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 Phase Ib Non-Muscle Invasive Bladder Cancer
(“
NMIBC”) clinical study
(“
Study”) has been peer reviewed and published in
the European Urology Open Science (“
EUOS”) Journal
, Volume 41, July 2022.
According to EUOS’s website, EUOS is dedicated
to the publication of high quality, innovative research that will
benefit patients with urological conditions. EUOS covers
research in the urological field, including clinical, basic and
translational research.
The publication can be accessed online at no charge at:
https://www.sciencedirect.com/science/article/pii/S2666168322005900
The publication states, “Despite efforts to
bring new treatment strategies forward for Bacillus Calmette Guérin
(“BCG”)-Unresponsive NMIBC, a clear consensus
for a standard treatment other than radical
cystectomy has yet to be established. An effective therapy
that provides a high initial and durable responses remains an unmet
need.”
The publication is entitled, “A Phase 1b
Clinical Study of Intravesical Photodynamic Therapy in Patients
with Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive
Bladder Cancer” and states, “Although limited by the small
sample size typically inherent in phase 1 trials, we feel that the
photosensitizer TLD-1433 and the delivery device TLC-3200 hold
promise for the treatment of NMIBC. In this study, Photo
Dynamic Therapy (“PDT”) was well tolerated
and demonstrated safety and potential efficacy, thus warranting
further study.”
As a result, the Medical and Scientific Advisory
Board (“MSAB”) unanimously agreed that Theralase®
should further investigate PDT in a multi-site, pivotal Phase II
NMIBC Clinical Study (“Study II”). Study II is
currently underway at 5 Clinical Study Sites
(“CSS”) in Canada and 7 CSSs in the United States,
with 41 patients treated to date.
Girish Kulkarni, M.D., Ph.D., lead principal
investigator of the Study at the Divisions of Urology and Surgical
Oncology, Department of Surgery, Princess Margaret Cancer Centre,
University Health Network, University of Toronto, Toronto, Ontario,
Canada (“UHN”) stated, "I am delighted that the
high-quality research conducted at UHN, in conjunction with
Theralase®, was successful, in this challenging patient population,
both for safety and potential efficacy. Patients with
BCG-Unresponsive NMIBC are a difficult patient population to treat
since they have unfortunately failed the standard of care, BCG.
Many also failed other investigational therapies prior to being
treated with Theralase®’s PDT. The clinical data that we collected
was robust and clinically relevant. I am fully supportive of the
multi-site Phase II NMIBC clinical study, currently in progress, to
further investigate the role of PDT in BCG-Unresponsive NMIBC.”
Dr. Arkady Mandel M.D., Ph.D., D.Sc., Interim
Chief Executive Officer and Chief Scientific Officer of Theralase®
stated, “The Company is very pleased to share the Study clinical
data that has been peer-reviewed and published in EUOS. Indeed, the
publication of clinical results in a peer reviewed journal like
EUOS validates the quality of the Theralase® research and the
professionalism of the clinical study team, who conducted it. As a
direct result of the success of this initial Study, Theralase®
elected to undertake Study II, which I am happy to report is
proceeding well. I am encouraged by the clinical data generated to
date with intravesical TLD-1433, activated by laser light therapy,
as I believe Theralase®’s PDT is a viable alternative for the
BCG-Unresponsive NMIBC patient population, although significant
data is still pending. The ongoing analysis of the patients
supports that up to 50% of evaluable patients (patients who have
been clinically assessed by the principal investigators at study
visits and whose response to a treatment can be measured because
enough information has been collected) have achieved the primary
study objective. We are grateful for the ongoing support to all
clinical and technical personnel involved in the successful
completion of the Study and in the strong clinical data collected
to date for Study II. Based on the strength of the clinical data
collected and the consistently high safety and efficacy profile of
Theralase®’s PDT, I am confident that TLD-1433-based therapy has
the potential to become the next gold-standard in the treatment of
BCG-Unresponsive patients.”
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 (CR primarily at 90 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/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 Carcinoma In-Situ (“CIS”) patients in up to
15 CSSs 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 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
Kristina Hachey, CPAChief Financial
Officerkhachey@theralase.com416.699.LASE (5273) x 224
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