Rutherrin® Technology Granted Allowance for Canadian Patent
Toronto, Ontario – March 7, 2018
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations to safely and effectively destroy various cancers, announced today that it has been notified that it has been granted allowance for a Canadian patent to issue later this year for Rutherrin® (TLD-1433 PDC combined with transferrin) for the treatment of cancer.
Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase® and the inventor of the technology stated that; “Allowance of one of the Company’s key patents is timely as we approach the completion of enrollment in our Phase Ib trial for Non-Muscle Invasive Bladder Cancer (“NMIBC”). If successful, the Company looks forward to commencing Phase II NMIBC clinical study. The Company is currently completing preclinical research and entering into clinical development for two additional cancer indications; specifically: GlioBlastoma Multiforme (“GBM”), a deadly form of brain cancer and Non-Small Cell Lung Cancer (“NSCLC”). This patent, when issued, will validate the proprietary position of the Company’s Rutherrin® technology for the Canadian healthcare market, demonstrating Theralase’s ongoing commitment to the development of a comprehensive intellectual property portfolio, attractive to an early stage partner.”
Rutherrin® technology encompasses the use of a wide range of compounds from Theralase’s expansive library of patented metal-based PDCs, combined with a metal-binding glycoprotein, such as transferrin.
Rutherrin® has been designed for intravenous administration and has been demonstrated preclinically to be highly effective in a number of established animal models of human cancer, including GBM and NSCLC.
The allowance of this patent positions Theralase® to launch its Rutherrin® technology throughout Canada, following the successful completion of its ongoing preclinical program.
Next steps planned by the Company to develop this technology include:
1. Recruitment and retention of neurological and thoracic oncology specialists to the Theralase® Medical and Scientific Advisory Board (“MSAB”) to advise the Company on clinical study design;
2. Optimization of the preclinical research for GBM and NSCLC and if successful;
3. Design and commencement of Phase Ib GBM and NSCLC clinical studies
On the cellular surface of all cells, there are carrier proteins known as Transferrin Receptors (“TfRs”). The TfR’s main role is to link with the glycoprotein Transferrin (“Tf”) to enable the cell to absorb iron, an essential element required for energy production and metabolism.
Due to the high proliferation rate of cancer cells (which makes them so deadly to the human body), they possess a greater quantity of TfRs and hence they absorb a greater quantity of iron than normal cells.
TLD-1433 is a Theralase® patented ruthenium metal-based molecule. Ruthenium is a transitional VIII metal element (as is Iron and Osmium), in the periodic table, that possesses similar properties to iron.
Theralase® has demonstrated that TLD-1433 bonds with transferrin to produce Rutherrin® and in so doing, TLD-1433 is able to be selectively transported, preferentially, and in much higher quantities to cancer cells versus normal cells through the TfR.
Once inside the cancer cell, TLD-1433, when light activated, produces a violent form of oxygen, known as Reactive Oxygen Species (“ROS”), that is able to effectively destroy the cancer cell from the inside out.
According to the Canadian patent’s claims, that will issue later this year, Rutherrin® possesses one or all of the following characteristics:
a) increased uptake by cancer cells;
b) increased efficacy at wavelengths less than, equal to or longer than 600 nm;
c) increased production of ROS;
d) increased Photo Dynamic Therapy (“PDT”) effect under hypoxic or non-hypoxic conditions;
e) increased Maximum Tolerated Dose (“MTD”);
f) increased photostability; and / or
g) increased shelf-life
Rutherrin® technology is patent pending in the United States, European Union, Brazil, Russia, India and China. These countries account for approximately 65% of the world’s Gross Domestic Product (“GDP”) (2015 statistics). If patents are allowed to issue in these countries, the Rutherrin® technology will be able to be fully commercialized and protected in these major medical markets.
In 2016, an estimated 79,030 adults (60,490 men and 18,540 women) were diagnosed with bladder cancer in the United States. Among men, bladder cancer is the fourth most common cancer. It is estimated that 16,870 deaths (12,240 men and 4,630 women) from this disease will occur in 2016. Among men, bladder cancer is eighth most common cause of cancer death.
There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 14,000 deaths. In the majority of cases, they recur following initial treatment, especially for GBM, the most common and lethal form of brain cancer. Most patients do not survive beyond 2 years, post diagnosis.
Lung cancer is by far the leading cause of cancer death among both men and women. Out of all types of lung cancer, NSCLC accounts for 80 to 85% of cases. The American Cancer Society’s estimates for lung cancer in the United States for 2018 are:
· About 234,030 new cases of lung cancer (121,680 in men and 112,350 in women)
· About 154,050 deaths from lung cancer (83,550 in men and 70,500 in women)
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations to safely and effectively destroy various cancers. The Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions.
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 development and commercialization of the TLC-2000, including with respect to ongoing redesign work and regulatory clearance process for expanded claims and the Company’s development and commercialization strategy with respect to its Anti-Cancer Technology. 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 successfully complete the redesign work under the proposed timeframe and scope of work or at all, the availability of financing to advance the development of the TLC-2000, the ability of the Company to secure further regulatory clearances (including with respect to expanded claims) from Health Canada and/ or the FDA with respect to the TLC-2000 under the proposed timeframe and scope or at all, the ability of the Company to achieve wider commercial distribution of the TLC-2000, the ability of the Company to execute its strategy with respect to its Anti-Cancer Technology, the ability of the Company to secure further regulatory approvals from Health Canada and/ or the FDA for its NMBIC clinical studies and the ability of the Company to finalize development of, and successfully commercialize, its Anti-Cancer Technology. 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 news 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.
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