Toronto, Ontario – March 20, 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, has been notified by all of its Canadian clinical study sites that enrollment of new patients and conducting the first treatment procedure in the Company’s Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”) has been temporarily placed on hold pending resolution of the coronavirus (“COVID-19”) global pandemic.
Due to the global spread of COVID-19 and the uncertainty associated with the virus, the Company is in agreement with the clinical study site’s decision and with provincial and federal government recommendations concerning social distancing, to minimize hospital admittance to only patients with an emergency need.
The clinical study sites have elected to temporarily halt enrollment and first treatment of patients in Study II, pending resolution of COVID-19. The Company is in close contact with the clinical study sites and will continue to work in conjunction with them and the provincial and federal governments to monitor the situation to determine the best time to recommence enrollment and first treatment in Study II.
The clinical study sites will however continue to monitor and treat patients already enrolled in Study II by providing:
1) Continuous monitoring and clinical analysis during scheduled follow-up visits
2) Second treatment procedure
3) Bodily fluid analysis, although this may be completed by a third-party organization
The Canadian clinical study sites on temporary hold, include:
1) University Health Network (“UHN”), Toronto, Ontario
2) London Health Sciences Centre (“LHSC”), London, Ontario
3) McGill University Health Centre (“MUHC”), Montreal, Quebec
4) Nova Scotia Health Authority (“NSHA”), Halifax, Nova Scotia
Study II Update:
UHN and MUHC have enrolled and successfully treated 12 patients to date.
FDA Investigational New Drug (“IND”) Application Update:
Theralase is in the process of responding to the Food and Drug Administration’s (“FDA”) questions regarding the Company’s IND application. Subject to FDA’s IND approval, Theralase plans to launch approximately 14 to 16 clinical study sites in the US.
Shawn Shirazi, Ph.D., CEO of Theralase stated, “Theralase is pleased that we have enrolled and successfully treated 12 patients in Study II and look forward to analyzing and reporting out on the clinical data, when clinically relevant. The Company’s immediate goal is to successfully enroll and treat 20 to 25 patients, who have received two treatment procedures, to provide clinical evidence to Health Canada and the FDA on the primary, secondary and tertiary clinical outcome objectives; which may
then be used to support Breakthrough Therapy Designation (“BTD”) approval from the FDA. The Company is strategically targeting clinical sites across Canada and the US (subject to IND approval) that serve large urban populations to maximize enrollment in Study II.”
About Study II
The Phase II NMIBC Clinical Study 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:
1) Primary endpoint of efficacy (defined by Complete Response (“CR”)) at any point in time
2) Secondary endpoint of duration of CR at 360 days post-initial CR
3) Tertiary endpoint of safety measured by incidence and severity of Adverse Events (“AEs”) grade 4 or higher that do not resolve within 360 days post-initial CR
For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:
1) Negative cystoscopy and negative (including atypical) urine cytology
2) Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
3) 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.
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 management of the Company’s future growth, results of operations, performance and 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 current 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 development 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:
Shushu Feng, Investor Relations & Public Relations Coordinator
Amelia Tudo, Investor Relations & Public Relations Coordinator