|
|
NEWS Release
Wex Announces Clinical
Study for Tetrodin™/Reports on Progress with U.S. Pain Program
Date: August 26, 2004
Toronto Stock Exchange
Trading Symbol: WXI
http://www.wextech.ca
E-mail: wex@wextech.ca
Vancouver, August 24,
2004 - International Wex Technologies Inc. (TSX: WXI), a pharmaceutical
company developing drugs for the management of pain, today announced
that it has filed an amended study with Health Canada to conduct
a Phase II clinical trial in Canada for Tetrodin™ , for the treatment
of opioid drug withdrawal. The study was originally filed in 2002
and granted clearance by Health Canada to proceed. The amendment
includes new information gained from the Tectin™ Phase IIa study
in refractory cancer pain. In addition, the Company reported progress
on its global development plan for Tectin™, which is currently being
tested in a pivotal double-blind, placebo-controlled study in cancer
patients with refractory cancer pain.
"We are pleased to be
in a position to initiate our second clinical program derived from
our Tetrodotoxin-based platform technology," said Donna Shum , Chief
Operating Officer of WEX. "Given our stronger financial position
since our initial filing of the study in 2002, we are better equipped
to complete the study in a timely fashion. In addition, we believe
the amended protocol could generate important clinical results as
it reflects new information from the most current clinical and preclinical
data on Tetrodotoxin."
Opioid withdrawal
study - Tetrodin™
The Phase II study of Tetrodin™
is a double-blind, placebo controlled study evaluating the efficacy
and safety of Tetrodin™ in patients who use methadone and are physically
dependent upon opioid drugs. The primary endpoint of the trial is
to determine the efficacy of Tetrodin™ in decreasing the severity
of opioid withdrawal symptoms as determined by the Clinical Institute
Narcotic Withdrawal Assessment (CINA) score. Tetrodin™, a reversible
sodium channel blocker, has demonstrated a reduction of withdrawal
symptoms in preclinical and pilot clinical studies with the absence
of dependence-inducing properties.
Opioid dependence is characterized
by a withdrawal syndrome that occurs when opioid agonists are abruptly
discontinued. Withdrawal symptoms manifest in different degrees
of physical discomfort and include objective and subjective symptoms.
Managing withdrawal is a critical step in initiating many patients
who are opioid dependent into treatment. Traditional medical management
of opioid withdrawal involves the substitution of a long-acting
opioid for shorter acting opioids and gradual tapering.
Opioids are a family of
drugs that have morphine-like effects. Their primary medical use
is to relieve pain. When used occasionally under medical supervision,
there is little risk of addiction. However, opioids can also produce
euphoria, making them prone to abuse. According to the Centre for
Addiction and Mental Health, chronic use or abuse of opioids can
lead to psychological and physical dependence.
Tectin™
Update
In August, 2004 the Company,
its European partner, and its expert external consultants met with
the Food and Drug Administration ("FDA") to discuss clinical and
preclinical studies to date, of its lead product Tectin™ and to
seek advice on the Company's New Drug Application ("NDA") filing
strategy in the United States. The Company's strategy has been to
conduct studies in Canada and Europe according to the International
Committee for Harmonization ("ICH") guidelines. Having received
confirmation that the FDA will accept foreign studies, conducted
to ICH standards, as part of an NDA filing, the Company is encouraged
that its current efforts in Canada and Europe will be an important
part of the U.S. commercialization strategy.
Tectin™ is a drug designed
to treat moderate to severe pain, primarily as a reversible selective
sodium channel blocker. Tectin™ is being tested in a pivotal double-blind
placebo-controlled study in patients with refractory cancer pain.
Interim results from the Phase IIa clinical trial suggest that Tectin™
may have unique properties capable of combining rapid and lasting
analgesic effects without the morphine-like side effects characteristic
of many approved drugs for the management of moderate to severe
pain.
About International
Wex Technologies Inc.
International Wex Technologies
Inc. is a pharmaceutical company dedicated to the discovery of new
therapeutic agents for the treatment of moderate to severe pain,
symptom relief associated with addiction withdrawal from opioid
abuse, and medicines designed for local and regional anaesthesia.
The Company's principle business strategy is to derive drugs from
naturally occurring toxins and develop proprietary products for
North American, European and international markets. The Company
also generates revenues from sales of generic products manufactured
at its facility in China .
Forward Looking Statement
Disclaimer
Statements in this
news release are forward-looking statements which may not be based
on historical fact, including without limitation statements containing
the words "believe", "may", "plan", "will", "estimate", "anticipates",
"intends", "expects" and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or developments
expressed or implied by such forward-looking statements. Such factors
include, among others, WEX's stage of development, product revenues
which are difficult to predict, foreign currency exchange risk,
additional capital requirements, risks associated with the completion
of clinical trials, the ability to protect its intellectual property
and dependence on collaborative partners. These factors should be
considered carefully and readers are cautioned not to place undue
reliance on such forward-looking statements. The company disclaims
any obligation to update any such factors or to publicly announce
the result of any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments.
Per: Donna Shum, Corporate
Secretary
|