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March
20, 2002
POLYDEX
PHARMACEUTICALS REPORTS PUBLISHED SAFETY STUDIES SHOWING POSITIVE
RESULTS IN SAFETY, TOLERANCE AND ACCEPTABILITY STUDIES OF
USHERCELL
Toronto, Ontario, March 20, 2002 -- Polydex
Pharmaceuticals Ltd. (NASDAQ:POLXF) (BSE:PXL) reports
today on two additional clinical trials, showing positive
results in safety, tolerance and acceptability studies of
Ushercell .
"CONTRACEPTION" has recently published
two scientific papers, entitled CELLULOSE SULPHATE: TOLERANCE
AND ACCEPTABILITY OF PENILE APPLICATION, and SINGLE AND MULTIPLE
EXPOSURE TOLERANCE STUDY OF CELLULOSE SULPHATE GEL: A PHASE
I SAFETY AND COLPOSCOPY STUDY, which both discuss the various
aspects of safety, tolerance and acceptability of Ushercell,
a promising novel polysaccharide which has shown, in vitro,
to provide contraceptive activity and, more importantly, to
protect against the transmission of sexually transmitted diseases,
including: Herpes simplex virus, Chlamydia trachomatis, and
the AIDS-causing Human Immunodeficiency Virus (HIV).
The strategic alliance which
Polydex has with the Contraceptive Research and Development
Program (CONRAD), as well as the licensing partnership with
TOPCAD and Rush University has enabled the Company 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 this project.
The manuscripts of the results
of these two additional Phase I trials, were authored by research
team members from CONRAD, California Family Health Council,
Inc., Family Health International (FHI), Research, Eastern
Virginia Medical School, and University of Pittsburgh and
Magee-Women's Research Institute. These trials were conducted
with the further support of the Global Microbicide Project.
George Usher, President and
CEO of Polydex, projects "with continuance of this exceptional
scientific support, Ushercell could become the leading candidate
to offer women a safe and effective method to discreetly control
their health options".
Sexually transmitted infections
and unwanted pregnancies pose a serious health risk in developed
and developing countries, and a vaginally applied gel is a
promising approach for preventing both. The objectives of
the separate male/female studies were to assess the degree
of irritation, safety, tolerance and acceptability of a product
in randomized, double-blinded Phase I studies of Cellulose
Sulphate gel (Ushercell), and two well-known over the counter
products; one, a lubricant, and the other a spermicide containing
nonoxynol 9.
All women in the analysis
completed the study, except for two participants who discontinued
early from the spermicide group for medical reasons relating
to irritation. After the first use of the assigned product,
there was significantly more evidence of irritation in both
the lubricant and spermicide groups. Throughout follow-up,
there was more evidence of irritation in the two control groups
not using Cellulose Sulphate, at a level that approached statistical
significance. Various comfort issues were explored and it
was determined that women with a need for contraceptive and/or
anti-microbial characteristics possibly would purchase a Cellulose
Sulphate gel product.
All men who were enrolled
completed the study; there were no unscheduled visits. Of
the four men who reported any symptoms and/or findings on
physical examination related to product use, only one participant
was in the Cellulose Sulphate group; he reported experiencing
infrequent minimal stinging. Most men experienced little or
no physical discomfort with their assigned products, although
more men in the Cellulose Sulphate group had nothing negative
to report when asked what they liked least about their assigned
product. Approximately 95% of the men in the Cellulose Sulphate
group reported that they would not object to their partner
using the gel, and 70% of the same group felt they would not
be able to tell if their partner was using the product. This
aspect will be key for women who want to use this type of
product discreetly, such as those who live in cultures where
negotiation of condom use is difficult, sometimes impossible.
The United States FDA has
approved additional clinical protocols for continued clinical
safety and efficacy studies. It is anticipated that large-scale
Phase III clinical studies will commence in 2003.
Polydex Pharmaceuticals Ltd.,
based in Toronto, Ontario, Canada, is engaged in the research,
manufacturing 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 ongoing relative to all of the potential
human pharmaceutical products in the Polydex pipeline.
Note: This
press release may contain forward-looking statements, within
the meaning of Section 27A 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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