TORONTO, ON / ACCESSWIRE / July 24, 2019 / Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers, is pleased to announce that the Company has signed an agreement with a Trial Management Organization (“TMO”) to provide 4 to 6 US based urology study sites that will be able to commence enrolling and treating patients, subject to Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) approval for its Phase II Non Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study (“Study II”).
The TMO is in discussions with approximately 14 potential US based clinical study sites that are large integrated clinical urology practices. The TMO’s mandate is to expeditiously complete clinical studies in uro-oncology. Each of these individual clinical study sites has a dedicated and robust clinical infrastructure that is lead by experienced principal investigators and clinical research co-ordinators. The TMO has a highly structured approach to executing and managing clinical studies, which allows a rapid enrolment and treatment of patients according to clinical protocols.
Shawn Shirazi, Ph.D., CEO – Drug Division, Theralase stated that, “This is an important step in our onboarding of US Based clinical study sites. In conjunction with this TMO and its network of clinical study sites, Theralase will select 4 to 6 clinical study sites that could potentially enroll and treat between 25 to 50 of the approximately 100 patients the Company is expecting to recruit and treat in its Phase II Clinical Study, subject to US FDA IND approval. This agreement greatly assists our US study site onboarding and patient enrollment as the Company prepares to file the IND application and negotiate onboarding additional study sites with other organizations in the US”.
Dr. Shirazi further stated that, “Through the lengthy process of identification and selection of clinical study sites, I am pleased to mention that our clinical study co-ordinators and myself are diligently working on finalizing 4 additional sites in Canada, 5 in the US (in addition to the TMO study sites) and 5 in Europe. Although enrolling and treating patients at the US and European sites is subject to the approval of the FDA and the European Medicines Agency, the Company is able to negotiate clinical research agreements, budgetary requirements and other non-regulatory related activities for each US and European study site prior to obtaining regulatory approval, thus potentially expediting patient enrollment and treatment in Study II. Overall, very exciting times ahead for the Company as it continues moving forward with providing a viable treatment option to patients inflicted from Bacillus Calmette Guerin (“BCG”) unresponsive NMIBC.”
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.
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.
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