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 completed manufacture of a second batch of its lead Photo Dynamic Compound (“PDC”), TLD-1433 in compliance with Good Manufacturing Practice (“GMP”) standards. This milestone demonstrates Theralase’s ability to consistently and reliably manufacture its lead light activated drug in the same purity and yield as the original GMP batch.
Consistency in manufacture of TLD-1433 is essential to prove to regulatory agencies that a drug intended for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”) can be reliably produced to GMP quality standards.
Theralase plans to evaluate TLD-1433 in a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy commencing in late 4Q2015.
Theralase has completed and submitted all required documentation in 3Q2015 to Health Canada and University Health Network to evaluate the light activated drug for the lead indication of NMIBC.
Roger Dumoulin-White, President and CEO, Theralase stated that, “Theralase continues to execute on its strategic initiative to advance its anti-cancer technology to commence destroying NMIBC this year. Theralase has now demonstrated control of its manufacturing process to produce high grade TLD-1433 in large quantities. Pending successful completion of a Phase Ib and Phase II clinical study in NMIBC, Theralase now possesses the ability to rapidly ramp-up production of TLD-1433 in commercial quantities to supply oncology institutions, who treat this deadly disease.”
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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Source: Theralase Technologies Inc. (TSX Venture:TLT, OTC Pink:TLTFF) http://theralase.com/
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