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October
19, 2004
PHASE
III USHERCELL (CELLULOSE SULFATE) TRIAL
FOR HIV PREVENTION UNDER WAY
Toronto, Ontario, October 19, 2004 -- Polydex Pharmaceuticals
Limited (NASDAQ:POLXF) (BSE:PXL) announced the commencement
of a Phase III clinical trial of Ushercell (Cellulose Sulfate)
a microbicidal gel which is being tested for its effectiveness
in the prevention of HIV and other sexually transmitted infections.
In ongoing contraceptive studies, Cellulose Sulfate, a high
molecular weight polymer, may also prove to be a major advance
in fertility regulation. Preclinical and clinical studies
have already demonstrated its high level of safety. Laboratory
tests revealed the potential of Cellulose Sulfate to act as
an effective guard against both unwanted pregnancies and against
sexually transmitted infections, including HIV/AIDS, gonorrhea,
chlamydia and herpes 1 and 2.
"The initiation of this Phase III trial is an important
milestone in celebrating our successful partnership with CONRAD,
as Ushercell becomes the first of our products to reach this
critical stage in product development," said George Usher,
President and CEO of Polydex.
CONRAD, located in Arlington, VA, has played an instrumental
role in developing Cellulose Sulfate with the support of USAID
and private foundations, and in clinical collaboration with
Family Health International, WHO and NIH. CONRAD, which was
established and funded by USAID at the Eastern Virginia Medical
School, has focused on developing safe, effective, acceptable
and affordable methods of contraception and microbicides for
the prevention HIV/AIDS and other sexually transmitted infections.
Jeff Spieler, Chief of USAID's Research Technology and Utilization
Division of the Bureau for Global Health said: "USAID's
highest priority in microbicide research and development is
to undertake the trials to demonstrate that a safe product
can reduce the risk of acquiring HIV. Microbicides represent
the best chance we have over the next several years to provide
a life-saving HIV prevention technology for women who cannot
negotiate condom use, including women whose only risk factor
is their husband's or partner's lack of faithfulness."
In the summer of 2004, the FDA gave permission for the first
Phase III HIV prevention study of Cellulose Sulphate to be
carried out by FHI in two sites in Nigeria. A second study's
protocol has just been approved by the FDA and will be conducted
by CONRAD in several countries with a high incidence of HIV
infection.
The randomized placebo-controlled studies will assess the
effect of 6% CS gel on HIV transmission among HIV negative
women, who are at high risk of contracting HIV through intercourse.
The primary objective of the trials is to determine the effectiveness
of 6% CS gel (3.5mL) compared to a placebo, in preventing
male-to-female vaginal transmission of HIV; the secondary
objective is to determine the effectiveness of CS gel, compared
to a placebo gel, in preventing male-to-female transmission
of Neisseria gonorrhoeae and Chlamydia trachomatis.
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. 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:
Investor
Relations
North Arm Capital Services
Linda Hughes, Toll-free 1-877-945-1621
or e-mail: Linda@northarm.com
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