Health Canada Grants ITA Approval to Commence Phase II Clinical Study
Toronto, Ontario – December 10, 2018
Theralase Technologies Inc. (“Theralase®” or the “Company”)(TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drugformulations, intended to safely and effectively destroy various cancers, announced today that Health Canada has granted the Company Investigational Testing Authorization (“ITA”) approval to utilize its patent pending TLC-3000 Photo Dynamic Therapy (“PDT”) Laser System, in conjunction with its Clinical Trial Application (“CTA”) approved lead PDC, TLD-1433, to commence enrolling and treating patients in a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”), subject to submitting a Clinical Trial Site Information Form and receipt of their respective Research Ethics Board (“REB”) approval for each Canadian oncology location that will conduct Study II.
The TLC-3000 PDT Laser System delivers green laser light (525 nm), while simultaneously monitoring the laser light to achieve the target dosage at the bladder wall surface, safely and effectively destroying the NMIBC.
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” willutilize 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 first in Canada, followed by the US, pending Food and Drug Administration approval, and then 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 orprostatic urethra and random bladder biopsies are negative
The secondary outcome endpoint of the Study design will be:
Safety – Evaluated by the incidence and severity of Adverse Events (“AEs”) Grade 4 or higher that donot 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
The clinical data collected from the Phase Ib NMIBC clinical study supports our belief that Theralase’s PDT technology offers a new and advanced treatment option for NMIBC BCG-Unresponsive patients, who have exhausted all other available treatment options. TLD-1433 PDT represents a unique approach, using a targeted and patient specific drug and light delivery system.
Theralase® is currently in discussions with a number of world-class uro-oncology centers interested in enrolling and treating patients in a Phase II NMIBC clinical study, subject to final regulatory and REB approvals for the countries in question. Theralase looks forward to demonstrating to the world what this technology is truly capable of.
Theralase® believes that its anti-cancer PDT technology will provide patients, who present with various cancers, and who have failed to respond to standard of care treatment, with new hope and a strong alternative therapy”.
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 Corporation’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding Theralase’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 Theralase to: successfully fund and complete a Phase II NMIBC clinical study, successfully fund and complete a Phase Ib GBM clinical study, successfully fund and complete a Phase Ib NSCLC clinical study, secure the requisite regulatory approvals to commence and fund a Phase II NMIBC clinical study, Phase Ib GBM clinical study and/or a Phase Ib NSCLC clinical study and implement its development plans. Many factors could cause the Corporation’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 Corporation 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 Corporation cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Corporation 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.
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