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March
16, 2004
POLYDEX
ANNOUNCES THAT CONRAD
HAS INITIATED CONTRACEPTIVE CLINICAL TRIALS OF USHERCELL WITH
FUNDING FROM THE BILL AND MELINDA GATES FOUNDATION
ADDITIONAL INTERNATIONAL TRIAL PREPARATIONS UNDERWAY
TO ASCERTAIN
EFFECTIVENESS OF USHERCELL AS A TREATMENT OF BACTERIAL VAGINOSIS
Toronto, Ontario, March 16, 2004 -- Polydex Pharmaceuticals
Limited (NASDAQ:POLXF) (BSE:PXL) is pleased to provide
this clinical trial update on Ushercell, its leading human
pharmaceutical compound, envisioned for topical vaginal use
primarily in the prevention of transmission of AIDS and other
sexually transmitted diseases, as well as unplanned pregnancies.
Two phase II contraceptive clinical studies were recently
initiated by CONRAD and Family Health International. The studies
will be conducted by the California Family Health Council
in Los Angeles, CA, and their satellite clinical sites.
In a press release dated January 21, 2004, the Company announced
the commencement of a non-comparative contraceptive effectiveness
trial for Ushercell, and is pleased to announce that a further
Phase II comparative contraceptive efficacy study of Ushercell
was initiated in February. One hundred fifty heterosexual
couples desiring pregnancy, but willing to postpone conception
by one menstrual cycle, will be randomized between the placebo
gel and Ushercell groups. The study is expected to be complete
by the end of the year, with a report issued in 2005.
Ushercell, a contraceptive gel with antimicrobial properties,
enjoys continued support from the prestigious research group
CONRAD, advancing this compound through extensive safety and
tolerance clinical trials, while providing the necessary funding.
Funds from the Bill & Melinda Gates Foundation are being
provided to CONRAD for the phase II clinical studies and supplies.
CONRAD has provided the FDA with several clinical and non-clinical
updates pursuant to the Development Plan for Ushercell. One
hundred thousand individual-dose units of Ushercell have been
manufactured to supply the contraceptive efficacy trials.
Additionally, Management intends to initiate funding of a
new research program into the possible use of Ushercell as
a treatment for Bacterial Vaginosis. This research program
was recommended in a report published by an international
team of researchers, led by Dr. Jose Simoes and Dr. Lourens
Zaneveld at the Department of Obstetrics and Gynecology, State
University of Campinas, Sao Paulo, Brazil, and Rush-Presbyterian-St.
Luke's Medical Center in Chicago, Illinois, with additional
support from the Fundacao de Amparo a Pesquisa do Estado de
Sao Paulo (FAPESP), Brazil, and continued support from Ushercell's
leading research team at CONRAD. The research was conducted
to evaluate how Ushercell affected the growth of G. vaginalis
and anaerobes commonly associated with Bacterial Vaginosis.
The in vitro research resulted in a report, (Simoes J et
al. Antimicrobial Agents and Chemotherapy, 46(8): 21692-2695,
2002) which indicated that Ushercell is effective at inhibiting
bacteria commonly associated with Bacterial Vaginosis. BV,
one of the most common vaginal disorders among reproductive-age
women, arises when the normal balance of "good"
and "bad" bacteria in the vagina goes awry, and
harmful bacteria are allowed to thrive. The cited report included
assessment of concerns that regular use of vaginal microbicides
could disrupt this balance and enhance women's odds of contracting
BV, and concluded that the use of Ushercell eliminated that
concern, prompting recommendations for further testing of
Ushercell as a treatment for BV, as well as a prevention method.
The progress in the development of microbicides will be reviewed
by leading scientists and developers from around the world
at a biennial event, Microbicides 2004, to be held during
the last week of March 2004, in London England. Researchers
from the Ushercell development team at CONRAD and Mr. George
Usher, President and CEO of Polydex, will be in attendance
at that conference.
Polydex Pharmaceuticals Limited, based in Toronto, Ontario,
Canada, is engaged in the research, manufacture and marketing
of biotechnology-based products for the human pharmaceutical
market, and also manufactures bulk pharmaceutical intermediates
for the worldwide veterinary pharmaceutical industry. Please
visit our updated website at www.Polydex.com
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 United States 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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