TORONTO, ON / ACCESSWIRE / September 15, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX Venture: TLT) (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."
