RE:Fourth site!! Toronto, Ontario – January 27, 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 Carolina Urologic Research Center (“CURC”) 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 fourth US clinical site that has obtained site IRB approval through a central IRB. There are 2 additional US clinical study sites that are expected to receive site IRB approval in 1Q2021.
CURC has been recognized both nationally and internationally as one of the most progressive and respected clinical research sites in the United States. Over the past 16 years, CURC has participated in over 300 national and international clinical research trials for patients with various urologic conditions. Areas of clinical research include prostate cancer, bladder cancer, renal cell carcinoma, benign prostatic hyperplasia (BPH), erectile dysfunction, overactive bladder, urinary incontinence, urinary tract infections, kidney stones, as well as biomarker studies.
Dr. Neal Shore, MD, FACS, Director, CPI, Carolina Urologic Research Center stated “CURC looks forward to enrolling subjects in the Theralase clinical trial for NMIBC patients. We look forward to successful trial accrual, as Photo Dynamic Therapy (“PDT”) may potentially provide innovative cancer efficacy for NMIBC patients”.
With the addition of CURC, the Company now has 5 clinical study sites open in Canada and 4 in the US for patient enrollment and treatment for Study II.
Shawn Shirazi PhD, Chief Executive Officer, Theralase®, stated, “With the addition of CURC, we are one step closer to reaching our goal of treating 11 additional patients in early 2021. It is our expectation that the rate at which patients are recruited and treated will increase as we continue to add more clinical sites.”