OMG...We got FAST TRACK APPROVAL>>> :) TORONTO, ON / ACCESSWIRE / November 23, 2020 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that the U.S. Food and Drug Administration ("FDA") has granted Theralase® Fast Track Designation ("FTD") for its Phase II Bacillus Calmete Gurin ("BCG")-Unresponsive Non Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In Situ ("CIS") clinical study ("Study II").
As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase's development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system ("TLC-3200"), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.
Michael Jewett MD, FRCSC, FACS, Inaugural Farquharson Clinical Research Chair in Oncology, Departments of Surgery (Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network ("UHN"), stated "By awarding Fast Track Designation to the photosensitizer drug TLD-1433 activated by the laser TLC-3200, currently being assessed in a Phase II clinical study for the treatment of NMIBC, the FDA has recognized Theralase®'s potential to meaningfully improve patient outcomes for this life-threatening disease. This is a significant accomplishment for the Company. This latest milestone complements the clinical development strategy to provide urologists, uro-oncologists and patients with the tools to combat BCG-Unresponsive NMIBC, safely and effectively."