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September
18, 2002
USHERCELL
LEADS MICROBICIDE RESEARCH
WITH CONRAD
ADDITIONAL
FUNDING WILL ACCELERATE RESULTS
Toronto, Ontario, September 18, 2002
-- Polydex Pharmaceuticals Ltd. (NASDAQ:POLXF)
announces continued progress in the development of Ushercell,
the patented lead development product for Polydex. Ushercell
has completed three Phase I/II clinical trials and further
Phase I/II clinical trials are ongoing. Ushercell is nearing
late-stage, Phase III human clinical trials planned for fiscal
2004 under the direction of CONRAD (formerly known as Contraceptive
Research and Development).
Ushercell is a high-molecular-weight cellulose
sulphate compound developed initially as a contraceptive,
which has also shown promise, in vitro, for prevention of
the transmission of sexual diseases.
On August 28th, 2002, the Bill and Melinda Gates
Foundation furthered their commitment to HIV prevention and
contraception as it announced a series of grants, $11.9 million
of which was awarded to CONRAD. The Gates Foundation cites
recommendations included in Global Mobilization for HIV Prevention
- A Blueprint for Action, a comprehensive plan of action to
prevent 29 million HIV infections between now and 2010 through
new technologies and by scaling up existing prevention tools
and strategies.
"This grant will enable CONRAD's CICCR
project to accelerate research, development and clinical testing
of innovative new technologies. Microbicidal gels hold the
promise of both disease prevention and contraception, each
a vital need in developing countries", said Michael J.K.
Harper, Ph.D., Sc.D., director of CICCR and the Global Microbicide
Project (GMP).
Dr. Harper further added: "The new award
from the Gates Foundation provides funding for clinical trials
of hormonal contraception for men, and also for testing the
contraceptive efficacy, when used vaginally, of several microbicides
under development. The most advanced candidate for such a
clinical trial is Ushercell, and it is anticipated that a
contraceptive efficacy trial could commence in mid- to late-
2003".
"Just over a month ago, in July of this
year, the US Agency for International Development gave a $60
million grant to the Eastern Virginia Medical School's program
called CONRAD in order to develop contraceptives and products
to fight AIDS. The federal agency gave CONRAD $30 million
in 1998 for five years and now has increased that to $90 million
through 2008. Nearly 60 percent of the money will go toward
fighting HIV", said CONRAD Director, Dr. Henry Gabelnick.
CONRAD was established in 1986 with funding
from the U.S. Agency for International Development, and supported
by the public sector. It's mission is to develop new contraceptive
and subsequently antimicrobial agents that specifically address
the reproductive needs and issues of women and men in less
developed countries. CONRAD directs and funds the extensive
research, regulatory and clinical trial requirements as well
as related product development activities for Ushercell. CONRAD's
funding for Ushercell is provided through CONRAD's Consortium
for Industrial Collaboration in Contraceptive Research (CICCR)
which commenced operations on October 1, 1995 with initial
funding from Rockefeller Foundation and subsequently the United
Nations Population Fund, and the Mellon, Hewlett, Packard
and Gates Foundations, as well as the Global Microbicide Project
(GMP) established in 2000 and funded by the Gates Foundation.
The Topical Prevention of Conception and Disease
(TOPCAD), of Rush University in Chicago, IL have assisted
in the development of Polydex's Ushercell since conceptualization.
TOPCAD, established in 1993 at Rush-Presbyterian-St. Luke's
Medical Center and the University of Illinois at Chicago,
IL, aims at developing vaginal antimicrobial contraceptive
compounds and formulations. Scientists from various universities
and health organizations in the USA, Canada, Brazil and India
participate in the Program.
The strategic alliance which Polydex has with
CONRAD, as well as the licensing partnership with TOPCAD and
Rush University have enabled Polydex to make significant strides
forward in the development of this important compound, bringing
extensive intellectual and financial resources devoted to
the development of microbicides to bear on this project. Through
these alliances, Polydex has been able to engage the services
of specialty contractors to assist in the GMP synthesis and
scale-up of Ushercell as an active pharmaceutical ingredient.
It is anticipated they will also assist in the development
and supply of product required for large-scale human phase
III clinical studies and ultimately commercial use. Polydex
has also retained the services of several consultants with
expertise in pharmaceutical product development and business
development and licensing.
The terms of the strategic alliance Polydex
has with CONRAD, call for CONRAD to fund and conduct all the
required clinical research studies for the development of
Ushercell as a pharmaceutical product, and secure FDA approvals
for all necessary IND protocols. CONRAD provides critical
project management expertise. CONRAD is also funding the pre-NDA
toxicology studies, the GMP synthesis and scale-up of Ushercell
as an active pharmaceutical ingredient and the GMP development
and supply of product for the clinical studies. Polydex retains
all rights to commercialization in the private sector for
Ushercell, and plans to supply product on a reasonable cost-plus
basis for the public sector requirements.
Polydex Pharmaceuticals Ltd., based in Toronto,
Ontario, Canada, is engaged in the research, manufacture and
marketing of biotechnology-based products for veterinary and
human pharmaceutical industries worldwide. It is Polydex's
mandate to research, develop and market veterinary pharmaceutical
products in a hands-on (concept to consumer) fashion. However,
the business approach differs with development of their human
pharmaceutical pipeline. Here, the mandate is to research
and license out potential products to valued partners for
development, thereby minimizing R&D expenditures while
retaining a royalty revenue stream from successful products.
This is the reason that the search for development partners
is so important, and is an integral part of all of the potential
human pharmaceutical products in the Polydex pipeline.
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. Actual events or
results may differ materially from the Company's expectations,
which are subject to a number of known and unknown risks and
uncertainties including but not limited to changing market
conditions, future actions by the U.S. Food and Drug Administration
or equivalent foreign regulatory authorities as well as results
of pending or future clinical trials. Other risk factors discussed
in the Company's filings with the United States Securities
and Exchange Commission may also affect the actual results
achieved by the Company.
CONTACT:
Polydex Pharmaceuticals Limited
George G. Usher, President
(416) 755-2231
or e-mail: gu-dextran@rogers.com
Investor
Relations
North Arm Capital Services
Linda Hughes, Toll-free 1-877-945-1621
or e-mail: Linda@northarm.com
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