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 safely and effectively
destroy various cancers, bacteria and viruses, announced today that
its Phase II Bacillus Calmette Guerin (“
BCG”)
Unresponsive Non-Muscle Invasive Bladder Cancer
(“
NMIBC”) Carcinoma In-Situ
(“
CIS”) clinical study (“
Study
II”) (Interim) data has been accepted by the American
Urology Association (“
AUA”) for a moderated poster
presentation at its annual meeting.
The AUA annual meeting will take place between
April 28th to May 1st, 2023 in Chicago, Illinois with the poster
presented for general viewing and discussion within one of the
moderated poster sessions, during the AUA annual meeting.
The poster titled: “A Phase II Clinical Study of Intravesical
Photo Dynamic Therapy (“PDT”) in Patients with
BCG-Unresponsive NMIBC (interim analysis)” will be presented by the
lead author, Girish Kulkarni M.D., Ph.D., FRCSC, Divisions of
Urology and Surgical Oncology, Department of Surgery, Princess
Margaret Cancer Centre, University Health Network, Professor,
University of Toronto, (Toronto, Ontario, Canada).
The poster will include interim clinical data and analysis
collected through the enrollment and treatment of patients at all
Canadian and US clinical study site by their respective principal
investigators for Study II.
Arkady Mandel MD, Ph.D., D.Sc., Interim Chief
Executive Officer and Chief Scientific Officer, Theralase® stated,
“I am delighted that Theralase® will have the opportunity to
showcase its latest reported interim clinical data and analysis for
Study II at the AUA annual meeting to leading uro-oncologists from
around the world. The interim analysis of the clinical data
collected from Study II to date supports that early results show
complete response rates in 53% of patients evaluated at 90 days and
28 % of patients evaluated at 450 days. Based on the clinical data
collected to date, PDT could represent a viable treatment option
with an acceptable safety profile.”
About AUAFounded in 1902, with
more than 20,000 members worldwide, the AUA is a premier urologic
association, providing invaluable support to the urologic community
with the mission is to promote the highest standards of
urological clinical care through education, research and the
formulation of health care policy.
About Study IIStudy II utilizes
the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the
proprietary TLC-3200 medical laser system. Study II is focused on
enrolling and treating approximately 100 to 125 BCG-Unresponsive
NMIBC CIS patients in up to 20 clinical study sites located in
Canada and the United States.
About TLD-1433TLD-1433 is a
patented PDC with 12 years of published peer reviewed preclinical
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
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.
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:Kristina Hachey, CPAChief
Financial Officer1.866.THE.LASE (843.5273)416.699.LASE (5273)
khachey@theralase.comwww.theralase.com
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