Toronto, Ontario (FSCwire) - Theralase Technologies Inc.
(“Theralase®” or the “Company”) (TSXV: TLT)
(OTCQX: TLTFF), a leading biotech company focused on the commercialization of medical lasers to
eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer has announced the
discovery of a new anti-cancer vaccine.
This new anti-cancer vaccine was created by exposing Rat Glioma (RG2) cancer cells,
representative of GlioBlastoma Multiforme (“GBM”), a deadly form of human brain
cancer, to proprietary and patented stressors extracorporeally (outside the body) and then
injecting this anti-cancer vaccine into rats to delay the progression of brain gliomas, utilizing a well-established animal
model of GBM.
The data obtained in this model by Theralase researchers demonstrated a significant increase of 35% in the survival
of animals versus control (no vaccination).
In previous research, Theralase reported that Rutherrin® (TLD-1433 + transferrin) injected intravenously
(“IV”) into an animal diagnosed with GBM was able to effectively cross the Blood Brain Barrier
(“BBB”) and localize preferentially to GBM tumors. Once localized, the drug is able to be activated by laser
light, and / or potentially X-ray, to safely and effectively destroy the GBM tumours.
In light of the new discovery, Theralase is currently developing a comprehensive, multi-pronged Photo Dynamic
Therapy (“PDT”) clinical procedure; whereby, a patient diagnosed with GBM would:
1) receive an IV injection of Rutherrin®.
2) receive laser light activation (via surgically inserted optical fiber and/or using conventional
trans-cranial X-ray treatment, at levels at or below standard of care), at a specified number of hours post-injection (allowing
Rutherrin® to cross the BBB and selectively be absorbed into their GBM cancer cells) to activate the drug.
3) be provided a precise treatment to safely and effectively destroy their GBM cancer, with minimum side
effects.
4) receive repeat PDT treatments to induce an immune-mediated response.
5) receive the new anti-cancer vaccine, created from their own tumour cells (or alternatively cancer cells
from another patient, which tumour(s) have a similar genetic profile), to stimulate the body’s immune cells to hunt, recognise
and destroy residual GBM cancer cells.
Malignant gliomas are not uncommon in patients, with an estimated 24,000 new cases and more than 14,000 deaths in
the US, annually. In the majority of cases, they recur following initial treatment, especially for GBM, the most common and most
lethal form of brain cancer.
Most patients do not survive beyond 2 years, post diagnosis.
For GBM patients treated with the current standard of care (i.e.: surgical removal of brain tissue, radiation and
chemotherapy (temozolomide), the National Cancer Institute of Canada’s randomized clinical study reported that the five year
Progression Free Survival (“PFS”) rate was determined to be 4%, with less than 10% of patients surviving more
than five years, post diagnosis.
In Theralase conducted research, it was demonstrated that the anti-cancer vaccine, increases well-established
biomarkers of the immunological destruction of GBM cancer cells, such as Adenosine TriPhosphate (“ATP”) and
calreticulin.
Extracellular ATP quantification:
To view the graphic in its original size, please click here
Cell surface expression of calreticulin was increased 85% over control:
To view the graphic in its original size, please click here
Proinflammatory genes: IL-1b (key regulatory cytokine), Heat Shock Protein 70 (“HSP 70”)
(important cellular stressor proven to enhance Antigen Presenting Cells (“APCs”)), Interferon-α
(“IFN-α”) (cytokine important for inducing protective anti-tumour responses) and Granulocyte Macrophage
Colony-Stimulated Factor (“GMC-SF”) (essential cytokine for processing and presenting tumor antigens for the
priming of anti-tumour cytotoxic T lymphocytes) all play a major role in the immunological response of the body to cancer
cells.
The Theralase conducted research has demonstrated that the new anti-cancer vaccine increases
expression of:
1) IL-1b by 10 times
2) HSP 70 by 10 times
3) IFN-α by 2 times
4) GMC-SF by 3 times
To view the graphic in its original size, please click here
To evaluate the new anti-cancer vaccine in animals, rats were vaccinated and then subjected to GBM induction.
Vaccinated rats were able to survive 35% longer on average than non-vaccinated rats.
