Theralase® Provides Corporate Update
Theralase® Provides Update on Upcoming Initiatives for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario – August 27, 2018
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
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 (“PDCs”) and their associated drug formulations 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.
This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s development and commercialization of the TLC-2000, including with respect to ongoing redesign work and regulatory clearance process for expanded claims and the Company’s development and commercialization strategy with respect to its Anti-Cancer Technology. 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 the Company to successfully complete the redesign work under the proposed timeframe and scope of work or at all, the availability of financing to advance the development of the TLC-2000, the ability of the Company to secure further regulatory clearances (including with respect to expanded claims) from Health Canada and/ or the FDA with respect to the TLC-2000 under the proposed timeframe and scope or at all, the ability of the Company to achieve wider commercial distribution of the TLC-2000, the ability of the Company to execute its strategy with respect to its Anti-Cancer Technology, the ability of the Company to secure further regulatory approvals from Health Canada and/ or the FDA for its NMBIC clinical studies and the ability of the Company to finalize development of, and successfully commercialize, its Anti-Cancer Technology. 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 news 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 Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information: