Toronto, Ontario – January 25, 2021, Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (“PDC”) and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that MidLantic Urology (“MU”) has received site Institutional Review Board (“IRB”) approval to commence a Pivotal Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC“) Clinical Study to enroll and treat patients with Bacillus Calmette Guerin(“BCG“)-Unresponsive Carcinoma In-Situ (“CIS“) or who are intolerant to BCG Therapy (“Study II“).
This marks the third US clinical site that has obtained both study level and site IRB approval through a central IRB. There are 3 pending US clinical study sites that are expected to receive site IRB approval in 1Q2021.
MU, headquartered in Philadelphia, Pennsylvania, is a state-of-the-art urologic care center that embraces independent practice, innovation and research to improve patient outcomes. MU has 70+ physicians and 47 locations located throughout the region. Their world-class physicians set new standards in comprehensive urologic patient care and continue to innovate with the most advanced treatments backed by clinical research. The MU team thrives on pushing the envelope of what’s possible in urological medicine.
Dr. Laurence H. Belkoff, DO, MSc. FACOS, Director of Clinical Research for MU stated “We are excited to work with Theralase for the NMIBC clinical study. Tackling cancer is a crucial topic and a priority for this region, and I am pleased that MU is able to contribute to the growth of innovative cancer research by taking part in this study”.
With the addition of MU, the Company now has 5 clinical study sites open in Canada and 3 in the US for patient enrollment and treatment for Study II.
Shawn Shirazi PhD, Chief Executive Officer, Theralase®, stated, “Another milestone has been reached by the Company with the addition of MU in Pennsylvania as a clinical study site. Theralase is focused on its target of enrolling and treating 11 additional patients in early 2021 for a total of 25 patients for potential Breakthrough Designation Approval and approximately 100 patients in 2021 / 2022.”
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, bacteria and viruses.
Forward Looking Statement
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:
Kristina Hachey, Chief Financial Officer