WEX files clinical trial application with Health Canada for Tectin

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WEX Pharmaceuticals Inc. files a clinical trial application with the Biologics and Genetics Therapies Directorate (BGTD) of Health Canada for Tectin(TM), the lead candidate in the company's Tetrodotoxin (TTX) technology platform. Upon clearance from Health Canada, WEX will initiate the clinical trial of Tectin for the treatment of moderate to severe inadequately controlled cancer-related pain.

The trial will be multi-centre, randomized, double-blind, placebo-controlled with the primary objective of comparing the efficacy and safety of subcutaneous Tectin with placebo in reducing pain outcome and improving the quality of life in patients with cancer-related pain.

In this trial, a composite endpoint will be used to identify responders to study treatment, i.e., reduction in pain, or decrease in analgesic consumption and improvement in quality of life. Since pain assessment is subjective and it has been assumed that relief of pain is accompanied by improvement in quality of life, a composite endpoint is the most efficient method of determining a true responder. This approach also conforms to the current guidelines for chronic pain trials.