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June
24, 2003
CONRAD'S
DEVELOPMENT PLAN FOR USHERCELL
MOVES FORWARD IN CLINICAL TRIALS
Polydex
Outsources the Production of 2.5 Million Doses
of AIDS Contraceptive Gel
Toronto, Ontario, June 24, 2003 -- Polydex Pharmaceuticals
Limited (NASDAQ:POLXF) (BSE:PXL) reported today that it
has received an updated Development Plan from its' collaborative
research partner, CONRAD, and provides the following overview
of current and planned development of Ushercell. CONRAD (www.CONRAD.org),
with funding from various private and public sector donors,
has been successful in obtaining further development collaboration
from Family Health International (FHI), World Health Organization
(WHO) Centers for Disease Control (CDC), and
HPTN (HIV Prevention Trials Network).
George Usher, Chairman, President and CEO of Polydex is pleased
with the continued progress in the development of Ushercell.
"Considering that it usually takes about $500 million
dollars and twelve to fifteen years to advance a product from
primary studies to FDA approval, we are very pleased that
Ushercell has garnered such great support from the research
community and their philanthropic supporters. We could not
have come this far without them. Ushercell, now ten years
in the making, is preparing to enter late stage clinical trials."
Ushercell is the Company's leading human pharmaceutical compound,
a high molecular weight cellulose sulfate envisioned for topical
vaginal use primarily in the prevention of transmission of
AIDS and other sexually transmitted diseases, as well as unplanned
pregnancies. Studies to assess efficacy in contraception and
prevention of HIV and other STD's, are scheduled to begin
in late 2003, and will require approximately 2.5 million doses
of the developed compound.
The GMP certified (Good Manufacturing Practices) production
firms of Organichem Corporation, (www.organichem.com)
a world leader in contract manufacturing for bulk active pharmaceuticals
and advanced intermediates, and Patheon Inc. (www.patheon.com),
a leading global provider of outsourced drug development and
manufacturing services, are expected to produce the individual
dosage units for these clinical trials.
Ushercell continues to show positive results in ongoing Phase
I/II safety, tolerance and acceptability studies, in various
domestic and international clinical sites. In the recent Development
Plan provided to Polydex by CONRAD, four additional phase
I/II clinical trials are reported as being underway in Uganda,
Nigeria, India, Cameroon and the United States. The final
analysis is currently underway from a further completed trial
conducted in the United States, and additional Phase I/II
trials are being planned for sites in Belgium and the United
States.
Highlights of certain clinical studies included
in CONRAD's Development Plan are as follows:
- A clinical study of 48 sexually active women conducted
in collaboration with FHI in Cameroon, has
been completed. The final report is expected in 2003.
- A study in which MRI was used to document the spreading
of Ushercell and the impact of volume, ambulation, and parity
on spreading is completed and in analysis, with a final
report expected in 2003.
- In a study underway in collaboration with WHO, participant
participation has been completed in Uganda and Nigeria and
is ongoing India. The final analysis of this study, which
enrolled 180 healthy women, is expected in 2003.
- Recruitment has begun for a study being carried out in
collaboration with HPTN, to establish the
safety of and tolerance of Ushercell among HIV-infected
women prior to entering into clinical trials designed to
assess HIV prevention. This study will involve 96 women
and up to 48 male partners in four sites in the United States
and participation is expected to be complete in 2003.
- A study at two sites in the U.S. and one in the Dominican
Republic is underway. The study will assess the safety of
twice daily use of Ushercell by 60 women, half of whom engage
in intercourse during the study. The study is expected to
be completed in 2003.
- A tolerance study of 42 HIV-infected men is being planned
in collaboration with the Institute of Tropical Medicine,
in Belgium, to begin in 2003.
- A study is planned in collaboration with the University
of California at San Francisco to be conducted in
180 sexually active women in Zimbabwe. It will assess the
safety and acceptability of Ushercell used with a diaphragm,
and should begin in 2004.
- Clinical trials demonstrating contraceptive activity of
Ushercell are planned for various sites in the United States
and abroad to begin in 2003. Several hundred participants
at risk for pregnancy are expected to use Ushercell for
periods of 6 months and 12 months respectively.
- In collaboration with FHI, clinical trials
to assess the effect of Ushercell on vaginal HIV acquisition
in sexually active women at high risk of HIV are to begin
in 2004. This study expects to enroll more than 2,000 women.
Please visit our updated website at www.Polydex.com
Polydex Pharmaceuticals Ltd., based in Toronto, Ontario, Canada,
is engaged in the research, manufacture and marketing of biotechnology-based
products. Polydex's business approach with respect to the
development of the human pharmaceutical pipeline 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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