London Health Sciences Centre Launches as Newest Clinical Study Site for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario – October 07, 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 (“PDC”) and associated drug formulations, announced that London Health Sciences Centre (“LHSC”) Research Ethics Board (“REB”) has approved the commencement of a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study to enroll and treat patients who present with Carcinoma In-Situ (“CIS”) and who are considered Bacillus Calmette-Guerin (“BCG”)-Unresponsive or are intolerant to BCG Therapy (“Study II”).
LHSC is recognized as one of Canada’s leading cancer research centres ranking, in the top ten of Canada’s research hospitals. LHSC’s research institute is affiliated with the University of Western Ontario and is responsible for training the next generation of medical professionals, while leading Ontario research into the latest medical technologies.
Dr. Joseph Chin, MD, FRSC, Professor of Urology & Oncology, at the University of Western located in London Ontario, stated that “Theralase’s Phase II NMIBC Clinical Study, utilizing their ground-breaking technology, provides a significant number of patients with bladder cancer, who have essentially exhausted all of their management options, short of more invasive surgery with another chance at a cure and preservation of their bladder.”
With the addition of LHSC, the Company now has three sites open for patient enrollment and treatment; specifically, LHSC, University Health Network (“UHN”) and McGill University Health Centre (“MUHC”). All sites are actively recruiting and screening new patients for enrollment in Study II. In addition, the Company has approximately six clinical study sites located in Canada and the US that are at various stages of the on-boarding process. The Company is specifically targeting strategic clinical sites throughout Canada and the US (subject to FDA Investigational New Drug (“IND”) approval) that serve large populations or have the demographics to support patient enrollment and treatment. The Company anticipates that patient enrollment and treatment will escalate rapidly with the increased momentum as it launches additional clinical study sites, as UHN has now treated its second patient.
Shawn Shirazi, Ph.D., CEO – Drug Division, Theralase stated that, “I’m delighted that a high-quality organization such as LHSC has elected to join the Theralase team as the third Canadian study site that can enroll and treat patients with NMIBC, who are BCG-Unresponsive. We are working towards onboarding the rest of the Canadian study sites for Study II by the end of the year and hope to bring some US study sites on board before year end. The recent news from both patient five and six cancer-free status at 540 days from the Phase Ib study, which represents a 67% Complete Response (“CR”) rate, supports the strong contention that the TLD-1433 Anti-Cancer Technology (“ACT”) platform has the potential to be a viable treatment solution for CIS NMIBC BCG-Unresponsive patients, if the Company is able to duplicate the efficacy results observed in the Phase Ib clinical study.”
About Study II
The Phase II NMIBC Clinical Study utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433, focusing on the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with 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 .
In 2019, an estimated 80,470 adults (61,700 men and 18,770 women) were diagnosed with bladder cancer in the United States. Among men, bladder cancer is the fourth most common cancer. It is estimated that 17,670 deaths (12,870 men and 4,800 women) from this disease will occur in 2019. Among men, bladder cancer is the eighth most common cause of cancer death.1 The bladder cancer market is expected to triple in size to around $1.1 billion by 2025.2
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.
1 Cancer Facts and Figures 2019. American Cancer Society. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2019.html. Accessed January 14, 2019.
2 Bladder cancer market size to more than triple to over $1.1 billion by 2025. (2017). Retrieved 14 August 2019, from https://www.globaldata.com/bladder-cancer-market-size-triple-1-1-billion-2025/
Forward Looking Statement:
This news release contains “forward-looking statements” which reflect the current expectations of the Company’s Management for future growth, results of operations, performance, 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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