Toronto, Ontario – March 4, 2019
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 (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers, announced today that it has been granted allowance for a United States patent to issue later this year for destroying cancer cells with X-ray activated PDCs.
The new patent to issue later this year is entitled, “Photodynamic Compounds and Methods for Activating Them Using Ionizing Radiation and/or Other Electromagnetic Radiation for Therapy and/or Diagnostics”
Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase® and the lead inventor of the technology stated that, “In 2019, the Company plans to commence a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC“) clinical study, which if successful may lead to commercialization of this technology in Canada, the United States and the European Union. On top of this clinical study, this patent opens up new possibilities with far reaching oncological treatment implications, including: targeting cancers that are difficult, if not impossible to reach with surgery or conventional laser light sources, such as Glio Blastoma Multiforme (“GBM“), a deadly form of brain cancer, Non-Small Cell Lung Cancer (“NSCLC“) or other deep tissue related cancers, such as soft tissue sarcomas. The Company is investigating evaluating Rutherrin® (TLD-1433 PDC combined with transferrin) in combination with X-ray in a Phase Ib clinical study for GBM. This patent, when issued, will validate the proprietary position of the Company’s Anti-Cancer Technology (“ACT“) for the US oncology market, demonstrating Theralase’s strong commitment to the development of a comprehensive intellectual property portfolio, attractive to a pharmaceutical partner.”
About Rutherrin®
On the surface of all cells, there are carrier proteins known as Transferrin Receptors (“TfRs“). These 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, the 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.
About NMIBC
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.
About GBM
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.
About NSCLC
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 and their associated drug formulations intended to safely and effectively destroy various cancers.
Additional information is available at www.theralase.com and www.sedar.com
This news release contains “forward-looking statements” which reflect the current expectations of management of the Corporation’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding Theralase’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 Theralase to: successfully fund and complete a Phase II NMIBC clinical study, successfully fund and complete a Phase Ib GBM clinical study, successfully fund and complete a Phase Ib NSCLC clinical study, secure the requisite regulatory approvals to commence and fund a Phase II NMIBC clinical study, Phase Ib GBM clinical study and/or a Phase Ib NSCLC clinical study and implement its development plans. Many factors could cause the Corporation’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 Corporation 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 Corporation cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Corporation 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:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
info@theralase.com
www.theralase.com