VANCOUVER, BRITISH COLUMBIA--(Marketwire - September 27, 2010) - WEX Pharmaceuticals Inc. (“WEX” or the “Company”) (TSX: WXI) announced today that the data monitoring committee (“DMC”) has undertaken its scheduled interim analysis of the Company’s ongoing TEC-006 clinical trial of Tetrodotoxin (TTX). Based on a review of the safety and efficacy assessments for 60 evaluable patients, the DMC has verbally informed the Company that it saw no safety concerns to stop or modify the trial and that the trial was unlikely to demonstrate a clinically meaningful treatment-effect difference between TTX and placebo based on the primary composite efficacy endpoint. However, the DMC advised that with an increase in sample size to 150 evaluable patients, the trial may demonstrate a difference in efficacy based on one or more components of the composite endpoint. The trial was originally planned to enroll 120 evaluable patients.
The DMC is a group of three independent experts appointed by the Company to review data from the clinical trial and make a recommendation to the Company on continuing the trial as planned in the protocol, expanding the trial to enroll additional patients, or terminating the trial for either safety or efficacy reasons. To conduct this analysis, the DMC has been given access to the interim results of the trial. The Company, Trial Steering Committee and Trial Investigators remain blinded to the data until the close of the trial.
WEX plans to discuss the primary and secondary efficacy endpoints and expanding the trial with Health Canada in October. In the meantime, the trial will continue to enroll patients until a decision is taken on how to modify the trial following the meeting with Health Canada.
About the TEC-006 Clinical Trial
TEC-006 is a Phase III multicentre, randomized, double-blind and placebo-controlled trial comparing the efficacy and safety of TTX to placebo in patients with moderate to severe inadequately controlled cancer-related pain. Enrolment and dosing of the first patient in the TEC-006 trial occurred in April 2008. All patients participating in the TEC-006 trial, both those receiving drug and those receiving placebo, are given the opportunity to participate in an open-label clinical trial (TEC-006OL) where all patients receive TTX.
About TTX
Tetrodotoxin (TTX) is a highly selective sodium channel blocker derived from the puffer fish. Sodium channels are found on nerves and are involved in the transmission of nerve impulses. Tetrodotoxin targets a subset of sodium channels found on nerves which conduct pain impulses. There are changes to this subset of sodium channels in chronic pain conditions. Tetrodotoxin is extremely potent, and much lower dosages are needed to produce an analgesic effect than with other drugs.
About WEX Pharmaceuticals Inc.
WEX Pharmaceuticals Inc. is dedicated to the discovery, development, manufacture and commercialization of innovative drug products to treat pain. The Company’s principal business strategy is to derive drugs from naturally occurring toxins and develop proprietary products for the global market.
Forward Looking Statements and Information
Certain statements herein may contain forward-looking statements and forward-looking information within the meaning of applicable securities laws. Forward-looking statements or information appear in a number of places and can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate” or “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements and information are subject to such risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. See our annual information form and our quarterly and annual management’s discussion and analysis for additional information on risks and uncertainties relating to the forward-looking statements and information. There can be no assurance that forward-looking statements or information referenced herein will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Also, many of the factors are beyond the control of the Company. Accordingly, readers should not place undue reliance on forward-looking statements or information. All forward-looking statements and information made herein, are qualified by this cautionary statement.
Contacts:
WEX Pharmaceuticals Inc.
Dr. Bin Huang
President & CEO
(604) 683-8880 or Toll Free: 1-800-722-7549
(604) 683-8868 (FAX)
wex@wexpharma.com
www.wexpharma.com