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 Compounds (“
PDCs”) and their
associated drug formulations, used to destroy various cancers,
bacteria and viruses, safely and effectively, is pleased to
announce that the Company has expanded its Intellectual Property
(“
IP”) portfolio.
Theralase® has recently been granted a Brazilian
patent for, “Metal-Based Thiopene Photodynamic Compounds and their
Use” (“Patent”).
The patent advances Theralase’s intellectual
property portfolio internationally strengthening the patent
portfolio around the Anti-Cancer Technology
(“ACT”) platform. The patent encompasses an
extensive library of PDCs, including Theralase’s lead PDC,
TLD-1433, approved by Health Canada to be evaluated in a Phase II
Non-Muscle Invasive Bladder Cancer (“NMIBC”)
clinical study (“Study II”).
The Mechanism of Action (“MOA”)
of the patented Theralase® PDCs involves selective localization of
the PDC inside the cancer cells of interest and then activating it
by laser light to produce highly reactive free radicals, such as,
singlet oxygen and Reactive Oxygen Species
(“ROS”), temporally and spatially to destroy the
cancer cells, with minimum impact on healthy cells.
This patent further strengthens the extensive
portfolio of patents already held by Theralase®. The Company is
focused on increasing shareholder value, by providing the Company
international patents to protect its unique technology, as the
Company moves closer towards commercialization.
Currently, Study II has successfully been
launched in 12 Clinical Study Sites (5 - Canadian and 7 – United
States) with 41 patients treated.
Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief
Executive Officer (“CEO”) and Chief Scientific
Officer (“CSO”), Theralase® stated that, “This
patent is strategic to opening up new international opportunities
for Theralase® by expanding its IP portfolio of medical laser and
oncology focused technologies internationally. Theralase®’s
long-term strategy is to commercialize the Anti-Cancer Therapy
(“ACT”) technology commencing with NMIBC and
expanding into Non-Small Cell Lung Cancer
(“NSCLC”), Glioblastoma Multiforme
(“GBM”) and other various cancer indications to
provide a safe, effective, and rapid alternative treatment option
for patients inflicted with these deadly diseases. The ability to
provide personalized treatment for cancer patients to “hunt and
destroy” their cancer and prevent its recurrence and progression,
all in a single or dual treatment, remains at the forefront of our
research and development objectives”.
About Study II
Study II utilizes the therapeutic dose of
TLD-1433 (0.70 mg/cm 2 ) activated by the proprietary
TLC-3200 medical laser system. Study II is focused on enrolling and
treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma
In-Situ (“CIS”) patients in up to 15 Clinical
Study Sites (“CSS”) located in Canada and the
United States.
Study II Objectives:
-
Primary - Efficacy (defined by CR) at any
point in time.
-
Secondary - Duration of CR (defined by
duration of CR lasting a minimum 360 days post-initial CR).
-
Tertiary - Safety measured by incidence and
severity of AEs Grade 4 or higher that do not resolve within 450
days post primary study treatment. (Grade 1 = Mild, Grade 2 =
Moderate, Grade 3 = Serious, Grade 4 = Life Threatening and Grade 5
= Death)
About TLD-1433
TLD-1433 is a patented PDC with over 10 years of
published peer-reviewed preclinical and clinical research and is
currently under investigation in Study II.
About Theralase® Technologies
Inc.
Theralase® is a clinical stage pharmaceutical
company dedicated to the research and development of light
activated compounds and their associated drug formulations with a
primary objective of efficacy and a secondary objective of safety
in the destruction of 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. Forward
looking statements may be identified by the use of the words
"may, "should",
"will", "anticipates",
"believes", "plans",
"expects", "estimate",
"potential for" and similar expressions including
statements related to the current expectations of Company's
management for future research, development and commercialization
of the Company’s Photo Dynamic Compounds and their drug
formulations, 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 a Phase II NMIBC clinical study
in a timely fashion to 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’s fails to comply with the term 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 successfully come to fruition, 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
Akanksha Dhingra, BAJPublic Relations and Investor Relations
Coordinatoradhingra@theralase.com416.699.LASE (5273) x 303
Kristina Hachey, CPAChief Financial
Officerkhachey@theralase.com416.699.LASE (5273) x 224
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