Toronto, Ontario - Theralase Technologies Inc. (“Theralase” or the “Company”) ($TLT:CA) ($TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has submitted its anti-cancer technology to the Research Ethics Board (“REB”) of Princess Margaret Cancer Center, University Health Network (“UHN”) for approval.
The REB is responsible for reviewing the anti-cancer technology and assessing it from a clinical viewpoint. The anti-cancer technology consists of the Company’s lead Photo Dynamic Compound (“PDC”), TLD-1433, which is light activated by the proprietary Theralase TLC-3200 Oncology Laser System for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”). The REB, pending review, will authorize the UHN clinical team to commence enrolling patients, inflicted with NMIBC, into a Phase Ib clinical trial to study the effects of the technology as determined by the primary outcome measures of safety and tolerability, and as an exploratory endpoint, efficacy.
Pending approval of the following applications, UHN will commence enrolling patients:
- Health Canada Clinical Trial Application (“CTA”) (Submission Complete);
- Health Canada Investigational Testing Authorization (“ITA”) (Submission Complete);
- UHN REB (Submission Complete).
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 the University Health Network stated that, “The role of the UHN REB is to clinically review all the Theralase documentation regarding the proposed Photo Dynamic Therapy (“PDT”) treatment of patients inflicted with NMIBC who meet the inclusion and exclusion criteria of the study. Subject to REB and Health Canada CTA and ITA approval, 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 CEO, Theralase stated, “Theralase has now completed all submissions required by Health Canada and UHN in order to evaluate and approve its proposed PDT treatment of NMIBC. Pending approval, Theralase will now embark on one of the most important milestones of its existence, proving the safety, tolerability and efficacy of its cutting-edge anti-cancer technology in the destruction of NMIBC.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) ($TLT:CA) ($TLTFF) in its Therapeutic Laser Technology Division designs, manufactures and markets patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy Division researches and develops specially designed molecules called Photo Dynamic Compounds, which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
Theralase Technologies Inc. was recognized as a TSX Venture 50® company in 2015. TSX Venture 50 is a trademark of TSX Inc. and is used under license.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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