On August 12, 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 three out of four of its Canadian clinical study sites have 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, AUG 12, 2020, View Source [SID1234568619]).

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Specifically:

Study Site Location Site Status
University Health Network ("UHN") Toronto, Ontario Enrolling
London Health Sciences Centre ("LHSC"), London, Ontario Enrolling
Nova Scotia Health Authority ("NSHA") Halifax, Nova Scotia Enrolling
McGill University Health Centre ("MUHC") Montreal, Quebec COVID-19 Hold
On a go forward basis, all future and existing patients to be enrolled and treated (initial and second treatment) in Study II will be treated using the Study II treatment optimizations as communicated via press release on July 30, 2020, specifically:

Bladder volume calculation
Study drug volume calculation
Study device volume calculation
Study device treatment time
Four of the patients previously treated are awaiting second treatment subject to the clinical study site operating room availability. One additional patient is undergoing additional assessments prior to proceeding to second treatment.

The Company is in advanced discussions to launch a number of US based clinical study sites, subject to the United States economy recovering from the COVID-19 pandemic.

The US based Trial Management Organization ("TMO") could potentially launch 4 clinical study sites in 4Q2020 and commence Study II patient enrollment and treatment in 1Q2021.

Shawn Shirazi, Ph.D., Chief Executive Officer of Theralase stated, "Theralase is pleased that 3 out of 4 Canadian clinical study sites are open for new patient enrollment and treatment receiving the new optimized Study II treatment. The clinical data collected on the first twelve patients treated shows a favorable clinical response, 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 approximately 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)
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
"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