NEWS Release
Pivotal Phase IIb/III
Trial of Tectin™ for Cancer Pain Begins
Date: May 5, 2004
Toronto Stock Exchange
Trading Symbol: WXI
http://www.wextech.ca
E-mail: wex@wextech.ca
Investigators involved in
the pivotal clinical trial of Tectin™ enrolled and dosed the first
of up to 150 patients that will participate in the study. It
is one of the largest Canadian clinical trials to evaluate the efficacy
and safety of a drug for treatment of medically refractory cancer
pain, and will take place in up to 25 treatment centres across Canada
.
Tectin™, a drug derived from
the puffer fish, also known as blow fish or fugu, has been developed
by Vancouver-based International Wex Technologies Inc. to block
slow sodium channel nocicipetive pain fibers in a highly selective
manner. Results from a recently completed open-label Phase IIa dose
finding study will be presented in a podium presentation by the
lead investigator, Dr. Neil Hagen, during the 2nd Joint Scientific
Meeting of the American Pain Society and the Canadian Pain Society
that will be held in Vancouver, B.C., on May 6-9, 2004 . As previously
announced, interim results from this study showed Tectin™ to be
safe and effective in refractory cancer pain with 68% of the test
subjects demonstrating a clinical response that lasted for longer
than two weeks in some patients. Based
on these promising results, the Company was encouraged to pursue
a larger trial to further confirm the effectiveness of the compound.
The current trial is a multicentre, randomized, double-blind
and placebo-controlled study designed to compare the efficacy and
safety of Tectin™ versus placebo in moderate to severe inadequately
controlled cancer-related pain.
The study is co-led by Dr.
Neil Hagen and Dr. Bernard Lapointe. Dr Neil Hagen is a nationally
respected leader in cancer pain assessment and management, who currently
heads the Division of Palliative Medicine, Department of Oncology,
and Faculty of Medicine, at the University of Calgary. Dr.
Bernard Lapointe is Chief, Palliative Care Division, Sir Mortimer
B Davis Jewish General Hospital Montreal and an Associate Professor,
Department of Oncology & Department of Family Medicine at McGill
University .
Dr. Benard Lapointe states
"We are very encouraged by results of the previous study. Tectin™
is very promising particularly for cancer patients presented with
severe pain or pain not responding to other drugs. The Phase IIb/III
pivotal study might be the most important clinical study on cancer
pain conducted in Canada and the research team at the Jewish General,
one of Canada 's most active cancer research centres, is proud to
be initiating them."
In cancer particularly, there
is need of pain medications that are effective, easily administered,
and non-addictive. Animal studies showed that Tectin™ is much more
potent than standard opioids, non-addictive, and furthermore the
product can be given subcutaneously, thus preventing complications
with patients suffering from nausea or other conditions that may
interfere with the oral administration of an analgesic.
Wex originally used the drug
compound for the treatment of drug withdrawal but it was noted that
the main factor in its ability to relief or eliminate withdrawal
symptoms was its ability to reduce pain. Thus, Wex pursued testing
of Tectin™ for refractory cancer relief in cancer patients. With
these encouraging results, Tectin™ will also be investigated for
clinical use in patients suffering from non-cancer chronic pain.
The Pivotal trial of Tectin™
in cancer pain is expected to continue for the next 12 months, with
interim results expected in 2005.
International Wex Technologies
Inc., a publicly listed neuro-bioscience company (WXI), is focused
on the development and commercialization of innovative drug products,
primarily for pain management. The Company's lead compound, Tetrodotoxin,
is a sodium channel blocker and is the platform for the Company's
development of a portfolio of proprietary products in the field
of analgesia, drug addiction withdrawal treatment, and local anaesthesia.
For additional information
on our products visit us at http://www.wextech.ca or call Don Evans
or Gordon Stanley, Corporate Communications at 604-683-8880, or
at 1-800-722-7549.
Per: Donna Shum, Corporate
Secretary
The Toronto Stock
Exchange has not reviewed and does not accept responsibility for
the adequacy or accuracy of the content of this News Release.
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