Theralase® Technologies Inc. (“
Theralase” or the
“
Company”) (
TSXV: TLT)
(
OTCQB: TLTFF), a clinical stage pharmaceutical
company dedicated to the research and development of light
activated Photo Dynamic Compounds (“
PDC”) and
their associated drug formulations intended to safely and
effectively destroy various cancers is pleased to announce that
Theralase®’s research, published in Translational Biophotonics
(“
TBIO”), is one of the top 10 most downloaded
papers in TBIO, amongst work published between January 1, 2019 to
December 31, 2020.
According to the TBIO’s website, TBIO is an
international peer-reviewed, open access journal dedicated to
bridging the gap in translating medical photonic research into
clinical practice. TBIO serves as a platform for translating
photonic methods and technologies in all medical areas to solve
unmet medical needs in diagnosis and therapy.
The symbiosis between photonics and medicine
serves as the bridge in integrating translational research into
clinical practice.
The Theralase® sponsored research entitled,
“Evaluation of a Ruthenium coordination complex as photosensitizer
for Photo Dynamic Therapy (“PDT”) of bladder
cancer: Cellular response, tissue selectivity and in vivo response”
(“Publication”) demonstrated that the combination
of TLD-1433 activated by green laser light resulted in the
selective and effective destruction of various cancer cell lines
both in-vitro and in-vivo, including the complete eradication of
urothelial bladder tumours along with protecting normal bladder
muscle function.
The publication can be accessed online at:
Evaluation of a Ruthenium coordination complex
as photosensitizer for PDT of bladder cancer: Cellular response,
tissue selectivity and in vivo response - Lilge - 2020 -
Translational Biophotonics - Wiley Online Library
In conclusion, the Publication stated that,
“Combination of TLD-1433 instillation and the use of green PDT
activation light results in a steep PDT gradient providing one
avenue to protect normal muscle function. The high selective uptake
of TLD-1433 is very favorable to compensate for heterogeneities in
the bladder wall irradiance, and the absence of visible damage to
the muscle layers also opens an avenue for the treatment of Muscle
Invasive Bladder Cancer (“MIBC”) in addition to
targeting Non-Muscle Invasive Bladder Cancer
(“NMIBC”).”
Lothar Lilge Ph.D., senior staff scientist, UHN
stated "In my lab, TLD-1433 based PDT has been proven in numerous
in-vitro and in-vivo studies to be an effective and viable
treatment for the destruction of numerous human and animal cancers.
Upon irradiation with laser light, TLD-1433 produces highly
aggressive Reactive Oxygen Species (“ROS”) and
hydroxyl radicals, spatially and temporally, which have been proven
to be deadly to cancer cells. I am humbled that research, where I
was the lead author, became one of the top 10 downloaded papers
from TBIO in the 12 months following its publication. The research
which I co-authored has now successfully translated from the
laboratory bench to clinical studies: firstly, in the successfully
completed Theralase® Phase Ib Non-Muscle Invasive Bladder Cancer
(“NMIBC”) clinical study (safety and efficacy
study) and secondly, in the pivotal Theralase® Phase II NMIBC
clinical study, currently in progress. I am excited to see, from
the preliminary clinical data Theralase® has accumulated to date,
that Theralase® is advancing well to achieve the primary,
secondary and tertiary Study II objectives”
Dr. Arkady Mandel M.D., Ph.D., D.Sc., Interim
Chief Executive Officer and Chief Scientific Officer of Theralase®
stated, “This is another milestone of excellence achieved by
Theralase®. These pre-clinical results led a logical progression to
our successfully completed Phase Ib NMIBC clinical study, which
demonstrated the safety, pharmacokinetics and efficacy in a first
in-human clinical study. The success in the Phase Ib NMIBC clinical
study has led to the impressive preliminary results demonstrated in
the Phase II NMIBC clinical study, focused primarily on efficacy
and secondarily on safety. In the future, I foresee great potential
for Theralase® Anti-Cancer Therapy (“ACT”) to
deliver a safe and effective anti-cancer treatment for numerous
cancer indications with high unmet needs."
About Study IThe Study’s
primary objective was safety and tolerability of PDT, with a
secondary objective of pharmacokinetics ((drug evacuation from the
body)) and a tertiary objective of efficacy (Complete Response
(“CR”) primarily at 90 days and secondarily at 180
days for patients treated at the maximum recommended starting dose
(0.35 mg/cm2) and the therapeutic dose (0.70 mg/cm2)).
Patients who were treated at the therapeutic dose, consented to be
followed clinically for 18 months, post initial treatment.
About Study IIStudy 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-1433TLD-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 StatementsThis 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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