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.”
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
About Theralase® Technologies Inc.
Theralase is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers.
This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Wherever possible, words such as “may“, “would“, “could“, “should”, “will“, “anticipate“, “believe“, “plan“, “expect“, “intend“, “estimate“, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
SOURCE: Theralase Technologies Inc.