Regulatory Updates from Health Canada and US FDA
TORONTO, ON / ACCESSWIRE / June 27, 2019 /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 their associated drug formulations intended to safely and effectively destroy various cancers, announced today that the Company has completed a successful Pre-Investigational New Drug (“IND”) meeting with the US Food and Drug Administration (“FDA”). In addition, Health Canada approved the amended Investigational Testing Application (“ITA“) for its Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC“) clinical study (“Phase II Study“).
Pre-IND Meeting
The Company completed a Pre-IND meeting with the FDA and it was confirmed that the Company’s design of the Phase II ACT-NMIBC clinical study met FDA Guidance for Industry dated February 2018 on “BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment”. The guideline states 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 that “We can now proceed with completing and filing an IND application with request for fast track designation, which pending approval, would allow the Company to expeditiously and effectively extend our clinical study into the US, to qualify and onboard clinical sites. In addition, the Company is continuing to qualify Canadian sites and working towards the European Medicines Agency approval, to qualify and onboard European clinical sites for a total of approximately 20 clinical sites.
Amended ITA
The amended ITA was submitted to Health Canada to update the current ITA, for an optimized design of the TLC-3200 medical laser system (“Study Device“).
The Study Device optimizations, include:
- A more powerful laser engine (reduces patient treatment times)
- Higher precision and repeatability in laser light detection (higher patient efficacy)
- Increased robustness in laser power capacity and operator handling (higher patient safety)
- Reduced physical size allowing for use of a flexible cystoscope (higher patient safety)
- An ability to detect laser emitter movement during the Study Procedure (higher patient safety)
- An optimized graphical user interface and system feedback control to allow the principal investigator to operate an “on-off” operation to deliver an effective Study II treatment
Kipton Lade, B.Sc, M.Sc. MBA, CEO – Device Division, Theralase stated that, “Approval of the amended ITA and CTA allows our clinical study sites to update their Research Ethics Board (“REB“) approvals to utilize the optimized Study Device. The optimized Study Device allows for shorter treatment times, increased efficacy and increased patient safety. We hope that these optimizations translate into a successful completion of the Phase II clinical study for the Company and potentially in the future allowing patient’s to be treated in a non-operating room environment.”
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
Additional information is available at www.theralase.com and www.sedar.com
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:
1.866.THE.LASE (843-5273) x304
416.699.LASE (5273) x304
Amelia Tudo, Investor Relations Coordinator
atudo@theralase.com
www.theralase.com
SOURCE: Theralase Technologies Inc.
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