To view the graphic in its original size, please click here
Post mortem evaluation detected a 700% increase in anti-cancer CD8+ T cells
(“cancer-killer” cells) in the anti-cancer vaccine GBM tissue samples.
To view the graphic in its original size, please click here
Based upon the collected data, Theralase researchers have established that the new anti-cancer vaccine, in a GBM
RG2 cancer model is able to:
1) demonstrate a source of tumor antigens for an immunologic, tumour specific, anti-cancer response
2) potentially target micro-metastases of GBM in the brain unable to be removed by surgical intervention
3) restore the body’s own complex immune and defense mechanisms to recognize and destroy GBM cancer
cells.
Next steps planned by the Company to commercialize this technology include: optimization of the pre-clinical animal models,
followed by a Phase Ib clinical study in a patient population presenting with GBM disease and pre-existing tolerance mechanisms,
which are actively retarding the immune recognition and destruction of tumours in these cancer patients.
Manjunatha Ankathatti Munegowda, Ph.D., DVM, Research Scientist, Theralase, stated that, “In order to be effective,
an anti-cancer vaccine must have an ample supply of antigens and be able to provide secondary responses required to stimulate the
body to elicit an effective immune response. The Theralase anti-cancer vaccine has both, possessing multiple tumour antigens and
adjuvants such as: TNFa and IL-1b. This anti-cancer vaccine could be used along with current debulking strategies, to help
eliminate any residual disease. It is also able to serve as a protective vaccine to target and eliminate any possible
relapses.”
Mark Roufaiel, Ph.D., Research Scientist, Theralase stated, “The data supports that the anti-cancer vaccine induces
immunogenic changes in the highly aggressive GBM RG2 model. Our results demonstrate that the anti-cancer vaccine treated GBM RG2
cancer cells may be a source of tumor related antigens for induction of an immunologic, tumour specific, anti-cancer, therapeutic
response. This advanced vaccination approach induces a potent anti-tumour effect with significant delay in tumour progression,
and significant increase in animal survival; therefore, this new anti-cancer vaccine may be an ideal treatment to improve the
clinical outcomes of standard of care treatments of various cancers; including, highly recurrent and/or treatment resistant
tumours.”
Arkady Mandel M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase and the originator of Theralase’s vaccine
technology stated, “As tumour cells frequently undergo high rates of mutation, resulting in the loss of single or multiple
antigens, it would be ideal to choose a source of an antigen that can elicit a broad tumour-specific response. Theralase’s
anti-cancer vaccine was designed to offer this distinct advantage, allowing APCs to process and present numerous patient specific
tumour antigens to stimulate a strong T cell immunological response to prevent tumour escape. The stimulated CD4+ Th cells could
also provide assistance to CD8+ T cells to generate a more direct and robust anti-tumour immunity and long-term memory. Moreover,
the Theralase anti-cancer vaccine has been created to be suitable for all cancer patients, regardless of their diagnosis and / or
human leukocyte antigen type. The Theralase anti-cancer vaccine based immunotherapy offers an exciting opportunity to target
specific cancers, by becoming the “master regulator of immune responses” via activation of the most
potent APC population for priming and activating naïve T cells to recognize and combat tumours.
Roger Dumoulin-White, P.Eng., President and CEO of Theralase stated that, “In the international scientific and
medical community, it has long been understood that the immune system is the key to conquering cancer. We’re now at a point in
the Company’s research and development phase, where this knowledge can be effectively translated into treatment solutions, such
as this new anti-cancer vaccine, used in conjunction with our existing anti-cancer technology, to help cancer patients combat and
defeat this deadly disease.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV:
TLT) (OTCQX: TLTFF) in its Therapeutic Laser Technology (“TLT”)
Division designs, manufactures, markets and distributes patented super-pulsed laser technology indicated for the treatment of
chronic knee pain, and in off-label use, the elimination of pain, reduction of inflammation and dramatic acceleration of tissue
healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT”) Division
researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which have
demonstrated an ability to localize to cancer cells and then when laser light activated, effectively destroy them.
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 the proposed use of proceeds. 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. 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 news 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:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com
To view this press release as a PDF file, click onto the following link:
public://news_release_pdf/Theralase11202017.pdf
Source: Theralase Technologies Inc. (TSX Venture:TLT, OTCQX:TLTFF, FWB:TTX)
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