Theralase Provides Update on ITA Application to Health Canada
Toronto, Ontario – October 5, 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 an update on the status of an Investigational Testing Authorization (“ITA”) filed with Health Canada for 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, in 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 filed an ITA application with Health Canada on July 29, 2016. On September 16, 2016, Theralase received a formal response, which consisted of a series of 6 questions from Health Canada seeking additional information on the ITA application.
Theralase compiled a comprehensive written response on September 23, 2016 and it was received by Health Canada on September 26, 2016.
Health Canada has indicated that they require approximately 45 days to review the written response and as a result Theralase is not expecting a formal response from Health Canada until mid November 2016.
Theralase expects final ITA approval at this time, but Health Canada possesses the ability to ask additional questions, either as a clarification request, resulting in an additional 10 day review or request new information resulting in an additional 45 day review.
Pending Health Canada approval of the ITA, Theralase will immediately commence enrollment of patients into a Phase Ib clinical study in the treatment of NMIBC. The primary outcome measures of the Phase Ib clinical study will be safety and tolerability, with a secondary outcome measure of pharmacokinetics (where the drug accumulates in tissue and how it exits the body) and an exploratory outcome measure of efficacy.
Roger Dumoulin-White, President and CEO of Theralase stated that, “It has taken significant time and resources to complete the required testing by Health Canada and to adequately address their questions, in order to be in a position to receive final ITA approval of the TLC-3200 PDT Laser System and TLC-3400 DFOC technology. Theralase is confident that the detailed written response that it has supplied Health Canada will result in a final ITA approval in mid to late November 2016, allowing commencement of a Phase Ib clinical trial for NMIBC. We look forward to a favourable and timely review by Health Canada to allow the Company the ability to commence the Phase Ib clinical study for NMIBC.”
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.
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