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May
3, 2005
CONRAD
RECEIVES $24 MILLION FROM GATES FOUNDATION AND USAID FOR HIV
MICROBICIDE TRIALS
MULTI-COUNTRY PHASE III CLINICAL TRIALS TO TEST MICROBICIDES
TO PREVENT HIV INFECTION
Arlington, VA (May 3, 2005) The CONRAD program of
the Eastern Virginia Medical School today announced that it
has received a $12M grant from the Bill & Melinda Gates
Foundation, with $12 million in matching funds committed by
the US Agency for International Development (USAID), for a
total of $24M. This grant plus the USAID award will allow
two multi-country Phase III clinical trials of a product to
prevent the transmission of HIV/AIDS.
The main goal of the project is to determine if a vaginal
microbicide candidate is an effective and safe method for
preventing HIV transmission. CONRAD plans to meet this goal
by completing two Phase III HIV prevention trials with a gel
consisting of 6% cellulose sulfate (CS), also known as Ushercell®,
developed by CONRAD in collaboration with Polydex Pharmaceuticals
Limited, a publicly quoted (POLXF, Nasdaq) Canadian company.
One trial, implemented by CONRAD, will be conducted in India
and four African countries. This trials will be funded equally
by the Gates Foundation and USAID. The other trial, initiated
in late 2004 in Nigeria in collaboration with Family Health
International (FHI), is entirely supported by USAID.
Previous funding from the Gates Foundation and USAID provided
support for studies that demonstrated an excellent safety
profile for CS. Henry Gabelnick, Ph.D, Director of CONRAD
said, "An urgent need exists to provide additional means
of prevention of HIV/AIDS transmission as rapidly as possible.
Although male and female condoms can provide protection, they
are not used sufficiently and consistently. The availability
of a microbicide that can be used by a woman to protect herself
has a good probability of being this necessary alternative."
George Usher, President and CEO of Polydex Pharmaceuticals
Limited, said "My thanks and gratitude at this announcement
must go to the researchers and scientists at CONRAD for pursuing
the development of Ushercell as a potential microbicide, and
for garnering the considerable resources required over the
years to advance this leading hope for women to protect themselves
against sexually transmitted diseases and unwanted pregnancy."
The researchers hope that the completed trials will demonstrate
a significant decrease -- at least 50% -- in HIV incidence
among CS users compared to placebo users, and a measurable
reduction in incidence of gonorrhea and chlamydia. A 50% decrease
would be an enormous step towards reducing new infections
and cost savings -- based on mathematical modeling of 73 countries
with GDP of less than $1,200/year and all sub-Saharan countries,
a microbicide of 50% efficacy and 20% service coverage would
prevent 2.5 million new infections, leading to $3.7 billion
in direct cost savings to health systems and indirect cost
savings through increased productivity.
CONRAD and FHI, the primary organizations conducting these
trials, have a long history of collaboration in microbicide
development and have put together an excellent team of researchers
to maximize the probability of a successful outcome.
The microbicide field has built an extraordinary amount of
scientific momentum, with several first-generation candidates
entering large-scale human trials around the world. At the
same time, new products, based upon recent advances in HIV
treatment, are already well into safety trials. Given current
scientific advancements, and the identification of a number
of potential microbicidal agents, an effective microbicide
could be developed by the end of the decade, and once available,
could well change the course of the AIDS epidemic.
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CONRAD is a cooperating agency of USAID committed to improving
reproductive health by expanding the contraceptive choices
of women and men and by helping to prevent the transmission
of HIV/AIDS and other sexually transmitted diseases. CONRAD
is administered through the Department of Obstetrics and Gynecology
at Eastern Virginia Medical School (EVMS) in Norfolk, VA,
with the main office located in Arlington, VA.
Polydex Pharmaceuticals Limited, based in Toronto, Ontario,
Canada, is engaged in the research, development, manufacture
and marketing of biotechnology-based products for the human
pharmaceutical market, and also manufactures bulk pharmaceutical
intermediates for the worldwide veterinary pharmaceutical
industry.
Note: This press release may contain forward-looking
statements, within the meaning of the United States Securities
Act of 1933, as amended, and the United States Securities
Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals
Limited and Ushercell. Actual events or results may differ
materially from expectations, which are subject to a number
of known and unknown risks and uncertainties including but
not limited to results of pending or future clinical trials.
CONTACT:
CONRAD Contact:
Henry Gabelnick
703-276-3904
hgabelnick@conrad.org
Polydex Contact:
Linda Hughes
877-945-1621
Linda@northarm.com
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