Theralase Files Investigational New Drug Application with the FDA
Toronto, Ontario – October 01, 2019, 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 filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) to initiate a Phase II, Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”) of Theralase’s anti-cancer Photo Dynamic Therapy (“PDT”) technology in patients using the Companies patented PDC, TLD-1433 combined with it’s proprietary TLC-3200 medical laser system.
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 at the University Health Network (“UHN”) with Theralase actively pursuing up to 4 additional clinical study sites in Canada. Pending FDA approval, the Company plans to launch up to 16 clinical study sites in the US. Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433, in the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”) in approximately 20 clinical study sites located in Canada and the US. The study will have a primary endpoint of efficacy (measured by Complete Response (“CR”)) at any point in time, a secondary endpoint of duration of CR at approximately 360 days post-initial treatment and a tertiary endpoint of safety measured by incidence and severity of adverse events grade 4 or higher that do not resolve within 360 days post-initial treatment .
In June 2019, a conference call with the FDA confirmed that the Company’s clinical protocol of Study II met FDA Guidance for Industry dated February 2018 on “BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment”. The guideline stated that “In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application.”1
Shawn Shirazi, Ph.D., CEO – Drug Division, Theralase stated “Based on the high safety and the efficacy results demonstrated in the Phase Ib study, the TLD-1433 Anti-Cancer Technology (“ACT”) platform has the potential to be a viable treatment solution for NMIBC, if the Company is able to duplicate the efficacy results observed in the Phase Ib clinical study (67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and treated, Theralase plans to meet with the FDA to review the results, with a focus on obtaining accelerated approval of the Companies ACT-PDT.
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.
1“BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment – Guidance for Industry” Dated: February 2018
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