RE:NEWS Fifth study site UWH 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."