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Theralase Commences Phase II NMIBC Clinical Study
TORONTO, ON / ACCESSWIRE / April 25, 2019 / Theralase ® Technologies Inc. (" Theralase...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Theralase Commences Phase II NMIBC Clinical StudyTORONTO, ON / ACCESSWIRE / April 25, 2019 / Theralase® Technologies Inc. (\"Theralase\" or the \"Company\") (TLT:TSXV) (TLTFF:OTCQB), a clinical stage pharmaceutical company dedicated to the research and development of light-activated Photo Dynamic Compounds (\"PDC\") and their associated drug formulations intended to safely and effectively destroy various cancers, announced today that the University Health Network Research Ethics Board (\"UHN-REB\") has approved the commencement of a Phase II clinical study to evaluate Theralase's Anti-Cancer Treatment (\"ACT\") titled, \"Patients with Non-Muscle Invasive Bladder Cancer (\"NMIBC\"), who present with Carcinoma In-Situ (\"CIS\"), who are considered Bacillus Calmette Guérin (\"BCG\") - Unresponsive or are intolerant to BCG Therapy (\"ACT-NMIBC\")\".The ACT-NMIBC study has been designed in compliance with FDA industry guidelines issued February, 2018 for BCG-unresponsive NMIBC. The study will utilize the Therapeutic Dose (0.70 mg/cm) of TLD-1433 and will focus on the treatment of approximately 100 to 125 BCG-unresponsive NMIBC patients, with CIS, in approximately 20 clinical study sites in Canada, the US and internationally, with a primary endpoint of efficacy and a secondary endpoint of safety.Study sites will be launched first in Canada, followed by the US, subject to Food and Drug Administration approval, and then internationally, subject to international regulatory approval.The primary endpoint of the Study: Efficacy – Evaluated by Complete Response (\"CR\") in patients with CIS with or without resected papillary disease at 90 days post-treatment with a duration of CR evaluated at 360 days post-treatment.Patient CR is defined as: Negative cystoscopy and negative (including atypical) urine cytology Positive cystoscopy with biopsy-proven benign or low-grade NMIBC or Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative The secondary endpoint of the Study is:Safety – Evaluated by the incidence and severity of Adverse Events (\"AEs\") Grade 4 or higher that do not resolve within 360 days post-treatment; whereby: Grade 1 = MildGrade 2 = ModerateGrade 3 = SevereGrade 4 = Life-threatening or disabling Grade 5 = Death ...