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Theralase PDT Technology Used to Treat Third Patient for Bladder Cancer
Toronto, Ontario – April 20, 2017, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TLT: TSXV) (TLTFF: OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that the third patient was treated on April 18, 2017 for Non-Muscle Invasive Bladder (“NMIBC”) cancer using its novel Photo Dynamic Therapy (“PDT”) technology.
The PDT treatment procedure involves the instillation of a water based solution of Theralase’s lead anti-cancer PDC, TLD-1433, through the urethra into the bladder of the patient, to allow localization of the PDC to the NMIBC. The bladder is then drained of the solution, flushed with sterile water to remove excess solution and refilled with sterile water via a cystoscope. At this point, a fibre optic assembly, known as a Dosimetry Fibre Optic Cage (“DFOC”) with the ability to both emit and detect laser light, is inserted through the cystoscope, to activate the PDC.
The Phase Ib NMIBC clinical study (“Study”) will be used to evaluate TLD-1433 for the primary endpoints of safety and tolerability, a secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and an exploratory endpoint of efficacy.
The Study has been designed to treat 3 patients at a lower dose of the PDC and to monitor the patients for 30 days, according to the endpoint criteria above. If deemed successful, an additional 6 patients will be enrolled into the Study to be treated at a higher dose of the PDC and monitored for 180 days, according to the endpoint criteria.
An independent, Theralase-appointed, Data and Safety Monitoring Board (“DSMB”) will review the data collected on the first three patients, at 30 days post treatment. By the end of May 2017, the DSMB will provide their recommendation to Theralase on whether to enroll 6 additional patients for PDT dose escalation, based on achievement of the primary and secondary endpoints.
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase has now completed PDT treatment of the first 3 patients in the Study and we look forward to successfully reporting out on our performance to the primary and secondary endpoints of the first three patients by the end of May 2017.”
