Theralase Demonstrates Anti-Cancer Technology Prevents Recurrence of Bladder Cancer at 180 Days Post-Treatment
Patient Five Demonstrates No Clinical Evidence of NMIBC at 180 Day Cystoscopy Analysis
Toronto, Ontario – July 16, 2018, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers has provided an update on patient five, enrolled and treated in the recently completed Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”).
The Study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability with a secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and an exploratory endpoint of efficacy.
The exploratory outcome endpoint is defined as Recurrence-Free Survival (“RFS”), which is the interval from the day of the treatment to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumour growth (i.e. any biopsy-confirmed new or recurrent tumour), evaluated primarily at ninety (90) days for the last three patients treated at the Therapeutic Dose (0.70 mg/cm2) and secondarily one hundred and eighty (180) days post treatment.
As previously reported, the Company, in conjunction with its clinical partner, have optimized the clinical treatment procedure of the Study, commencing with patient number five.
The treatment was well tolerated by the patient, who demonstrated no tumour recurrence or presence of disease at the 180 day clinical and cystoscopy assessment.
The patient has met Study endpoints demonstrating achievement of the primary, secondary and exploratory endpoints at 180 days post treatment and marks a new achievement for the Company.
Theralase’s Anti-Cancer Treatment involves the instillation of a water-based solution of Theralase’s lead anti-cancer PDC, TLD-1433, via a catheter inserted through the urethra into the bladder of the patient, to allow the PDC to be preferentially absorbed by NMIBC tumours. The bladder is then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, known as a Laser Emitter emits laser light to activate TLD-1433, while a Dosimetry Cage detects the emitted laser light, used for patient safety and efficacy. Both devices are inserted through the cystoscope, with a sole purpose of activating the absorbed PDC to destroy the NMIBC tumours.
Arkady Mandel, M.D., Ph.D., D. Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated, "This is just another example of the power of Theralase’s Anti-Cancer Technology and the enormous opportunity that awaits this young biopharma company. If these same results are confirmed in a well-designed Phase II NMIBC clinical study, then the Theralase Anti-Cancer Technology may very well be the next gold standard in the treatment of NMIBC. The Anti-Cancer Technology is also multi-pronged, as it can be adapted in the treatment of a wide range of cancerous targets. The "big picture" here is that the Theralase Anti-Cancer Technology is not restricted to any particular type of cancer; therefore, pending successful regulatory approval for the treatment of NMIBC, Theralase intends to bring this technology on board in the treatment of numerous cancer targets.”
