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 clinical study (“
Study II”) interim
data was recently presented at the American Society of Clinical
Oncology (“
ASCO”) Genito Urinary
(“
GU”) Cancer Symposium via a moderated poster
presentation.
Study II has been designed to treat patients
diagnosed with Bacillus Calmette-Guérin
(“BCG”)-Unresponsive, Non-Muscle Invasive Bladder
Cancer (“NMIBC”) Carcinoma In-Situ
(“CIS”) (with or without resected papillary Ta/T1
disease) with a patented investigational study drug (TLD-1433)
(Trade Name: Ruvidar™), a ruthenium based PDC intravesically
instilled into a patient’s bladder, then subsequently activated by
a proprietary investigational study device (TLC-3200), a green (520
nm) laser system equipped with fiber-optic light emitters and
detectors.
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), lead principal
investigator of Study II stated, “Patients with BCG-Unresponsive
CIS NMIBC have historically had limited treatment options other
than bladder removal surgery to deal with this disease. I am
encouraged by the positive interim results of the light-activated,
intravesical study drug TLD-1433 (Trade Name: Ruvidar) currently
under investigation by Theralase® in Study II. 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 presented to date, Rudivar could
represent a viable treatment option with an acceptable safety
profile. I look forward to enrolling and treating additional
patients, alongside the other clinical study sites involved in
Study II, to complete this study’s enrollment.”
Arkady Mandel MD, Ph.D., D.Sc., Interim Chief
Executive Officer and Chief Scientific Officer, Theralase® stated,
“The high complete response rates and duration of this complete
response without serious adverse events, directly related to the
study drug or study device, indicates that intravesical Ruvidar™ is
a promising alternative to existing therapies and compares
favorably to other approved therapies; including: valrubicin,
pembrolizumab and Adstiladrin®. Ruvidar™, as an intravesical
monotherapy, has the potential to be introduced into mainstream
medical practice, subject to regulatory approval, based on its one
to two treatment methodology, high efficacy and high safety
profile. One day we hope that Ruvidar™ will become the
organ-sparing solution that is a game-changer for both patients and
physicians.”
The poster presented at the ASCO GU Cancer
Symposium can be found on the Company’s website
at www.theralase.com/ASCO_Poster.
About ASCOFounded in 1964, the
American Society of Clinical Oncology is the world's leading
professional organization for physicians and oncology professionals
caring for people with cancer.
About Study IIStudy II utilizes
the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the
proprietary TLC-3200 (90 J/cm2) 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-1433
(Ruvidar™)TLD-1433 is a patented PDC with
12 years of published peer reviewed preclinical research and is
currently under investigation in Study II.
The trade name Ruvidar was selected by the
Company, as Ru is the element symbol for Ruthenium, a rare
transition metal belonging to the platinum group, which the
Theralase® PDC is based upon, vita is Latin for life and dar is
Russian for gift; hence, roughly translated, “Ruthenium, the gift
of life”.
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) x224416.699.LASE (5273)
x224khachey@theralase.comwww.theralase.com
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