Toronto, Ontario – June 11, 2021, Theralase® Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of innovative Anti-Cancer Therapy (“ACT”) technologies intended to safely and effectively destroy various cancers, bacteria and viruses, while preserving patient Quality Of Life (“QOL”) announced today the launch of the seventh US-based Clinical Study Site (“CSS”); specifically, the University of Chicago Medicine (“UChicago Medicine”). UChicago Medicine has successfully received Institutional Review Board (“IRB”) approval allowing them to commence enrollment and treatment of patients in Theralase®’s pivotal Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC“) Clinical Study (“Study II”).
Study II is focused on the enrollment and treatment of approximately 100 to 125 patients, who have been previously diagnosed with Bacillus Calmette Guérin (“BCG“)-Unresponsive Carcinoma In-Situ (“CIS“) or who are intolerant to BCG therapy (“Study II“).
The Company has successfully launched five CSSs in Canada and 7 in the US for patient enrollment and treatment in Study II.
UChicago Medicine, with a history dating to 1927, is a not-for-profit academic medical health system based on the campus of the University of Chicago in Hyde Park, with hospitals, outpatient clinics and physician practices located throughout Chicago and its suburbs. UChicago Medicine translates fundamental scientific discoveries into better care for their patients and performs more clinical trials than any other hospital in Illinois.
Dr. Piyush Agarwal, MD, Professor of Surgery and Urology, Director, Bladder Cancer Program, Fellowship Director, Urologic Oncology, at UChicago Medicine stated, “This technology harnesses the power of near infrared light produced by a laser to destroy localized bladder cancer cells that have not responded to standard of care therapy such as BCG. It gives patients an option to consider before bladder removal.”
Dr. Agarwal’s clinical and laboratory research focuses primarily on bladder cancer, specifically BCG-Unresponsive disease, the urinary microbiome, molecular targeted therapy and immunotherapy. He has conducted several original, investigator-initiated clinical studies and has presented his research at national and international meetings. Dr. Agarwal has served on the Food and Drug Administrations (“FDA”) oncologic drug advisory committee and has authored six book chapters and over 90 manuscripts.
The first US-based patient in Study II was recently treated at Virginia Urology (“VU”) ( Richmond, Virginia).
VU has a long history of providing quality care to the Greater Richmond metro area for over 75 years. VU prides itself on its strong commitment to the community’s urological needs by recruiting highly skilled physicians and using the latest technology. VU is comprised of over 40 physicians that include urologists and urogynecologists as well as physicians specializing in the urologic aspect of anesthesiology, pathology, radiation oncology, and radiology. Because VU has such diverse medical professionals, they are able to provide the latest technologies with their mission of providing the best possible care for each patient.
To date, Study II has enrolled and provided the primary study treatment for 20 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 23 patients.
Shawn Shirazi, PhD, Chief Executive Officer of Theralase®, stated, “It is exciting to see Theralase® clear another hurdle by treating the first patient in the US and move one step closer to achieving its next milestone of enrolling and treating twenty-five patients in early 2021. Once completed, Theralase® plans to submit the clinical assessment data on the first twenty-five patients treated in Study II to the FDA for consideration of Break Through Designation (“BTD”) status.”
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, CPA
Chief Financial Officer
416.699.LASE (5273) x 224