Theralase Advances its Pivotal Phase II Non-Muscle Invasive Bladder Cancer Study with a New Clinical Study Site in Nova Scotia
Toronto, Ontario – February 25, 2020, 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 Nova Scotia Health Authority (“NSHA”) Research Ethics Board (“REB”) has approved the commencement of a Pivotal 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”).
The Nova Scotia provincial cancer rates are among the highest in Canada. It is estimated for 2019 in Nova Scotia that 6,700 people were diagnosed with cancer, and 2,900 people died of cancer1 with bladder cancer cases counting for approximately 5% of cancer diagnosis.2
The NSHA institution is affiliated with the Urology Department at Dalhousie (“UDD”) University of Medicine, an innovative leader in urological oncology research. UDD evaluates new technologies designed to improve the lives of people suffering from urological cancers. Each year, more than 300 people are diagnosed with bladder cancer and seek attention in Nova Scotia.2 UDD doctors have extensive experience providing quality of care for bladder cancer patients while maintaining an active research role to enhance overall patient care.
Dr. Ricardo Rendon, MD, FRCSC, Professor in the Department of Urology and Director of Clinical Trial of Dalhousie University in Halifax stated that “We are excited to work with Theralase for the NMIBC clinical trial. Tackling cancer is a crucial topic and a priority for this region, and I am pleased that NSHA is able to contribute to the growth of innovative cancer research by taking part in this leading Pivotal PhotoDynamic Therapy (“PDT”) study.”
With the addition of NSHA, the Company now has four sites open for patient enrollment and treatment, specifically, NSHA, London Health Science Centre (“LHSC”), University Health Network (“UHN”) and McGill University Health Centre (“MUHC”). In addition, the Company has approximately 16 clinical study sites located in Canada and the US that are at various stages of the on-boarding process. The Company is strategically targeting 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.
Shawn Shirazi, Ph.D., CEO of Theralase, stated that “I am pleased to announce the addition of NSHA and Dr. Rendon as Principal Investigator. Dr. Rendon is considered an expert in the field with a clinical focus on all areas of uro-oncology. To date, 10 patients have been treated, which represents a 10% completion rate of patient enrollment, and about a 50% completion rate in relation to the interim analysis milestone set at treating 20 to 25 patients. By continuing to advance Study II, we hope to bring this treatment to all Canadian patients suffering from this disease and look forward to starting our clinical study in the US, subject to regulatory approval.”
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. To date, 4 clinical study sites are active for enrollment and 10 patients have been treated in the Study II.
In 2020, an estimated 81,400 adults (62,100 men and 19,300 women) will be newly diagnosed with bladder cancer in the United States. Among men, bladder cancer is the fourth most common cancer. It is estimated that 17,980 deaths (13,050 men and 4,930 women) from this disease will occur in 2020.3 The bladder cancer market is expected to triple in size to around $1.1 billion by 2025.4
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 Canadian Cancer Statistics Publication, Nova Scotia cancer statistics at a glance. https://www.cancer.ca/en/cancer-information/cancer-101/canadian-cancer-statistics-publication/?region=ns. Accessed January 29, 2020.
2 Canadian Cancer Statistics – 2019. http://www.cancer.ca/~/media/cancer.ca/CW/publications/Canadian%20Cancer%20Statistics/Canadian-Cancer-Statistics-2019-EN.pdf. Accessed January 29, 2020.
3 Key Statistics for Bladder Cancer. https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html. Accessed January 29, 2020.
4 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. 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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