Patient Five Cancer-Free Eighteen Months After Single Anti-Cancer Treatment
TORONTO, ON / ACCESSWIRE / July 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 Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 540 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 at 90 and 180 days, when treated with the Therapeutic Dose.
Patient five has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 90, 180, 270, 360 and now 540 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 toemit laser light and a proprietary Dosimetry System used todetect laser light, were then used to activate TLD-1433 resident in the NMIBC tumours.
Shawn Shirazi, Ph.D., Chief Executive Officer - Drug Division 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 duration of Complete Response (“CR”) at 540 days post treatment for patients presenting with Bacillus Calmette Guérin (“BCG”)-Unresponsive NMIBC. This provides further support of the enormous opportunity that awaits Theralase in the treatment of NMIBC. If we are able to obtain similar efficacy results in CR rate and Duration in a larger patient population, through the Phase II NMIBC clinical study, then the Theralase Anti-Cancer Technology has the potential to be the next standard in the treatment of NMIBC. We are extremely excited and encouraged by this recent data demonstrating that BCG-Unresponsive NMIBC patients, who refused or were ineligible to undergo a radical cystectomy (surgical removal of bladder) have remained cancer free at 360 and now up to 540 days post treatment. Theralase’s TLD-1433 Photo Dynamic Therapy (“PDT”) may provide sustainable and comprehensive benefit to people diagnosed with NMIBC and the Company will be providing updates on the Phase II NMIBC clinical study as patients are enrolled and treated. The TheralaseAnti-Cancer Technology is also multi-faceted, in that the technology is able to be adapted to the treatment of additional cancer indications if successfully validated in independent clinical studies. The Company plans to investigate the commencement of an additional Phase Ib clinical study for a new cancer indication after the Phase II clinical study is well underway.”
About Theralase Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers.
Additional information is available at www.theralase.com and www.sedar.com. |
