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, intended to safely and effectively destroy cancer, has
announced significant benefits of its Rutherrin® (TLD-1433 + transferrin) formulation in comparison to a
clinically approved PDC Amino Levulinic Acid (“ALA”), in the destruction of Rat Glioma
(“RG2”) brain tumours, representative of GlioBlastoma Multiforme
(“GBM”), a deadly form of human brain cancer.
As previously disclosed, Theralase demonstrated that rats subjected to RG2 cancer cells, developed brain tumours
representative of GBM. After intravenous (“IV”) injection of Rutherrin® and subsequent laser light activation,
these animals survived significantly longer that animals who did not receive treatment and/or were treated with ALA-PDT.
Further research conducted by Theralase researchers has demonstrated that Rutherrin® is able to provide a
significant (up to 400 %) improvement in survival in animals treated with Rutherrin® versus IV injection of ALA and subsequent
laser light activation. (Figure 1)
Figure 1. Animal Survival Analysis (Kaplan-Meir)
To view the graphic in its original size, please click here
Magnetic Resonance Imaging (“MRI”) data obtained from the pre-clinical experiments show
that in the animals treated with Rutherrin® there was less non-specific inflammation in the brain as compared to ALA treated
animals.
This observation is considered clinically advantageous; as excessive inflammation of brain tissue is known to cause
post-treatment clinical complications, such as: lethal damage to brain tissue (cerebral death), bleeding in the brain
and/or stroke due to increased intracranial pressure through the brain’s confinement in the skull. (Figure 2)
Figure 2. MRI data
To view the graphic in its original size, please click here
Inductively Coupled Plasma Mass Spectrometry (“ICP-MS”), a type
of mass spectrometry, which is capable of detecting PDCs in tissues at concentrations as low as one part in
1015 (part per quadrillion), demonstrated a significant RG2 (representative of GBM) specific PDC uptake, at
20-fold more in tumour versus normal (non-cancerous) brain tissue. Specific uptake by RG2 was investigated for various Rutherrin®
doses and has been shown to be maintained for up to 20 hours in cancerous brain tissue commencing 4 hours post IV injection.
The highly specific uptake of Rutherrin® by RG2 tumours, provides an enhanced safety profile for Rutherrin® therapy
and increases the time span over which a patient can be treated. It was shown that a 20-fold increase of Rutherrin® PDC in tumour
versus healthy brain tissue enabled a higher tumour destruction, while reducing treatment related morbidity. (see Figure 3).
Figure 3: Rutherrin® Uptake Ratio (ICP-MS analysis)
To view the graphic in its original size, please click here
Theralase researchers have also observed an increased number of anti-tumour specific immune cells in brain tissue
treated with Rutherrin® versus ALA treated animals. This is quantified by observing the density of intratumoural, anti-cancer
CD8+ T cells in GBM tumors. (Figure 4)
Clinical case studies of various cancers have demonstrated an increased survival in patients who possess a high
density of intratumoural, anti-cancer CD8+ T cells in their respective tumours. It has been reported that an elevated
level of tumour-infiltrating immune cells, such as anti-cancer CD8+ T cells, correlate with prolonged survival in GBM patients.
(Justyna Kmiecik et. al Journal of Neuroimmunology 264 (2013) 71–83).
Figures 4. Immunohistochemistry slides and their computerized quantification bar graphs showing the
recruitment of CD8+ T cells in the tumor microenvironment.
To view the graphic in its original size, please click here
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 the cases, they recur following initial treatment, especially for GBM, the most common and
lethal form of brain cancer.
Manjunatha Ankathatti Munegowda, Ph.D., DVM, Research Scientist, Theralase stated that “In the current study, comparing
Rutherrin® with the FDA approved PDC ALA, have shown the significant benefits of using Rutherrin® in this application. The safety
aspects of Rutherrin® will be a game changer in clinics treating brain cancer due to: the significant selective uptake of
Rutherrin® in cancerous tissue versus normal tissue, the comparatively reduced inflammation of brain tissue and the improved
immune response of Rutherrin® treatments. All of these Rutherrin® characteristics would be extremely useful in targeting and
eliminating any recurrences.”
Lothar Lilge, Ph.D., Professor, University of Toronto stated that, “Rutherrin® as a PDC for PDT, particularly in
the brain region, has various critical and potentially life-saving benefits for GBM patients:
- The ability to use near infrared wavelength activation at clinical dose allows treatment of a much larger tumour volume
than visible wavelength activated PDCs, such as ALA;
- A highly specific drug uptake ratio (cancerous versus healthy brain tissue) that allows a neurosurgeon the ability to
extend the activation of Rutherrin® deep into the brain, enabling treatment of more complete “cancer affected” areas; including
micro metastasis regions, that are unfortunately common in GBM patients, and are predominately responsible for cancer
recurrence. The use of transferrin as the TLD-1433 delivery vehicle also allows an efficient and highly targeted drug delivery
over the intact blood-brain barrier. An intact blood-brain barrier prevents the delivery of a majority of drugs including PDCs,
but this issue has been circumvented by Rutherrin®.
- Reduction of inflammation post-PDT treatment with an increase in immune activity are further benefits to the survival of
animals in tested pre-clinical models.
Taking all of these advantages together and translating them into the clinic has the highest potential to increase
the median survival of GBM patients and increase the survival rate of patients well beyond 3 or even 5 years. Relapses are common
in GBM patients, who are treated with FDA approved therapies, with a majority of patients not surviving beyond 2 years
post-diagnosis. Terminally ill patients will be eligible for experimental drug therapies under a new Right to Try bill recently
signed into law in the USA. Under this bill, we could potentially speed up clinical development of Rutherrin® for the treatment
of life-threatening brain cancers.”
Arkady Mandel M.D., Ph.D., D.Sc., Interim CEO and Chief Scientific Officer, Theralase stated that, “The Company’s
pre-clinical studies continue to show significant advantages of light activated Rutherrin® in the treatment of brain tumours,
such as GBM. Building upon these encouraging results, we now can further optimise Theralase’s technology and improve its
anti-tumour potency; including Rutherrin® induced specific, anti-tumour, CD8+ T-cells activity in the treatment of high-grade
gliomas, such as GBM. Considering these strong pre-clinical results, Theralase will commence contacting clinical oncology
neurosurgeons to join our Medical and Scientific Advisory Board to help design a clinical Phase Ib GBM clinical study for
patients diagnosed with GBM with the intention to safely and effectively destroy their cancer with minimal side effects.”
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 cancer. 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 in regards to 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: obtain regulatory approval to
commence a Phase Ib GBM clinical study, successfully fund and complete a Phase Ib
GBM clinical study and to 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 the 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
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Source: Theralase Technologies Inc. (TSX Venture:TLT, OTCQX:TLTFF, FWB:TTX)
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