Theralase Enrolls First Patient into Phase II Non-Muscle Invasive Bladder Cancer Clinical Study

About this update from Theralase Technologies Inc.

[{"type":"text","content":"Theralase Enrolls First Patient into Phase II Non-Muscle Invasive Bladder Cancer Clinical StudyTORONTO, ON / ACCESSWIRE / July 29, 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 PhotoDynamic Compounds (“PDC”) and their associated drug formulations, intended to safely and effectively destroy various cancers, announced today that the first patient has been enrolled into its Phase II clinical study 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 (“Phase II”)” at University Health Network (“UHN”) in Toronto.Phase II has been designed in compliance with FDA industry guidelines for BCG-unresponsive NMIBC (issued: February 2018) and defined by the FDA in a Pre-Investigational New Drug (“IND”) conference call in late June 2019. The study will utilize the Therapeutic Dose (0.70 mg/cm2) of the Company’s lead PDC TLD-1433 and will focus on the treatment of approximately 100 BCG-unresponsive NMIBC patients who present with CIS in approximately 20 clinical sites located in Canada and the US, with a primary endpoint of efficacy and a secondary endpoint of safety. The Company is no longer pursuing European study sites due to the exorbitant costs of regulatory approval. The primary endpoint of the Study will be:Efficacy - Evaluated by Complete Response (“CR”) at any time in patients with CIS with or without papillary disease post-initial treatment duration response.The secondary endpoint of the Study will be:Duration of CR evaluated at 360 days post-initial treatment.The tertiary endpoint of the Study will be: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 = DeathShawn Shirazi, Ph.D., CEO - Drug Division, Theralase stated that, “The enrollment of the fi...

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