|
January
21, 2004
POLYDEX'S
USHERCELL COMPLETES FURTHER PHASE I TRIALS PROCEEDS TO PHASE
II CONTRACEPTIVE TRIALS
Toronto, Ontario, January 21, 2004 -- Polydex Pharmaceuticals
Limited (NASDAQ:POLXF) (BSE:PXL) is pleased to provide
this update on current research and development projects involving
its Ushercell and Usherdex-4 products.
Ushercell, a cellulous sulfate gel formulation developed
by Polydex, is envisioned for topical vaginal use primarily
in the prevention of unplanned pregnancies as well as the
transmission of AIDS and other sexually transmitted diseases.
With the assistance and financial support of its collaborative
research partner CONRAD, several Phase I safety, tolerance
and acceptability clinical trials were successfully completed
in Cameroon, Uganda, Nigeria, India, Belgium, the United States
and the Dominican Republic during 2003. The data from these
trials has shown consistent safety and tolerance with respect
to the product, and the reports include recommendations to
proceed with Phase II and III efficacy trials.
A Phase II non-comparative contraceptive effectiveness trial
for cellulose sulfate gel was initiated this month by CONRAD.
Two hundred heterosexual couples who currently do not desire
a pregnancy and who are at low risk for sexually transmitted
infections have agreed to use Ushercell as their contraceptive
product preceding each act of intercourse for six months.
A study report is expected in mid-2006.
A Phase II comparative contraceptive efficacy study of cellulous
sulfate gel is expected to begin in February, to be conducted
by CONRAD, Family Health International, and the California
Family Health Council in Los Angeles, CA, and their satellite
clinical sites. 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. Couples will be instructed to use the products for
every act of vaginal intercourse and to have at least two
acts during days 10-15 of the female participant's menstrual
cycle and at least one act during days 16-20 of her menstrual
cycle. The study is expected to be completed by the end of
this year, with a report issued in 2005.
Ushercell has enjoyed unwavering support and financial assistance
from the prestigious research group CONRAD (www.conrad.org),
which has been successful in obtaining funding from various
private and public sector donors, as well as the collaborative
efforts of Family Health International (FHI), World Health
Organization (WHO) Centers for Disease Control (CDC) and HPTN
(HIV Prevention Trials Network). Funds from the Bill &
Melinda Gates Foundation are being provided to CONRAD for
Ushercell's Phase II clinical studies and supplies.
George Usher, President and CEO of Polydex is pleased that
Ushercell was accepted for this support by CONRAD and notes
that "Ushercell would still be in our laboratories as
a pipe dream if it were not for CONRAD, their highly skilled
and motivated team of clinicians, research and development
scientists, pre-clinical and product development abilities,
and their ability to demonstrate continued development of
successful compounds to their philanthropic supporters. A
topical contraceptive method, with possible antimicrobial
activity for the prevention of sexually transmitted diseases,
has long been a goal for CONRAD and with their continued support
may be an achievable reality within the next several years."
CONRAD's Development Plan for Ushercell calls for commencement
of large-scale, efficacy trials of Ushercell for both contraceptive
and HIV prevention indications in 2004. 100,000 individual-dose
units of the product have already been manufactured to supply
the contraceptive efficacy trials. Production of several million
individual-dose units has started in preparation for phase
III HIV prevention clinical studies. The scopes of the Phase
II and III clinical programs currently planned by CONRAD are
expected to take several years and will require additional
funding to complete.
CONRAD has indicated that Ushercell remains one of the leading
microbicides in development and maintains confidence that
funding will become available to bring this product to market
as more awareness and international concern over the HIV/AIDS
pandemic is sourced. Dr. Gabelnick, Director of CONRAD, says
that "funding remains a constant challenge but we are
very dedicated to finding a method of preventing the millions
of new HIV infections every year and Ushercell is furthest
along in our pipeline to attain that goal."
Usherdex-4, now called DCF987, is a carbohydrate technology
intended to alleviate breathing difficulties experienced by
patients with such diseases as Cystic Fibrosis (CF), Chronic
Obstructive Pulmonary Disease (COPD) and other lung disorders.
DCF987 has been advanced through pre-clinical and human clinical
trials by BCY LifeSciences Inc. (www.bcylifesciences.com)
pursuant to a sub-licensing agreement.
2003 saw the completion of both Phase I and Phase II human
clinical trials involving adult cystic fibrosis patients in
several medical centers across Canada. Post clinical trial
analysis indicated that DCF987 was well tolerated and showed
a number of positive trends including improved FEV (1) (forced
expiratory volume in one second), a measure of lung function,
and the reduction of Pseudomonas aeruginosa bacterial load
in patient sputum, which if proven in the next development
stage, would be meaningful to a cystic fibrosis patient.
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
|