Health Canada Grants Theralase ITA Approval
Toronto, Ontario – October 20, 2016, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that Health Canada has granted the Company Investigational Testing Authorization (“ITA”) approval to use its patent pending TLC-3200 Photo Dynamic Therapy (“PDT”) Laser System and TLC-3400 Dosimetry Fibre Optic Cage (“DFOC”) technology, in conjunction with its Clinical Trial Application (“CTA”) approved lead PDC, TLD-1433, to commence a Phase Ib clinical trial for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”).
The TLC-3200 PDT Laser System delivers green laser light, at a wavelength of 525 nanometers (“nm”), while the DFOC technology precisely monitors the laser light to provide a uniform distribution of the laser light energy, in the correct dosage, to the bladder wall.
Theralase, possessing both CTA and ITA approval, plans to immediately commence a Phase Ib clinical study for the treatment of NMIBC.
The patient population will be comprised of subjects with high risk, Ta/T1 or TIS NMIBC that are intolerant or refractory to Bacillus Calmette-Guérin (“BCG”) and who are not candidates or refuse radical cystectomy.
The primary objective of this study is to evaluate the safety of PDT employing TLD-1433 and controlled laser light distribution via the TLC-3200 and TLC-3400 DFOC System.
The secondary objective of this study is to evaluate the pharmacokinetics (“PK”) (the branch of pharmacology concerned with the movement of drugs within the body) of TLD-1433.
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase is very proud of the hard work delivered by the team that resulted in Health Canada’s decision to grant the Company ITA approval of its TLC-3200 and TLC-3400 technologies. I join the entire team in stating that we look forward to commencing a Phase Ib clinical study for NMIBC and demonstrating to the world what this technology is truly capable of.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes 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 (“PDT”) Division researches and develops specially designed molecules called Photo
Dynamic Compounds (“PDCs”), which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
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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