Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) reported on 1/30/19 that patient six, enrolled and treated in the recently completed Phase Ib Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study"), has demonstrated no tumor recurrence or presence of disease at the 270 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 and six have demonstrated no tumor recurrence or presence of disease at the 90, 180 and now 270 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 tumors. 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 tumors.
The Phase II NMIBC Clinical Study, entitled, "A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer or Patients Who are Intolerant to BCG Therapy" will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC patients in approximately 20 clinical sites located in Canada, the US and internationally, with a primary endpoint of efficacy and a secondary endpoint of safety.