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August
1, 2001
POLYDEX
REPORTS ADVANCEMENT IN DEVELOPMENT OF TECHNOLOGY FOR LUNG
DISORDERS
TORONTO,
Ontario, August 1, 2001 --
Polydex Pharmaceuticals Ltd. (NASDAQ:POLXF) (BSE:PXL) is pleased
to take this opportunity to report on progress being made
in the development of Usherdex, a carbohydrate technology
expected to be useful in alleviating breathing difficulties
experienced by patients with such diseases as Cystic Fibrosis
(CF), Chronic Obstructive Pulmonary Disease (COPD) and other
lung disorders.
Usherdex,
the first of our patented human pharmaceuticals to be sublicensed
out to a strategic partner for development, has continued
to show promise in the laboratory. In fact, BCY LifeSciences
Inc. has reported raising over $4 million (CDN) toward the
development of this promising compound, which could ultimately
alleviate breathing difficulties experienced by patients with
cystic fibrosis, chronic bronchitis, Chronic Obstructive Pulmonary
Disease (COPD), and other lung ailments.
A
number of accomplishments have been achieved in preparation
for Phase I human clinical testing. BCY has announced the
successful fractionation of a low molecular weight dextran
and the completion of the bio-assay of these fractions. This
enabled BCY to complete a critical step in its preparation
for the filing of an IND (Investigational New Drug) application.
Since
then, BCY LifeSciences has announced favorable results of
toxicology testing, wherein an aerosol mist form of Usherdex
was administered to rats and dogs, in dose levels well above
the anticipated human dose and for dosing periods of up to
28 days. No signs of toxicity or other side effects were observed
in either species.
BCY
LifeSciences Inc. reported, on July 16, 2001, having filed
an IND (Investigative New Drug) application in Canada to seek
approval to conduct a Phase I clinical trial using Usherdex,
under development with BCY by the name DCF 987. "This
is a significant step for BCY LifeSciences" remarked
Lorne Meikle, BCY's President & CEO. "We have only
had the technology under license for fifteen months. During
this short period, we have identified a lead compound, completed
toxicology studies and with the filing of the IND, we now
will complete our preparations for our Phase I clinical trial."
In anticipation of successful Phase I human clinical testing,
BCY is already planning to commence Phase II clinical trials
in the first half of 2002.
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.
Polydex
will share in a royalty stream on revenues generated from
sales of a successful product. New products entering the market
for cystic fibrosis patients have been shown to generate up
to $120 million (US) in annual sales. Therefore Usherdex could
ultimately produce a significant revenue stream. This is an
excellent example of the successful implementation of the
partnering mandate, wherein the Company could benefit greatly,
with a minimal outlay of capital for this drug's development.
BCY
LifeSciences Inc. is a Canadian development stage biopharmaceutical
company dedicated to acquiring and developing innovative pharmaceutical
products or technologies that serve unmet medical needs and
that offer near term licensing opportunities with reduced
scientific/clinical risk. BCY Lifesciences is a publicly trading
company on the CDNX exchange under the symbol BCY.
Polydex
Pharmaceuticals Ltd., based in Toronto, Ontario, Canada, is
engaged in the research, manufacturing and marketing of biotechnology-based
products for human and veterinary pharmaceutical industries
worldwide. Polydex is traded on the Nasdaq SmallCap Market
under the symbol POLXF and on the Boston Stock Exchange under
PXL.
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.
Please
visit : www.Polydex.com
and www.BCYLifesciences.com
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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