Toronto, Ontario – June 24, 2022, 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 (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers is pleased to announce that Theralase®’s research, published in Translational Biophotonics (“TBIO”), is one of the top 10 most downloaded papers in TBIO, amongst work published between January 1, 2019 to December 31, 2020.
According to the TBIO’s website, TBIO is an international peer-reviewed, open access journal dedicated to bridging the gap in translating medical photonic research into clinical practice. TBIO serves as a platform for translating photonic methods and technologies in all medical areas to solve unmet medical needs in diagnosis and therapy.
The symbiosis between photonics and medicine serves as the bridge in integrating translational research into clinical practice.
The Theralase® sponsored research entitled, “Evaluation of a Ruthenium coordination complex as photosensitizer for Photo Dynamic Therapy (“PDT”) of bladder cancer: Cellular response, tissue selectivity and in vivo response” (“Publication”) demonstrated that the combination of TLD-1433 activated by green laser light resulted in the selective and effective destruction of various cancer cell lines both in-vitro and in-vivo, including the complete eradication of urothelial bladder tumours along with protecting normal bladder muscle function.
The publication can be accessed online at:
Evaluation of a Ruthenium coordination complex as photosensitizer for PDT of bladder cancer: Cellular response, tissue selectivity and in vivo response – Lilge – 2020 – Translational Biophotonics – Wiley Online Library
In conclusion, the Publication stated that, “Combination of TLD-1433 instillation and the use of green PDT activation light results in a steep PDT gradient providing one avenue to protect normal muscle function. The high selective uptake of TLD-1433 is very favorable to compensate for heterogeneities in the bladder wall irradiance, and the absence of visible damage to the muscle layers also opens an avenue for the treatment of Muscle Invasive Bladder Cancer (“MIBC”) in addition to targeting Non-Muscle Invasive Bladder Cancer (“NMIBC”).”
Lothar Lilge Ph.D., senior staff scientist, UHN stated “In my lab, TLD-1433 based PDT has been proven in numerous in-vitro and in-vivo studies to be an effective and viable treatment for the destruction of numerous human and animal cancers. Upon irradiation with laser light, TLD-1433 produces highly aggressive Reactive Oxygen Species (“ROS”) and hydroxyl radicals, spatially and temporally, which have been proven to be deadly to cancer cells. I am humbled that research, where I was the lead author, became one of the top 10 downloaded papers from TBIO in the 12 months following its publication. The research which I co-authored has now successfully translated from the laboratory bench to clinical studies: firstly, in the successfully completed Theralase® Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (safety and efficacy study) and secondly, in the pivotal Theralase® Phase II NMIBC clinical study, currently in progress. I am excited to see, from the preliminary clinical data Theralase® has accumulated to date, that Theralase® is advancing well to achieve the primary, secondary and tertiary Study II objectives”
Dr. Arkady Mandel M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase® stated, “This is another milestone of excellence achieved by Theralase®. These pre-clinical results led a logical progression to our successfully completed Phase Ib NMIBC clinical study, which demonstrated the safety, pharmacokinetics and efficacy in a first in-human clinical study. The success in the Phase Ib NMIBC clinical study has led to the impressive preliminary results demonstrated in the Phase II NMIBC clinical study, focused primarily on efficacy and secondarily on safety. In the future, I foresee great potential for Theralase® Anti-Cancer Therapy (“ACT”) to deliver a safe and effective anti-cancer treatment for numerous cancer indications with high unmet needs.”
About Study I
The Study’s primary objective was safety and tolerability of PDT, with a secondary objective of pharmacokinetics ((drug evacuation from the body)) and a tertiary objective of efficacy (Complete Response (“CR”) primarily at 90 days and secondarily at 180 days for patients treated at the maximum recommended starting dose (0.35 mg/cm2 ) and the therapeutic dose (0.70 mg/cm2)). Patients who were treated at the therapeutic dose, consented to be followed clinically for 18 months, post initial treatment.
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