Toronto, Ontario – June 28, 2022, 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 (“PDCs”) and their associated drug formulations, used to destroy various cancers, bacteria and viruses, safely and effectively, is pleased to announce that the Company has expanded its Intellectual Property (“IP”) portfolio.
Theralase® has recently been granted a Brazilian patent for, “Metal-Based Thiopene Photodynamic Compounds and their Use” (“Patent”).
The patent advances Theralase’s intellectual property portfolio internationally strengthening the patent portfolio around the Anti-Cancer Technology (“ACT”) platform. The patent encompasses an extensive library of PDCs, including Theralase’s lead PDC, TLD-1433, approved by Health Canada to be evaluated in a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”).
The Mechanism of Action (“MOA”) of the patented Theralase® PDCs involves selective localization of the PDC inside the cancer cells of interest and then activating it by laser light to produce highly reactive free radicals, such as, singlet oxygen and Reactive Oxygen Species (“ROS”), temporally and spatially to destroy the cancer cells, with minimum impact on healthy cells.
This patent further strengthens the extensive portfolio of patents already held by Theralase®. The Company is focused on increasing shareholder value, by providing the Company international patents to protect its unique technology, as the Company moves closer towards commercialization.
Currently, Study II has successfully been launched in 12 Clinical Study Sites (5 – Canadian and 7 – United States) with 41 patients treated.
Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer (“CEO”) and Chief Scientific Officer (“CSO”), Theralase® stated that, “This patent is strategic to opening up new international opportunities for Theralase® by expanding its IP portfolio of medical laser and oncology focused technologies internationally. Theralase®’s long-term strategy is to commercialize the Anti-Cancer Therapy (“ACT”) technology commencing with NMIBC and expanding into Non-Small Cell Lung Cancer (“NSCLC”), Glioblastoma Multiforme (“GBM”) and other various cancer indications to provide a safe, effective, and rapid alternative treatment option for patients inflicted with these deadly diseases. The ability to provide personalized treatment for cancer patients to “hunt and destroy” their cancer and prevent its recurrence and progression, all in a single or dual treatment, remains at the forefront of our research and development objectives”.
About Study II
Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm 2 ) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ (“CIS”) patients in up to 15 Clinical Study Sites (“CSS”) located in Canada and the United States.
Study II Objectives:
- Primary – Efficacy (defined by CR) at any point in time.
- Secondary – Duration of CR (defined by duration of CR lasting a minimum 360 days post-initial CR).
- Tertiary – Safety measured by incidence and severity of AEs Grade 4 or higher that do not resolve within 450 days post primary study treatment. (Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Serious, Grade 4 = Life Threatening and Grade 5 = Death)
TLD-1433 is a patented PDC with over 10 years of published peer-reviewed preclinical and clinical research and is currently under investigation in Study II.
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statement
This news release contains “forward-looking statements” within the meaning of applicable Canadian securities laws. 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 and a COVID-19 vaccine. Forward looking statements may be identified by the use of the words “may, “should“, “will“, “anticipates“, “believes“, “plans“, “expects“, and similar expressions including statements related to the current expectations of Company’s management for future research, development and commercialization of the Company’s COVID vaccine, including preclinical research, clinical studies and regulatory approvals.
These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to: adequately fund, and secure the requisite regulatory approvals to successfully complete clinical studies for a COVID-19 vaccine in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its drug formulations, the risk that access to sufficient capital to fund the Company’s operations may not be available or may not be available on terms that are commercially favorable to the Company, the risk that the Company’s drug formulations may not be effective against the diseases tested in its clinical studies, the risk that the Company’s fails to comply with the term of license agreements with third parties and as a result loses the right to use key intellectual property in its business, the Company’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the Company’s ability to control or predict.
Readers should not unduly rely on these forward- looking statements which are not a guarantee of future performance. There can be no assurance that forward looking statements will prove to be accurate as such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from 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.
All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements.
For More Information:
Kristina Hachey, CPA
Chief Financial Officer
416.699.LASE (5273) x 224