TORONTO, ON / ACCESSWIRE / July 29, 2019 / Theralase® Technologies Inc. (“Theralase” or the “Company”) (TLT: TSXV) (TLTFF: OTCQB), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds (“PDC”) and their associated drug formulations, intended to safely and effectively destroy various cancers, announced today that the first patient has been enrolled into its Phase II clinical study titled “Patients with Non-Muscle Invasive Bladder Cancer (“NMIBC”), who present with Carcinoma In-Situ (“CIS”), who are considered Bacillus Calmette Guérin (“BCG”) Unresponsive or are intolerant to BCG Therapy (“Phase II”)” at University Health Network (“UHN”) in Toronto.
Phase II has been designed in compliance with FDA industry guidelines for BCG-unresponsive NMIBC (issued:February 2018) and defined by the FDA in a Pre-Investigational New Drug (“IND”) conference call in late June 2019. The study will utilize the Therapeutic Dose (0.70 mg/cm2) of the Company’s lead PDC TLD-1433 and will focus on the treatment of approximately 100 BCG-unresponsive NMIBC patients who present with CIS in approximately 20 clinical sites located in Canada and the US, with a primary endpoint of efficacy and a secondary endpoint of safety. The Company is no longer pursuing European study sites due to the exorbitant costs of regulatory approval.
The primary endpoint of the Study will be:
Efficacy - Evaluated by Complete Response (“CR”) at any time in patients with CIS with or without papillary disease post-initial treatment duration response.
The secondary endpoint of the Study will be:
Duration of CR evaluated at 360 days post-initial treatment.
The tertiary endpoint of the Study will be:
Safety - Evaluated by the incidence and severity of Adverse Events (“AEs”) Grade 4 or higher that do not resolve within 360 days post-treatment; whereby:
Grade 1 = Mild
Grade 2 = Moderate
Grade 3 = Severe
Grade 4 = Life-threatening or disabling
Grade 5 = Death
Shawn Shirazi, Ph.D., CEO - Drug Division, Theralase stated that, “The enrollment of the first patient at UHN represents a major milestone for Theralase. I am pleased that the Phase II ACT-NMIBC clinical study has enrolled and will be treating its first patient. Our primary focus has been to onboard sites in Canada followed by the US and Europe; however, as we have been successful in signing an agreement with a Trial Management Organization (“TMO”) in the US, we no longer will be proceeding with European study site onboarding at this time. The addition of the TMO has increased the anticipated number of US clinical sites, thereby negating the need to open up European sites and ultimately a significant cost savings for the Company.”
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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