Theralase® Technologies Inc. (“
Theralase®” or the
“
Company”) (
TSXV: TLT)
(
OTCQB: TLTFF), a clinical stage pharmaceutical
company dedicated to the research and development of innovative
Anti-Cancer Therapy (“
ACT”) technologies intended
to safely and effectively destroy various cancers, bacteria and
viruses, while preserving patient Quality Of Life
(“
QOL”) announced today the launch of the seventh
US-based Clinical Study Site (“
CSS”);
specifically, the University of Chicago Medicine (“
UChicago
Medicine”). UChicago Medicine has successfully received
Institutional Review Board (“
IRB”) approval
allowing them to commence enrollment and treatment of patients in
Theralase®’s pivotal Phase II Non-Muscle Invasive Bladder Cancer
("
NMIBC") Clinical Study (“
Study
II”).
Study II is focused on the enrollment and
treatment of approximately 100 to 125 patients, who have been
previously diagnosed with Bacillus Calmette Guérin
("BCG")-Unresponsive Carcinoma In-Situ
("CIS") or who are intolerant to BCG therapy
("Study II").
The Company has successfully launched five CSSs
in Canada and 7 in the US for patient enrollment and treatment in
Study II.
UChicago Medicine, with a history dating to
1927, is a not-for-profit academic medical health system based on
the campus of the University of Chicago in Hyde Park, with
hospitals, outpatient clinics and physician practices located
throughout Chicago and its suburbs. UChicago Medicine translates
fundamental scientific discoveries into better care for their
patients and performs more clinical trials than any other hospital
in Illinois.
Dr. Piyush Agarwal, MD, Professor of Surgery and
Urology, Director, Bladder Cancer Program, Fellowship Director,
Urologic Oncology, at UChicago Medicine stated, “This technology
harnesses the power of near infrared light produced by a laser to
destroy localized bladder cancer cells that have not responded to
standard of care therapy such as BCG. It gives patients an option
to consider before bladder removal.”
Dr. Agarwal’s clinical and laboratory research
focuses primarily on bladder cancer, specifically BCG-Unresponsive
disease, the urinary microbiome, molecular targeted therapy and
immunotherapy. He has conducted several original,
investigator-initiated clinical studies and has presented his
research at national and international meetings. Dr. Agarwal has
served on the Food and Drug Administrations
(“FDA”) oncologic drug advisory committee and has
authored six book chapters and over 90 manuscripts.
The first US-based patient in Study II was
recently treated at Virginia Urology (“VU”) (
Richmond, Virginia).
VU has a long history of providing quality care
to the Greater Richmond metro area for over 75 years. VU prides
itself on its strong commitment to the community’s urological needs
by recruiting highly skilled physicians and using the latest
technology. VU is comprised of over 40 physicians that include
urologists and urogynecologists as well as physicians specializing
in the urologic aspect of anesthesiology, pathology, radiation
oncology, and radiology. Because VU has such diverse medical
professionals, they are able to provide the latest technologies
with their mission of providing the best possible care for each
patient.
To date, Study II has enrolled and provided the
primary study treatment for 20 patients (including three patients
from Phase Ib study treated at the Therapeutic Dose) for a total of
23 patients.
Shawn Shirazi, PhD, Chief Executive Officer of
Theralase®, stated, “It is exciting to see Theralase® clear another
hurdle by treating the first patient in the US and move one step
closer to achieving its next milestone of enrolling and treating
twenty-five patients in early 2021. Once completed, Theralase®
plans to submit the clinical assessment data on the first
twenty-five patients treated in Study II to the FDA for
consideration of Break Through Designation (“BTD”)
status.”
About Theralase® Technologies
Inc.Theralase® is a clinical stage pharmaceutical company
dedicated to the research and development of innovative Anti-Cancer
Therapy (“ACT”) technologies intended to safely
and effectively destroy various cancers, bacteria and viruses,
while preserving patient Quality Of Life
(“QOL”).
Additional information is available at
www.theralase.com and www.sedar.com
Forward Looking Statement:
This news release contains "forward-looking
statements" which reflect the current expectations of the Company's
management for future growth, results of operations, performance,
business prospects and opportunities. Such statements include, but
are not limited to, statements regarding the Company's proposed
development plans with respect to Anti-Cancer Therapy technologies.
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 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 the
Company to: adequately fund, secure the requisite regulatory
approvals to commence and successfully complete a Phase II NMIBC
clinical study in a timely fashion and implement its
commercialization plans. Many factors could cause the Company'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 Company 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 Company cannot
assure prospective investors that actual results, performance or
achievements will be consistent with these forward-looking
statements. The Company disclaims any intention or obligation to
revise 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 Exchange) accepts responsibility for the adequacy or
accuracy of this release.
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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