Theralase® Technologies Inc. (“
Theralase®” or the
“
Company”) (
TSXV: TLT)
(
OTCQB: TLTFF), a clinical stage pharmaceutical
company focused on the research and development of light activated
Photo Dynamic Compounds1 (“
PDC”) and their
associated drug formulations intended for the safe and effective
destruction of various cancers, bacteria and viruses, has
demonstrated proof-of-concept for the development of a
Canadian-made SARS-CoV-2 (“
COVID-19”) vaccine.
In August 2020, Theralase® reported that it had
executed a Sponsored Research Agreement (“SRA”)
with the University of Manitoba (“UM”) medical
microbiology department to commence research and development of a
Canadian-made vaccine, utilizing Theralase®’s patented and
proprietary PDC, TLD-1433.
In November 2020, Theralase® reported that, UM
was able to demonstrate that TLD-1433 was effective in the rapid
destruction of various viruses, including: H1N1 Influenza, Zika and
a Biological Safety Level (“BSL”)-2 coronavirus at
low nanomolar (“nM”) concentrations.
All these enveloped viruses are similar in
structure to SARS-CoV-2 virus (BSL-3), which is responsible for
COVID-19. These initial results strongly suggested that
Theralase®’s PDC technology may be used to develop an inactivated
virus vaccine2 that may be effective against COVID-19 and hence
warranted further preclinical evaluation.
Further research by UM also identified that the
spike protein responsible for the transmission of a coronavirus
into a host cell, remained intact after light-activated TLD-1433
inactivation, suggesting that the vaccine developed by this
technology could potentially stimulate a protective antibody immune
response in a mammalian host.
In April 2021, Theralase® reported that it
had executed a Collaborative Research Agreement
(“CRA”) with the Public Health Agency of Canada’s
(“PHAC”) National Microbiology Laboratory to
further expand upon the research and development achieved at UM, by
researching and developing a Canadian-based COVID-19 vaccine.
Under the terms of the agreement, Theralase® and
PHAC are collaborating on the research, development and
optimization of a COVID-19 vaccine by inactivating the SARS-CoV-2
virus with Theralase®’s light-activated PDC, TLD-1433.
Theralase® is pleased to be able to report today
that PHAC has demonstrated that light-activated TLD-1433, was
effective in rapidly inactivating the SARS-CoV-2 virus by up to
99.99%, compared to control in an in vitro study. Further research
is required to confirm these findings.
These results have now laid the groundwork for
the next phase of the CRA, which is evaluating the Theralase®
COVID-19 vaccine in the ability to prevent animals from contracting
COVID-19, when exposed to the virus.
Darwyn Kobasa, Ph.D., Head, High Containment
Respiratory Virus Group, Special Pathogens, PHAC, stated, "My
team’s initial results indicate that, when activated by light,
TLD-1433 is very effective in inactivating the COVID-19 virus at
low concentrations, thus demonstrating proof-of-concept in the
development of a Canadian-made COVID-19 vaccine.”
Kevin Coombs, Ph.D., Professor, Department of Medical
Microbiology at UM, stated, “The work conducted at my lab and the
work conducted by PHAC’s National Microbiology Laboratory, has
demonstrated that a large range of enveloped viruses can be
successfully inactivated by light-activated TLD-1433 at low
concentrations. I am delighted that Theralase®’s and my initial
preclinical research has proven to be effective in COVID-19.”
Dr. Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive
Officer and Chief Scientific Officer, Theralase® stated, “The
latest preliminary results by Dr. Kobasa and Dr. Coombs,
demonstrate that the Theralase® vaccine may potentially be
effective as a Canadian-made wholly-inactivated vaccine to prevent
individuals from contracting COVID-19 in the future and warrant
further research to confirm the findings. The research also
demonstrates that the Theralase® platform is extremely versatile,
with an ability to be applicable to a wide range of enveloped
viruses. This would allow the Company to tailor the vaccine to be
potentially effective against contracting various viruses (existing
and/or new) and their associated variants. Based on this
encouraging data, the Company intends to move forward in the
research, development and commercialization of the Theralase®
COVID-19 vaccine, subject to the required regulatory approval.”
1 |
PDCs are Light sensitive compounds that when activated by light at
a particular wavelength can produce reactive oxygen species that
can cause inactivation of cells or viruses through oxidative
stress. |
|
|
2 |
The Company does not claim or profess that they have the ability to
treat, cure or prevent the contraction of the COVID-19
coronavirus. |
|
|
About TLD-1433
TLD-1433 is a patented PDC with over 10 years of
published peer reviewed preclinical research and is currently under
investigation in a Phase II Non-Muscle Invasive Bladder Cancer
(“NMIBC”) clinical study for Bacillus
Calmette-Guérin (“BCG”)-Unresponsive patients at 5
Canadian Clinical Study Sites (“CSS”) and 7
US-based CSS.
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, bacteria and viruses.
Additional information is available at
www.theralase.com and www.sedar.com
Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Forward Looking Statements
This news release contains "forward-looking
statements" within the meaning of applicable Canadian securities
laws. Such statements include, but are not limited to, statements
regarding the Company's proposed development plans with respect to
Photo Dynamic Compounds and their drug formulations and a COVID-19
vaccine. Forward-looking statements may be identified by the use of
the words "may", "should",
"will", "anticipates",
"believes", "plans",
"expects", and similar expressions including
statements related to the current expectations of Company's
management for future research, development and commercialization
of the Company’s COVID vaccine, including preclinical research,
clinical studies and regulatory approvals.
These statements involve significant risks,
uncertainties and assumptions; including, the ability of the
Company to: adequately fund, and secure the requisite regulatory
approvals to successfully complete clinical studies for a COVID-19
vaccine in a timely fashion and implement its development plans.
Other risks include: the ability of the Company to successfully
commercialize its drug formulations, the risk that access to
sufficient capital to fund the Company’s operations may not be
available or may not be available on terms that are commercially
favorable to the Company, the risk that the Company’s drug
formulations may not be effective against the diseases tested in
its clinical studies, the risk that the Company fails to comply
with the terms of license agreements with third parties and as a
result loses the right to use key intellectual property in its
business, the Company’s ability to protect its intellectual
property, the timing and success of submission, acceptance and
approval of regulatory filings, and the impacts of public health
crises, such as COVID-19. Many of these factors that will determine
actual results are beyond the Company's ability to control or
predict.
Readers should not unduly rely on these
forward-looking statements which are not a guarantee of future
performance. There can be no assurance that forward-looking
statements will prove to be accurate as such forward-looking
statements involve known and unknown risks, uncertainties and other
factors which may cause actual results or future events to differ
materially from 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 Company cannot
assure prospective investors that actual results, performance or
achievements will be consistent with these forward-looking
statements.
All forward-looking statements are made as of
the date hereof and are subject to change. Except as required by
law, the Company assumes no obligation to update such
statements.
For More Information:
1.866.THE.LASE (843.5273)416.699.LASE
(5273)www.theralase.com
Kristina Hachey, CPAChief Financial
Officerkhachey@theralase.com416.699.LASE (5273) x 224
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