Theralase Launches Fifth Clinical Study Site in the US for Phase II Bladder Cancer Clinical Study
Theralase Technologies Inc. (TSXV:TLT, OTCQB:TLTFF) announced that the University of Wisconsin Health-Madison received IRB approval for a pivotal Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) clinical study. This study targets patients with BCG-Unresponsive Carcinoma In-Situ. The approval marks the fifth clinical site in the US for this study, with another pending. Theralase aims to treat 25 patients in 2021 to seek Breakthrough Designation Approval, with 75-100 additional patients planned for 2021/2022.
- IRB approval received for Phase II NMIBC clinical study.
- Fifth clinical study site launched in the US.
- Aiming for Breakthrough Designation Approval after treating 25 patients in early 2021.
- None.
TORONTO, ON / ACCESSWIRE / February 24, 2021 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that University of Wisconsin Health-Madison ("UWH") has received site Institutional Review Board ("IRB") approval to commence a pivotal Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study to enroll and treat patients with Bacillus Calmette Guerin("BCG")-Unresponsive Carcinoma In-Situ ("CIS") or who are intolerant to BCG Therapy ("Study II").
This marks the fifth US clinical site that has successfully obtained site IRB approval through a central IRB. One additional US clinical study site is pending IRB site approval in 1Q2021.
The Department of Urology at UWH is a leading academic program offering comprehensive multidisciplinary urologic care in conjunction with innovative research, teaching, and learning opportunities. The University of Wisconsin Hospitals and Clinics are ranked #14 in the nation for urology, according to the 2019-2020 U.S. News & World Report's "Best Hospitals" rankings.
Dr. Kyle Richard, MD, FACS, Chief of Urology, William S. Middleton Memorial VA hospital; Assistant Professor, College of Health Sciences University of Wisconsin-Milwaukee stated "We are excited to work with Theralase for this early-stage bladder cancer clinical study. Tackling cancer is a crucial topic and a priority for this region, and I am pleased that UWH is able to contribute to the growth of innovative cancer research by taking part in this pivotal Photo Dynamic Therapy ("PDT") study".
To date 15 patients have been treated in Study II. The Company has now launched 5 Clinical Study Sites ("CSS") in Canada and 5 in the US for patient enrollment and treatment under Study II clinical study guideline.
Shawn Shirazi, PhD, Chief Executive Officer, Theralase®, stated, "Each CSS Theralase launches for Study II will aid in our objective of enrolling and treating 10 patients in early 2021 to achieve a total of 25 patients for potential Breakthrough Designation Approval and approximately 75 to 100 additional patients in 2021 / 2022."
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, bacteria and viruses.
Additional information is available at www.theralase.com and www.sedar.com
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 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 commercialization 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 Exchange) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
1.866.THE.LASE (843-5273)
416-699-LASE (5273)
www.theralase.com
Kristina Hachey
Chief Financial Officer
khachey@theralase.com
416-699-LASE (5273) x 224
SOURCE: Theralase® Technologies Inc.
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FAQ
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