Patient Six Cancer-Free Eighteen Months After Single Anti-Cancer Treatment
Toronto, Ontario – September 30, 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 is pleased to announce that patient six, 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.
Patient six has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 90, 180, 270, 360 and now 540 days post treatment clinical cystoscopy assessment and urine cytology, marking a new milestone for the Company.
Shawn Shirazi, Ph.D., Chief Executive Officer – Drug Division, Theralase stated “I’m excited to share the current cancer-free status of patient 6 which further validates that a single treatment of Theralase’s PhotoDynamic Therapy (“PDT”) can lead to a duration of Complete Response (“CR”) at 540 days post treatment for patients presenting with Bacillus Calmette Guérin (“BCG”)-Unresponsive NMIBC. If the Company is able to achieve similar efficacy results in CR rate and duration on an interim analysis – after approximately the first 20 or 25 patients enrolled and treated – we may have the opportunity to meet with the FDA and review the results, with a focus on obtaining accelerated approval for our Anti-Cancer therapy technology.”
Theralase has initiated a Phase II NMIBC clinical study (“Study II”), treating the first patient at University Health Network (“UHN”) in Toronto. Additionally, McGill University Health Center has finalized their agreement for Study II and has commenced screening and enrolling patients.
Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase stated “Patient 5 and 6 achieving CR at 18 months is a significant event for the Company, supporting the fact that Theralase’s TLD-1433 therapy can make a significant difference in a patient’s quality of life with a single treatment procedure. Moreover, our technology is multi-faceted and able to be adapted to additional cancer indications if successfully validated in independent clinical studies. The Company expects to investigate the commencement of an additional Phase Ib clinical study for a new cancer indication after Study II is well underway.”
About the Study:
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 achievements of the primary, secondary and exploratory endpoints at 90 and 180 days, when treated with the Therapeutic Dose (0.70 mg/cm2).
About Study II:
The Phase II NMIBC Clinical Study will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433, focusing on the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”) in approximately 20 clinical study sites located in Canada and the US. Study II will have a primary endpoint of efficacy (measured by CR) at any point in time, a secondary endpoint of duration of CR at approximately 360 days post-initial treatment and a tertiary endpoint of safety measured by incidence and severity of adverse events grade 4 or higher that do not resolve within 360 days post-initial treatment .
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.
Forward Looking Statement:
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.
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:
Shushu Feng, Investor Relations & Public Relations Coordinator