Health Canada Approves Commencement of Phase II Clinical Study
Toronto, Ontario – September 10, 2018
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations, intended to safely and effectively destroy various cancers, announced today that Health Canada has approved the Company’s Clinical Trial Application (“CTA”), allowing clinical study evaluation of Theralase’s lead anti-cancer drug, TLD-1433.
The CTA approval allows Theralase to authorize clinical oncology sites in Canada to enroll and treat patients in a pivotal Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”), pending Health Canada Investigational Testing Authorization (“ITA”) for the Theralase TLC-3200 Medical Laser System and Research Ethics Board (“REB”) approval, both expected in due course.
Study II titled, “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer or Patients Who are Intolerant to BCG Therapy” will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the treatment of approximately 100 NMIBC patients in approximately 20 clinical sites located in Canada, the US and internationally, with a primary endpoint of efficacy.
Oncology sites will be launched in Canada, pending Health Canada Approval, in the US, pending Food and Drug Administration approval, and internationally, pending international regulatory approval.
The primary endpoint of the Study II design will be:
Efficacy – Evaluated by Complete Response (“CR”) in patients with Carcinoma In-Situ (“CIS”) with or without resected papillary disease at 90 days post-treatment with duration of CR evaluated at 360 days post-treatment.
Patient CR is defined as at least one of the following:
1) Negative cystoscopy and negative (including atypical) urine cytology
2) Positive cystoscopy with biopsy-proven benign or low-grade NMIBC
3) Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative
The secondary outcome endpoint of the Study design is proposed to 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
Proposed Clinical Treatment Plan:
Arkady Mandel, MD, PhD, DSc., Interim Chief Executive Officer and Chief Scientific Officer, stated that, “We are all extremely proud of this accomplishment and look forward to proving the efficacy of our advanced anti-cancer technology platform in a patient population inflicted with this deadly disease. Health Canada CTA approval marks another important milestone achievement for Theralase allowing us to expedite clinical development and, if successful, commercialization of TLD-1433 anti-cancer therapy in NMIBC. Following the successful launch of the Phase II study in Canada, the Company plans to commence clinical development internationally. A growing body of pre-clinical and clinical research strongly suggests TLD-1433 may play a critical role in the effective treatment of NMIBC, both CIS and high-grade papillary bladder cancer (Ta and T1). Pending ITA and REB approval, in conjunction with securing the requisite funding, Theralase plans to authorize select Canadian oncology locations and their respective Principal Investigators to commence enrolling and treating NMIBC patients using our approved clinical PDT treatment procedure.”
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations to safely and effectively destroy various cancers. The Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions.
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 development and commercialization of the TLC-2000, including with respect to ongoing redesign work and regulatory clearance process for expanded claims and the Company’s development and commercialization strategy with respect to its Anti-Cancer Technology. 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 successfully complete the redesign work under the proposed timeframe and scope of work or at all, the availability of financing to advance the development of the TLC-2000, the ability of the Company to secure further regulatory clearances (including with respect to expanded claims) from Health Canada and/ or the FDA with respect to the TLC-2000 under the proposed timeframe and scope or at all, the ability of the Company to achieve wider commercial distribution of the TLC-2000, the ability of the Company to execute its strategy with respect to its Anti-Cancer Technology, the ability of the Company to secure further regulatory approvals from Health Canada and/ or the FDA for its NMBIC clinical studies and the ability of the Company to finalize development of, and successfully commercialize, its Anti-Cancer Technology. 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 news 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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