Theralase® Achieves Exploratory Efficacy Endpoint in Phase Ib Non-Muscle Invasive Bladder Cancer Clinical Study for Patients Five and Six
Patient Five and Six Demonstrate No Clinical Evidence of NMIBC at 180 Day Cystoscopy Analysis
Company Successfully Completes 180 days Follow Up of the Phase Ib Study and Plans Regulatory Filings to Commence a Phase II Clinical Study that May Lead to Commercialization of the TLD-1433 Anti-Cancer Technology for Non-Muscle Invasive Bladder Cancer (“NMIBC”)
Toronto, Ontario – August 13, 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 an update on patient six, enrolled and treated in the recently completed Phase Ib NMIBC clinical study (“Study”).
The Study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and an exploratory endpoint of efficacy.
The exploratory outcome endpoint was defined as Recurrence-Free Survival (“RFS”), which is the interval from the day of the treatment to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumour growth (i.e. any biopsy-confirmed new or recurrent tumour), evaluated primarily at ninety (90) days for the last three patients treated at the Therapeutic Dose (0.70 mg/cm2) and secondarily one hundred and eighty (180) days post treatment.
Patient number six was treated with the same optimized clinical treatment procedure as patient number five. The treatment was well tolerated by both patients, who demonstrated no tumour recurrence or presence of disease at the 180 day clinical and cystoscopy assessment.
This marks the 2nd patient treated at the optimized clinical treatment procedure that has met Study endpoints demonstrating achievement of the primary, secondary and exploratory endpoints at 180 days post treatment and marks a new achievement for the Company.
Theralase’s Anti-Cancer Treatment involves the instillation of a water-based solution of Theralase’s lead anti-cancer PDC, TLD-1433, via a catheter inserted through the urethra into the bladder of the patient, to allow the PDC to be preferentially absorbed by NMIBC tumours. The bladder is then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, known as a Laser Emitter emits laser light to activate TLD-1433, while a Dosimetry Cage detects the emitted laser light, used for patient safety and efficacy. Both devices are inserted through the cystoscope, with a sole purpose of activating the absorbed PDC to destroy the NMIBC tumours.
Arkady Mandel, M.D., Ph.D., D. Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated, “This is an exciting milestone for our Company, which further solidifies the power of Theralase’s Anti-Cancer Technology. We look forward to advancing the optimized treatment procedure throughout our planned Phase II study and eventually commercialization, if these same results are confirmed in the Phase II NMIBC clinical study. The Theralase Anti-Cancer Technology may very well be the next gold standard in the treatment of NMIBC. Due to the Anti-Cancer Technology’s ability to adapt to different cancerous targets and pending the successful regulatory approval for the Phase II NMIBC Clinical Study, Theralase intends to further develop this this technology in the treatment of numerous cancer targets.”
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.
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