Theralase Technologies Inc (TLTFF)

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TLTFF-Patient Six Cancer-Free Eighteen Months After Single Anti-Cancer Treatment

Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations intended to safely and effectively destroy various cancers is pleased to announce that patient six, enrolled and treated in the Phase Ib Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study ("Study"), has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 540 day clinical and cystoscopy assessment.

Theralase has initiated a Phase II NMIBC clinical study ("Study II"), treating the first patient at University Health Network ("UHN") in Toronto. Additionally, McGill University Health Center has finalized their agreement for Study II and has commenced screening and enrolling patients.

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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 Guérin (“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.”

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Pre-IND Meeting
The Company completed a Pre-IND meeting with the FDA and it was confirmed that the Company's design of the Phase II ACT-NMIBC clinical study met FDA Guidance for Industry dated February 2018 on "BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment". The guideline states that "In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application."1
Shawn Shirazi, Ph.D., CEO - Drug Division, Theralase stated that "We can now proceed with completing and filing an IND application with request for fast track designation, which pending approval, would allow the Company to expeditiously and effectively extend our clinical study into the US, to qualify and onboard clinical sites. In addition, the Company is continuing to qualify Canadian sites and working towards the European Medicines Agency approval, to qualify and onboard European clinical sites for a total of approximately 20 clinical sites.

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