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NIH FUNDS CLINICAL DEVELOPMENT OF VIVAGEL FOR GENITAL HERPES.


Starpharma Holdings Limited (USOTC: SPHRY; ASX ASX

See: Australian Stock Exchange
: SPL), Melbourne, Australia, has signed an agreement with the National Institute of Allergy and Infectious Diseases (NIAID NIAID National Institute of Allergy and Infectious Diseases. ), part of the National Institutes of Health (NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
), 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. . 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 A means of protection is some contract or guarantee of security for body or property. It is usually achieved, in a modern state society, by agreeing to some social contract including a monopoly on violence, e.g. ", said Dr John Raff, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 investigationa l new drug (IND) application for VivaGel(TM) for prevention of genital herpes with the US Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). 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 Coordinates:  .

Genital herpes is recognized as a key health concern in the US where it is one of the most prevalent sexually transmitted diseases Sexually transmitted diseases

Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely
. It is estimated that genital herpes currently infects between 15% and 25% of adults in industrialised Adj. 1. industrialised - made industrial; converted to industrialism; "industrialized areas"
industrialized

industrial - having highly developed industries; "the industrial revolution"; "an industrial nation"
 countries with the incidence projected to rise drastically in the next decade. In the US alone, approximately 50 million Americans are already infected.

Further Information

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 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-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 suppositories,
n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum.
 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 Herpes simplex virus
A virus that can cause fever and blistering on the skin, mucous membranes, or genitalia.

Mentioned in: Conjunctivitis


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 billi on 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.

For more information, visit http://www.starpharma.com.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Worldwide Biotech
Date:Jun 1, 2006
Words:747
Previous Article:SYNGENTA TO INVEST IN VENTURE FUND FOCUSED ON PLANT SCIENCE.
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