Canadian Clinical Study Sites Re-Commence Bladder Cancer Study
Toronto, Ontario – 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, announced today 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”).
|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
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers.
Forward Looking Statement:
This news release contains “forward-looking statements” which reflect the current expectations of Company’s management for future growth, results of operations, performance, business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Wherever possible, words such as “may“, “would“, “could“, “should“, “will“, “anticipate“, “believe“, “plan“, “expect“, “intend“, “estimate“, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions; including, with respect to the ability of the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its commercialization plans. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
Chief Financial Officer
416-699-LASE (5273) x 224
1 “BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment – Guidance for Industry” Dated: February 2018