Toronto, Ontario (FSCwire) - 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”)
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).
To view the graphic in its original size, please click here
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.
To view the graphic in its original size, please click here
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.
To view the graphic in its original size, please click here
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 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 complete the preclinical
research and development, secure the requisite regulatory approvals to commence a Phase Ib NSCLC clinical study, fund and
implement its development plans, including with respect to commencing a Phase II NSCLC clinical study. 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
To view the associated document to this release, please click on the following link:
public://news_release_pdf/theralase03052018.pdf
To view the original release (with media), please click here
Source: Theralase Technologies Inc. (TSX Venture:TLT, OTCQX:TLTFF, FWB:TTX)
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