On September 24, 2020 Theralase Technologies Inc. ("Theralase" or "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, reported that McGill University Health Centre ("MUHC") has re-commenced new patient enrollment and treatment in the Company’s Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II") (Press release, Theralase, SEP 24, 2020, View Source [SID1234569759]).

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Study II has enrolled and treated 12 patients to date. Out of the 7 patients that are eligible to receive the second treatment, 5 have been treated and 2 are pending. 2 out of the last 5 patients treated for the second time have been treated with the optimized Study II treatment, which will also be the case for the 2 patients that are pending their second treatment.

Efficacy to date at the 90 day assessment includes:

3 out of 12 patients (25%) have demonstrated a Complete Response ("CR") (Negative cystoscopy and negative (including atypical) urine cytology
3 out of 12 patients (25%) have demonstrated a Partial Response ("PR") (2 patients with negative cystoscopy and positive urine cytology and 1 patient with positive cystoscopy and negative urine cytology), with 2 of these patients having received second treatment.
The Company is in advanced discussions with the US based Trial Management Organization to potentially launch 5 clinical study sites in the United States in 4Q2020, subject to the US economy successfully recovering from the COVID-19 pandemic. If launched in 4Q2020, the Company would expect Study II patient enrollment and treatment in 1Q2021.

Theralase recently submitted an application to the Food and Drug Administration ("FDA") for Fast Track Approval ("FTA"). The application was denied by the FDA, citing certain improvements required to the application. Theralase has revised the FTA application and has resubmitted it to the FDA. Subject to successful FDA approval of the FTA application, Theralase should be in a position to receive FDA FTA approval in 4Q2020.

Shawn Shirazi, Ph.D., Chief Executive Officer of Theralase stated, "Theralase is pleased that all four Canadian clinical study sites are open for new patient enrollment and we are gearing up to launch 5 additional clinical study sites in the US. We are now able to focus on achieving our interim milestone of treating 20 to 25 patients that could support a Breakthrough Designation application to the FDA. The clinical data collected on the first twelve patients treated shows a favorable clinical response after a single PDT treatment, which the Company expects will improve due to the implemented Study II treatment optimization."

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 Bacillus Calmete Guérin ("BCG")-Unresponsive NMIBC patients presenting with Carcinoma In-Situ ("CIS") in up to 20 clinical study sites located in Canada and the US.

Study II has a:

Primary endpoint of efficacy (defined by 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