Toronto, Ontario – December 29, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that the University Health Network Review Ethics Board (“UHN REB”) has approved the Clinical Study for evaluation of the Company’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 endpoints of safety and tolerability, with an exploratory end point of efficacy, in a patient population who meets the inclusion / exclusion criteria of the study as evaluated by UHN’s uro-oncology department.
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 Photo Dynamic Therapy (“PDT”) 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 (“CTA”) approval have been received, pending Investigational Testing Application (“ITA”) 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 CEO, stated that, “The Company has focused its resources on the successful completion of four major strategic objectives prior to yearend; 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 4 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.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC) 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.
Additional information is available at theralase.com and sedar.com .
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.
For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com