Theralase® Provides Update on Upcoming Initiatives for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario (FSCwire) - Theralase Technologies Inc.
(“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a
clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds
(“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers has
provided a corporate update on the Phase II for the Non-Muscle Invasive Bladder Cancer (“NMIBC”) Clinical
Study.
Photo Dynamic Therapy (“PDT”) utilizing the Company’s lead drug, TLD-1433, has met all expectations of the
Company in the successfully completed Phase Ib NMIBC Clinical Study.
In the Phase Ib study all 6 patients enrolled and treated (3 at the Maximum Recommended Starting Dose
(“MRSD”) (0.35 mg/cm2) and 3 at the Therapeutic Dose (0.70 mg/cm2)) achieved both the
primary (safety and tolerability as measured by Adverse Events (“AE”)) and secondary (pharmacokinetics, as
measured by PDC remaining in urine and blood) endpoints.
All 3 patients (patients 4, 5 and 6) treated with the Therapeutic Dose achieved a Complete Response (“CR”) at
90 days after PDT. Patients 5 and 6 achieved a CR at 180 days and continue to exhibit a CR. Patient 4 was found to have
progressed to metastatic disease after 90 days and was removed from the follow up evaluation. This metastatic progression of
disease in patient 4 was unrelated to TLD-1433 PDT.
These results compelled the independent Medical and Scientific Advisory Board (“MSAB”) to recommend to the
Company, the early termination of the Study due to achievement of the primary and secondary endpoints. The MSAB also recommended
that the clinical data collected from the first three patients treated at the MRSD and the three patients treated at the
Therapeutic Dose were sufficient to support the conclusion that the Study had successfully achieved the Study’s primary and
secondary endpoints and had adequately addressed the Study’s scientific, technical and clinical questions, as per the approved
Study design and clinical protocol. The MSAB recommendation to the Company was to terminate the Study based on the six patients
treated to date and suggested that the Company pursue a pivotal Phase II NMIBC clinical study approval with Health Canada and the
FDA with efficacy as the primary endpoint.
Patient 5 and 6 in the Phase Ib study, presented with stage T1 High Grade and Carcinoma-In-Situ (“CIS”)
NMIBC, respectively, prior to the PDT treatment and regardless of the treatment procedure performed (i.e.: Trans-Urethral
Resection of the Bladder Tumour (“TURBT”) and/or Bacillus Calmette Guérin (“BCG”)) had done so
for the last 4 and 5 years, respectively).
The 180 day CR of their disease to Theralase’s PDT marks a significant event for both the Company and the patients.
The Phase II NMIBC Clinical Study is currently under Health Canada review and is expected to be submitted to the Food and Drug
Administration for review in September 2018.
The Company will work with both Canadian and US regulatory authorities to address any questions they may have about the Phase
II clinical study design and expect to receive the requisite approvals to commence the Phase II clinical study in both countries
in late 2018 / early 2019.
The Phase II clinical study is anticipated to involve the recruitment, treatment and follow-up of 100 patients providing them
two Theralase PDT treatments, one at Day 0 and one at Day 180.
The enrollment, treatment and follow-up of these 100 patients is expected to involve 15 to 25 clinical sites in Canada, the
US, and internationally, and is expected to take 3 years to complete.
If the initial data in the Phase II clinical study is favourable compared to standard of care, then early adoption of the
technology for commercial application is possible, subject to approval by the requisite regulatory authority.
Michael Jewett, MD, FRCSC, FACS, Professor of Surgery (Urology) at the University of Toronto and the Chairman of
Theralase’s MSAB stated that, “The lack of significant adverse events and early efficacy signal with the six month CR data from
the Phase Ib clinical study is encouraging and reinforces our strong support for conducting the Phase II NMIBC clinical study.
Theralase’s PDT technology platform may offer a new treatment option for NMIBC patients, who have exhausted all other available
treatment options. In contrast to most other areas in cancer therapy, there has not been a significant treatment advance for CIS
and/or high-grade NMIBC in decades. TLD-1433 PDT is a unique and innovative approach, using a targeted, patient specific drug and
light delivery system. I believe the Theralase PDT treatment will provide NMIBC BCG-Unresponsive patients (patients who have
failed the standard of care treatment of TURBT and BCG) with new hope and an alternative for staving off life-altering bladder
removal surgery.”
About Theralase Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo
Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers. The
Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser
technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint
conditions.
Additional information is available at www.theralase.com and www.sedar.com .
This news release contains "forward-looking statements" which reflect the current expectations of
management of the Corporation’s future growth, results of operations, performance and business prospects and opportunities. Such
statements include, but are not limited to, statements regarding Theralase’s proposed development plans with respect to Photo
Dynamic Compounds and their drug formulations. 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 current 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 Theralase to: successfully fund and complete
a Phase II NMIBC clinical study, secure the requisite regulatory approvals to commence a
Phase II NMIBC clinical study and implement its development plans. Many factors
could cause the Corporation’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 Corporation 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 Corporation cannot assure prospective investors that actual results, performance or achievements will be
consistent with these forward-looking statements. The Corporation 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 Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
info@theralase.com
www.theralase.com
To view the original release, please click here
Source: Theralase Technologies Inc. (TSX Venture:TLT, OTCQX:TLTFF, FWB:TTX)
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