To Repeat The following is the reason for all the excitement
Toronto, Ontario – January 31, 2019, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQB: 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 reports that patient five, enrolled and treated in the recently completed Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence or presence of disease at the 360 day clinical and cystoscopy assessment.
The Study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy, primarily at 90 days and secondarily at 180 days post treatment.
The Study was successfully completed with patient five and six demonstrating achievement of the primary, secondary and exploratory endpoints.
Patient five has demonstrated no tumour recurrence or presence of disease at the 90, 180, 270 and now 360 days post treatment clinical and cystoscopy assessment, marking a new achievement for the Company.
Patient five and six were enrolled and treated in the Study at the Therapeutic Dose (0.70 mg/cm2). Theralase’s Anti-Cancer Treatment involved the intravesical 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 was 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, comprising a Laser Emitter used to emit laser light and a proprietary Dosimetry System used to detect laser light, were then used to activate TLD-1433 resident in the NMIBC tumours.
Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated, “Today, we received additional evidence that even a single treatment with Theralase’s Photo Dynamic Therapy (“PDT”) is able to lead to a Complete Response (“CR”) at 360 days post treatment for patients presenting with Bacillus Calmete Gurin (“BCG”)-Unresponsive NMIBC. This provides further support of the enormous opportunity that awaits Theralase in the treatment of NMIBC. For NMIBC, a CR is defined by the FDA as the definitive endpoint for single-arm intravesical studies of patients who present with BCG-Unresponsive Carcinoma In-Situ (“CIS”) disease, with or without resected papillary tumours. In the Health Canada approved Phase II NMIBC clinical study, the Company is providing two treatment procedures (therapeutic procedure at Day 0 and maintenance procedure at Day 180). The latest data on patient five is extremely encouraging, in that it demonstrates after only one anti-cancer treatment procedure, CR at 90, 180, 270 and now 360 days post-treatment is possible. If the efficacy results obtained to date are able to be replicated, demonstrating a CR at 360 days post-treatment, in a larger patient population, via a well-designed Phase II NMIBC clinical study, then the Theralase Anti- Cancer Technology has the potential to be the next gold standard in the treatment of NMIBC.
highly encouraged by this recent data demonstrating that BCG-Unresponsive NMIBC patients, who
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refused or were ineligible to undergo a radical cystectomy (bladder removal surgery) have remained
cancer free at 270 and now up to 360 days post