Toronto, Ontario – April 22, 2016, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on commercialization of medical devices to eliminate pain and development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that it has reached a milestone, demonstrating 6 month accelerated stability and 9 month long term stability of it lead anti-cancer PDC, TLD-1433.
Stability studies are an essential component of pharmaceutical development, allowing evaluation of a drug’s stability under the influence of a variety of environmental factors such as: temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.
Demonstrating accelerated and long term stability of a drug to be used in human clinical testing is essential to prove that the potency and/or efficacy of the drug is not affected during prolonged shelf life.
Under accelerated and long term stability storage conditions, the drug is evaluated by High Performance Liquid Chromatography to separate, identify and quantify each chemical component to a very high degree of resolution to assess if any change occurs in the chemical composition over time.
Long term stability is completed over three years, with reporting at 0, 3, 6, 9, 12, 18, 24 and 36 months. Accelerated stability is completed over six months, with reporting at 0, 3 and 6 months.
TLD-1433 has now demonstrated stability at 6 months under accelerated conditions and 9 months under long term stability conditions, satisfying Health Canada guidelines, to allow use in treating patients in a clinical study.
The Company is currently pursuing an Investigational Testing Authorization (“ITA”) of its proprietary laser system to activate the PDCs for the indication of Non-Muscle Invasive Bladder Cancer (“NMIBC”).
Theralase is focused on commencing and successfully completing a Phase Ib clinical trial for patients afflicted with NMIBC utilizing its novel, next generation light-activated, anti-cancer drug, TLD-1433 for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement of drug within tissue) and an exploratory endpoint of efficacy.
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology (“TLT”) 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 (“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.
Additional information is available at www.theralase.com and www.sedar.com .
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