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News Release
Tectin™ Development
Update
Date: November 26 , 2003
TSX Venture Exchange
Trading Symbol: WXI
http://www.wextech.ca
E-mail: wex@wextech.ca
International Wex Technologies
Inc. ("Wex" or the "Company") is pleased to provide an update on
its progress with the clinical development of Tectin™, the Company's
product for the management of pain.
Tectin™ for the
management of cancer related pain
Wex is pleased to announce
that the Company has had a meeting with Health Canada and, based
on that meeting, will be filing for a pivotal Phase IIb/III clinical
trial shortly. At the meeting with Health Canada, Wex presented
the interim analysis of the Phase IIa trial, along with a Phase
IIb/III protocol outline. The Phase IIb/III protocol which will
be filed includes input from Health Canada and, in addition, will
differ from the Phase IIa trial in that intramuscular injections
will be replaced by subcutaneous injections which would be better
tolerated in the target patient population and, according to a recent
clinical study in healthy volunteers, are as effective as the intramuscular
injections.
The interim results of
the Phase IIa trial were presented earlier in November by Dr Edward
Sellers, Senior Medical Consultant to Wex, at the 18th Annual Meeting
of the International Society for Biological Therapy of Cancer in
Bethesda, Maryland. The trial was a multicenter, open label, dose
escalation study to evaluate the safety and analgesic effect of
Tectin™ in patients with a variety of cancer pains. All patients
had severe or worse pain, caused by their cancer or as a consequence
of cancer treatment, and had failed currently established analgesic
strategies. All enrolled patients completed the trial. Most patients
(68%) achieved a clinically meaningful analgesic response based
on the primary endpoint of 33% or more reduction in pain intensity.
No serious adverse events were reported.
Tectin™ for the
management of non-cancer related pain
Wex is also pleased to
announce that following the filing of the Clinical Trial Application
(CTA) on November 12, 2003, it has received an 'Acknowledgement
of Receipt or Screening Acceptance Letter' for "An Open-Label Study
Protocol to Assess the Safety and Efficacy of Tectin™ for Patients
with Severe, Intractable, Non-malignant Chronic Pain" from Health
Canada. This means that the dossier has been accepted for review,
and, barring complications, approval of this study is expected in
30 days.
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,
a sodium channel blocker, 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, view the Company website at http://www.wextech.ca
or call Gordon Stanley at 604-683-8880 or 1-800-722-7549.
Per: Donna Shum, Corporate
Secretary
The news release contains forward-looking
statements that involve known and unknown risks and uncertainties,
including discussions of preliminary Phase IIa clinical trial results.
Final results could be different depending upon the outcome of further
studies, interpretations, and additional clinical data. Forward-looking
statements are based on current expectations; we assume no obligation
to update such information to reflect later developments. The TSX
Venture Exchange has not reviewed and does not accept responsibility
for the adequacy or accuracy of the contents of this news release.
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