (USOTC: SPHRY; ASX: SPL) leads the world in
 the application of nanotechnology to pharmaceuticals. The Company's lead
 product in development is VivaGel(TM) (SPL7013 Gel), a vaginal microbicide
 designed to prevent the transmission of STIs, including HIV and genital
     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-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
     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.
      Rebecca Wilson
      T: +61 2 9237 2800
      M: +61 417 382 391
      John Raff
      Chief Executive Officer
      T: +61 3 8532 2701
      Jackie Fairley
      Chief Operating Officer
      T: +61 3 8532 2715
      Ben Rogers
      Company Secretary
      T: +61 3 8532 2702

SOURCE Starpharma Holdings Limited