Theralase Provides Update on Bladder Cancer Study

About this update from Theralase Technologies Inc.

[{"type":"text","content":"Theralase Provides Update on Bladder Cancer StudyTORONTO, ON / ACCESSWIRE / September 24, 2020 / Theralase® Technologies Inc. (\"Theralase\" or \"Company\") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (\"PDC\") and associated drug formulations, announced today that McGill University Health Centre (\"MUHC\") has re-commenced new patient enrollment and treatment in the Company's Phase II Non-Muscle Invasive Bladder Cancer (\"NMIBC\") clinical study (\"Study II\").Study II has enrolled and treated 12 patients to date. Out of the 7 patients that are eligible to receive the second treatment, 5 have been treated and 2 are pending. 2 out of the last 5 patients treated for the second time have been treated with the optimized Study II treatment, which will also be the case for the 2 patients that are pending their second treatment.Efficacy to date at the 90 day assessment includes:3 out of 12 patients (25%) have demonstrated a Complete Response (\"CR\") (Negative cystoscopy and negative (including atypical) urine cytology3 out of 12 patients (25%) have demonstrated a Partial Response (\"PR\") (2 patients with negative cystoscopy and positive urine cytology and 1 patient with positive cystoscopy and negative urine cytology), with 2 of these patients having received second treatment.The Company is in advanced discussions with the US based Trial Management Organization to potentially launch 5 clinical study sites in the United States in 4Q2020, subject to the US economy successfully recovering from the COVID-19 pandemic. If launched in 4Q2020, the Company would expect Study II patient enrollment and treatment in 1Q2021.Theralase® recently submitted an application to the Food and Drug Administration (\"FDA\") for Fast Track Approval (\"FTA\"). The application was denied by the FDA, citing certain improvements required to the application. Theralase has revised the FTA application and has resubmitted it to the FDA. Subject to successful FDA approval of the FTA application, Theralase should be in a position to receive FDA FTA approval in 4Q2020.Shawn Shirazi, Ph.D., Chief Executive Officer of Theralase stated, \"Theralase is pleased that all four Canadian clinical study sites are open for new patient enrollment and we are gearing ...

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