Toronto, Ontario – April 9, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF: OTC Pink®) announced today that it has successfully manufactured the first pre-commercial batch of its lead anti-cancer Photo Dynamic Compound (“PDC”), TLD-1433, one of a new generation of unique light-activated anti-cancer compounds, specifically developed for the treatment of cancer.
Drugs intended for in human clinical applications, such as TLD-1433, must be manufactured in accordance with Good Manufacturing Practices (“GMP”) standards. To achieve GMP standards, the normal process is a “scale-up” in production from a small quantity to validate the manufacturing process to larger pre-commercial quantities demonstrating manufacturing optimization and finally commercial quantities, produced under strict GMP standards, suitable for human use.
Theralase has now successfully completed a major milestone in its anti-cancer program by having TLD-1433 successfully manufactured to pre-commercial quantities, allowing this quantity to be used in toxicology analyses, a key requirement for Health Canada Clinical Trial Application (“CTA”) approval. Theralase intends to have a second pre-commercial batch manufactured in 2Q2015, which will be used to further optimize the manufacturing process and will be suitable for research into additional cancer indications for TLD-1433. Production of a commercial GMP quantity suitable for human clinical applications will be completed in 2Q2015.
The commercial GMP batch will provide enough anti-cancer drug to support Theralase’s entire clinical program through to commercialization for advanced Photo Dynamic Therapy (“PDT”) in the treatment of patients with Non-Muscle-Invasive Bladder Cancer (“NMIBC”). The Phase Ib clinical trial is expected to receive Health Canada CTA approval in 3Q2015 and commence patient enrollment in 4Q2015.
Theralase is in development of an advanced platform of anti-cancer PDT technologies for the treatment of numerous cancers, commencing with the treatment of NMIBC.
Dr. Arkady Mandel, Chief Scientific Officer stated that, “We have been successful in establishing a robust scale-up manufacturing process for our anti-cancer drugs. We have managed to transfer the manufacturing process knowledge of TLD-1433 from the laboratory to pre-commercial production levels, able to fulfill requirements to initiate the toxicology program. It has been demonstrated repeatedly that our lead PDC is effective in the treatment of cancer in animal models and we look forward to effectively treating cancer in humans in a clinical setting. The successful production of the first pre-commercial batch of our lead PDC, TLD-1433, represents one of the most important milestones to date in the history of Theralase’s anti-cancer program, leading to commercial production of advanced biopharmaceuticals for the treatment of cancer.”
Roger Dumoulin-White, President and CEO stated, “Theralase is extremely well positioned to commence our Health Canada Phase Ib human clinical studies in bladder cancer in 4Q2015, now that we have successfully assembled a top notch team consisting of: cutting-edge research scientists, world renowned uro-oncologists, world-class manufacturing, an internationally recognized toxicology lab and a strong clinical research organization. 2015 will be a landmark year for the Company, as we execute on our strategic initiatives.”
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About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC Pink®) 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 the 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.