1st U.S. Clinical Testing Site Announcement TORONTO, ON / ACCESSWIRE /January 19, 2021 / Theralase® Technologies Inc. ("Theralase" or "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 Virginia Urology ("VU") 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 are intolerant to BCG Therapy ("Study II").
Theralase has central IRB approval to launch a number of US clinical sites, subject to local site IRB approval. VU is the first site to receive both central and local site IRB approval. There are 5 additional US clinical study sites that have received central IRB approval and are expected to receive local IRB approval in 1Q2021.
VU has a long history of providing quality care to the Greater Richmond area since 1929. VU is comprised of 6 locations throughout the Greater Richmond area with over 55 board-certified physicians that span nearly every discipline within the field of urology. Because VU consists of diverse medical professionals, they are able to provide the latest technologies with a mission of providing the best possible care for each patient.
Dr. Eugene Kramolowsky II, M.D., a Urologic Oncologist at VU Research Department stated "We are excited to work with Theralase for the NMIBC clinical study. Tackling cancer is a crucial topic and a priority for this region, and I am pleased that Virginia Urology is able to contribute to the growth of innovative cancer research by taking part in this leading pivotal Photo Dynamic Therapy ("PDT") study".
To date 14 patients have been treated in Study II. With the addition of VU, the Company now has 5 clinical study sites open in Canada and 1 in the US for patient enrollment and treatment.
Shawn Shirazi PhD, Chief Executive Officer, Theralase®, stated, "We are excited to have central IRB approval, which will help expedite the launch of other US clinical study sites subject to local IRB approval. VU is now able to commence patient enrollment and treatment in the US. We look forward to increasing the number of patients enrolled and treated in Study II, as a result of launching additional clinical study sites in the US."
About Study II
Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the US.
Study II has a:
Primary endpoint of efficacy (defined by Complete Response ("CR") at any point in time
Secondary endpoint of duration of CR at 360 days post-initial CR (approximately 450 days post initial Study treatment, assuming CR is achieved at the 90 day assessment)
Tertiary endpoint of safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 450 days post-initial treatment
The FDA, in its 2018 guidance to industry has stated that, "For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:
Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
For intravesical therapies without systemic toxicity, the FDA includes, in the definition of a CR, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR."1
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