Patient Five Cancer-Free Eighteen Months After Single Anti-Cancer Treatment
Toronto, Ontario – July 31, 2019, 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 (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers reports that patient five, enrolled and treated in the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 540 day clinical and cystoscopy assessment.
The Study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy, primarily at 90 days and secondarily at 180 days post treatment.
The Study was successfully completed with patient five and six demonstrating achievement of the primary, secondary and exploratory endpoints at 90 and 180 days, when treated with the Therapeutic Dose.
Patient five has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 90, 180, 270, 360 and now 540 days post treatment clinical and cystoscopy assessment, marking a new achievement for the Company.
Patient five and six were enrolled and treated in the Study at the Therapeutic Dose (0.70 mg/cm2). Theralase’s Anti-Cancer Treatment involved the intravesical 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 was 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, comprising a Laser Emitter used to emit laser light and a proprietary Dosimetry System used to detect laser light, were then used to activate TLD-1433 resident in the NMIBC tumours.
Shawn Shirazi, Ph.D., Chief Executive Officer – Drug Division of Theralase® stated, “Today, we received additional evidence that even a single treatment with Theralase’s Photo Dynamic Therapy (“PDT”) is able to lead to a duration of Complete Response (“CR”) at 540 days post treatment for patients presenting with Bacillus Calmette Guérin (“BCG”)-Unresponsive NMIBC. This provides further support of the enormous opportunity that awaits Theralase in the treatment of NMIBC. If we are able to obtain similar efficacy results in CR rate and Duration in a larger patient population, through the Phase II NMIBC clinical study, then the Theralase Anti-Cancer Technology has the potential to be the next standard in the treatment of NMIBC. We are extremely excited and encouraged by this recent data demonstrating that BCG-Unresponsive NMIBC patients, who refused or were ineligible to undergo a radical cystectomy (surgical removal of bladder) have remained cancer free at 360 and now up to 540 days post treatment. Theralase’s TLD-1433 Photo Dynamic Therapy (“PDT”) may provide sustainable and comprehensive benefit to people diagnosed with NMIBC and the Company will be providing updates on the Phase II NMIBC clinical study as patients are enrolled and treated. The Theralase Anti-Cancer Technology is also multi-faceted, in that the technology is able to be adapted to the treatment of additional cancer indications if successfully validated in independent clinical studies. The Company plans to investigate the commencement of an additional Phase Ib clinical study for a new cancer indication after the Phase II clinical study is well underway.”
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.
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 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 the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. 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 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. 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.
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