heralase’s TLD-1433 study receives UHN ethics board OK

2015-12-29 07:06 ET – News Release

Mr. Roger Dumoulin-White reports

UNIVERSITY HEALTH NETWORK REVIEW ETHICS BOARD APPROVES CLINICAL STUDY FOR ANTI-CANCER DRUG

The University Health Network review ethics board has approved the clinical study for evaluation of Theralase Technologies Inc.’s next-generation anti-cancer drug, TLD-1433, in a phase Ib clinical trial for patients inflicted with non-muscle invasive bladder cancer (NMIBC). The phase Ib NMIBC clinical trial will evaluate the anti-cancer technology for the primary end points of safety and tolerability, with an exploratory end point of efficacy, in a patient population which meets the inclusion/exclusion criteria of the study as evaluated by UHN’s uro-oncology department.

Dr. Michael Jewett, MD, a professor of surgery in the division of urology at the University of Toronto, a member of the department of surgical oncology at Princess Margaret Cancer Centre and of the division of urology at University Health Network, stated that: “The role of the UHN REB is to clinically review all the documentation regarding the proposed photodynamic therapy treatment of patients inflicted with NMIBC, who meet the inclusion and exclusion criteria of the study. Now that UHN REB and Health Canada clinical trial application approval have been received, pending investigational testing application approval by Health Canada of the laser system used to activate the anti-cancer drug, UHN will commence enrolling and immediately treating patients inflicted with NMIBC according to the clinical protocol and investigator’s brochure supplied by Theralase.”

Roger Dumoulin-White, president and chief executive officer, stated that: “The company has focused its resources on the successful completion of four major strategic objectives prior to year-end; specifically, Health Canada approval of the next-generation TLC-2000 therapeutic medical laser system (completed); FDA approval of the TLC-2000 (completed); Health Canada CTA approval (completed) and Health Canada ITA approval (pending); UHN REB approval (completed). Theralase has now completed 3.5 of these four strategic objectives and will complete the final objective in due course to allow the phase Ib clinical study to commence in early 2016. The UHN REB approval represents the second to final step, which will allow the commencement of a very important clinical study in Theralase’s history, which if successful will prove the safety, tolerability and hopefully the efficacy of the company’s next-generation anti-cancer technology in the treatment of NMIBC.”

We seek Safe Harbor.