Toronto, Ontario – March 5, 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 its lead compound, TLD-1433, when combined with transferrin to form Rutherrin®, has been demonstrated to target and effectively kill human lung cancer cells, in two preclinical animal models.
According to the American Cancer Society, lung cancer is the second most common cancer in both men and women, next to skin cancer, with about 14% of all new cancers diagnosed as lung cancer.
Lung cancer is by far the leading cause of cancer death among both men and women. Each year, more people die of lung cancer than of colon, breast, and prostate cancers, combined.
Out of all types of lung cancer, Non-Small Cell 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)
Depending on the stage of the cancer and other factors, treatment options for people with NSCLC can include:
– Radio Frequency Ablation (“RFA”)
– Radiation therapy
– Targeted therapies
The five-year survival rate for NSCLC varies from 45% in early stages of the disease to less than 1% in later stages of the disease. More than half of the people diagnosed with lung cancer die within one year of being diagnosed.
On their 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 allow 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 chemical 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.
In the Company’s earlier press release, the Company demonstrated that human NSCLC cell lines expressed very high quantities of TfRs. In tissue culture studies, the Company demonstrated that TLD-1433 was effective at destroying multiple NSCLC cell lines.
To further explore the efficacy of Rutherrin® in the destruction of NSCLC, the Company has recently evaluated clinically relevant subcutaneous (under the skin) and orthotopic (tumours grown inside organs) models of NSCLC.
In the subcutaneous tumour model, human NSCLC tumour cells (A549) were subcutaneously injected to induce a NSCLC tumour in mice. Once tumour presence was confirmed, the mice were injected intravenously with Rutherrin®. At 4 hours post Rutherrin® injection, mice were treated with Near Infra Red (“NIR”) light. Tumour samples 48 hours post treatment were analyzed to evaluate the efficacy of Rutherrin® in the destruction of NSCLC tumours.
Figure 1A illustrates the efficacy of Rutherrin® in the destruction of NSCLC subcutaneous tumours, demonstrating an approximately 600% increase over control. Necrotic areas (dead cancer cells) correlated well with proliferating cell marker Ki67, assessed by immunohistochemistry, showing an approximately 600% higher number of proliferating cells in untreated controls versus Rutherrin® treated cells (Figure 1B).
Figure 2: Representative photomicrographs of tumour sections from subcutaneous NSCLC tumour model showing pink necrotic area (shown by arrows). A and B are untreated control, C and D are 48 hours post Rutherrin® treatment.
In a preclinical orthotopic tumour model, that is clinically relevant, human NSCLC tumour cells were used to induce lung tumours in mice. Once tumour presence was confirmed, the mice were injected intravenously with Rutherrin®. 40 hours post Rutherrin® injection, the mice were intubated (hollow tube inserted into trachea) and NSCLC tumours were treated by intrathoracic light delivery. This treatment strategy is depictive of the clinical strategy to be used for human patients inflicted with NSCLC. Fourty-eight hours post light activation, tumour samples were collected for analysis. Results demonstrate that light activated Rutherrin® treatment induced extensive areas of necrosis (cell death) in NSCLC tumours (Figure 3).
In order to optimize the treatment in humans, the Company will standardise the dose of Rutherrin® and the fibre optic light delivery system to the NSCLC tumours to increase efficacy.
Figure 3: Representative photomicrographs of tumour sections from clinically relevant orthotopic NSCLC tumour models showing pink necrotic area (shown by arrows). A and B are untreated controls, C and D are 48 hours post light activation.
Manjunatha Ankathatti Munegowda, Ph.D., DVM, Research Scientist at Theralase®, stated that, “We are delighted to have demonstrated that light activated Rutherrin® is efficient in selectively destroying NSCLC cells in both a subcutaneous and an orthotopic animal model. The orthotopic model is important in that it demonstrates the suitability of this treatment methodology to human clinical cases, as Rutherrin® was delivered intravenously and the laser light was delivered directly into the lungs via fibre optics inserted through the trachea. This strong data will assist the Company to provide evidence to thoracic surgeons and oncologists to support a Phase Ib clinical study for NSCLC.”
Arkady Mandel, M.D., Ph.D., D.Sc., interim Chief Executive Officer and Chief Scientific Officer of Theralase® stated that, “The Company is delighted in the outcome and quality of the preclinical work. This research lays the ground work for further preclinical experiments to optimize the dose of Rutherrin® and laser light delivery strategy and if proven successful, the commencement of a Phase Ib clinical study for NSCLC, the leading cause of cancer related death.”
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.
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 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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