Toronto, Ontario – May 19, 2020, Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (“PDC”) and their associated drug formulations to safely and effectively destroy various cancers is pleased to announce today that the Company has received Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) authorization to conduct a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”) in the United States.
Study II, entitled, “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Bacillus Calmette-Guerin (“BCG”)-Unresponsive Non-Muscle Invasive Bladder Cancer (“NMIBC”) Patients or Patients who are Intolerant to BCG Therapy” was successfully launched in Canada at 4 clinical study sites (with 1 additional clinical study site in advanced negotiation) and now with FDA IND authorization, the Company plans to launch approximately 15 clinical study sites in the United States for a total of approximately 20 clinical study sites.
Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of the Study Drug (TLD-1433, Theralase’s patented PDC), in conjunction with the Study Device (TLC-3200 Medical Laser System) intended to deliver a safe and effective treatment (“Study Treatment”) to patients inflicted with Carcinoma In-Situ (“CIS”), BCG-Unresponsive NMIBC.
Study II is focused on enrolling and successfully treating approximately 100 CIS, BCG-Unresponsive NMIBC patients in approximately 20 clinical study sites located in Canada and the US.
Study II has a:
- Primary endpoint of efficacy (measured by Complete Response (“CR”)) at any point in time
- Secondary endpoint of duration of CR at approximately 360 days post-initial CR
- Tertiary endpoint of safety (measured by incidence and severity of adverse events grade 4 or higher that do not resolve within approximately 360 days post-initial treatment)
In July 2019, Theralase signed an agreement with a urology Trial Management Organization (“TMO”) to provide approximately 6 US-based study sites. In addition, the Theralase clinical study coordination team has identified and commenced the onboarding process for 9 other US based clinical study sites; including: negotiating clinical research agreements, clinical study budgets and preparing documentation for their Research Ethics Board (“REB”) approval. Now that FDA IND authorization has been received, the Theralase clinical study coordination team can complete the onboarding process required to successfully launch these clinical study sites in the US.
Shawn Shirazi, Ph.D., Chief Executive Officer (“CEO”) Theralase, stated, “I am pleased that FDA IND authorization to commence Study II in the US has been received. Achievement of this strategic objective will allow Theralase to quadruple the number of clinical Study II sites, allowing us to expedite our strategic objectives of both enrolling and successfully treating approximately 100 CIS, BCG-unresponsive NMIBC patients, subject, of course, to both the Canadian and US economies successfully emerging from the current COVID-19 pandemic.”
Shawn Shirazi went on to say, “In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval (“FTA”) post receipt of the FDA IND authorization, based on the clinical study data collected to date. It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation (“BTD”) and / or Accelerated Approval (“AA”), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated.”
Study II Update:
Theralase has successfully launched 4 Canadian study sites (with 1 additional clinical study site in advanced negotiation) and has successfully treated a total of 12 patients (8 patients at University Health Network (“UHN”), Toronto, Canada and 4 patients at McGill University Health Centre (“MUHC”) in Montreal, Canada).
Due to the current COVID-19 pandemic, the Canadian clinical study sites are currently on hold for patient enrolment and treatment. No new patients have been enrolled or treated at any Canadian clinical study site, since early March 2020, and no existing patient currently enrolled in the clinical study will be treated a second time or evaluated clinically, until the federal government, respective provincial governments and executive committees of the respective hospitals deem the clinical study sites able to re-commence Study II. Theralase is in constant communication with all clinical sites for any update on re-starting the enrollment and treatment activities of Study II.
Additional Clinical Targets:
When Study II is well underway with the majority of the approximately 20 study sites open and recruiting patients, the Company expects to expand the breadth of oncological indications as Theralase has now developed significant expertise and intellectual property of its patented PDCs, in the area of photopharmacology and anti-cancer therapy, with data acquired from preclinical models of human disease. Extensive preclinical research has been conducted with Rutherrin®, a patented formulation of the Company’s lead PDC (TLD-1433) combined with transferrin. The Company has demonstrated significant anti-cancer efficacy of Rutherrin®, across numerous preclinical models; including: GlioBlastoma Multiforme (“GBM”) and Non-Small Cell Lung Cancer (“NSCLC”).
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:
Kristina Hachey, Chief Financial Officer