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 detailed information on how the TLC-3000B Laser System will be used to activate the Company’s lead light activated Photo Dynamic Compound (“PDC”), TLD-1433 in the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”).
Pending Health Canada approval of a Clinical Trial Application (“CTA”) and Princess Margaret Cancer Center, University Health Network (“UHN”) Review Ethics Board (“REB”) approval, expected in late 4Q2015, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at UHN to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy.
Completion of information pertaining to the laser technology used to activate TLD-1433 marks the fourth and final major milestone for the Company required to complete its submission of a REB application to UHN and a CTA application to Health Canada.
Key components required to submit a REB application to UHN and a CTA to Health Canada for a new drug / device combination include:
1) GMP manufacture of the drug (Complete);
2) Good Laboratory Practice toxicology analysis of the drug (Complete);
3) Completion of the Clinical Protocol and Investigator’s Brochure (Complete);
4) Completion of detailed information regarding the device used to activate the drug (Complete).
Information regarding the TLC-3000B Laser System includes: safety information, medical device description, specifications, risk analyses, standard operating procedures and recommended maintenance procedures that a uro-oncologist would follow to administer a Photo Dynamic Therapy (“PDT”) treatment using light activated TLD-1433 to a patient inflicted with NMIBC.
Roger Dumoulin-White, President and CEO of Theralase stated that, “The completion of the fourth and final component required to submit a REB to UHN and a CTA to Health Canada marks a new milestone in Theralase’s pursuit of the destruction of NMIBC. Pending approval of these two submissions, Theralase will commence enrolling and treating patients in a Phase Ib clinical study for NMIBC at UHN.”
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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