RE:News is out - a new site in Canada is contracted McGill University Health Centre Newest Clinical Study Site for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
TORONTO, ON / ACCESSWIRE / July 30, 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, is pleased to announce that McGill University Health Centre “MUHC”) Research Ethics Board (“REB”) has approved the commencement of a Phase II Clinical Study to enroll and treat Patients with Non-Muscle Invasive Bladder Cancer (“NMIBC”), who present with Carcinoma In-Situ (“CIS”) and who are considered BCG-Unresponsive or are intolerant to BCG Therapy (“Study II”), subject to a Site Initiation Visit (“SIV”) and Site Qualification Visit (“SQV’), scheduled for early September.
MUHC is one of the leading academic health centres in the world and attracts clinical and research expertise from around the world, assessing the latest in medical technology and training the next generation of medical professionals.
Wassim Kassouf, MD, CM, FRCSC, Professor and Associate Chair, MUHC stated, “We are very excited to open this clinical study that provides access to evaluate the efficacy of a novel therapeutic approach for patients who cannot tolerate Baccilus Calmete Gurin (“BCG”) or have BCG-unresponsive disease; addressing a large unmet need for bladder cancer patients.”
Shawn Shirazi, Ph.D., CEO - Drug Division, Theralase stated that, “I am pleased with the addition of MUHC to the Company’s Phase II clinical study sites. MUHC, pending the completion of a SQV / SIV, is able to commence the enrollment and treatment process of BCG-unresponsive NMIBC patients for the Phase II Study. I believe with the recent announcement of the Trial Management Organization agreement combined with world-class organizations such as University Health Network in Toronto, MUHC in Montreal and numerous other Canadian and US clinical study sites currently in negotiations with Theralase, the opportunity to successfully enroll and treat the approximately 100 patients needed to complete the study.”
About Phase II Study
Study 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 measured by Complete Response (“CR”) at any time, a secondary endpoint of duration of CR and a tertiary 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 12 to 18 months 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 = Mild
Grade 2 = Moderate
Grade 3 = Severe
Grade 4 = Life-threatening or disabling
Grade 5 = Death
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