One step closer!!
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 drug formulations, 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” 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 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:
Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC
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 will 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
Arkady Mandel, MD, PhD, DSc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase said that “Theralase is proud of the hard work delivered by our clinical, technical, scientific, regulatory and administrative teams that have resulted in Health Canada’s decision to grant the Company CTA and ITA approval to commence a Phase II NMIBC clinical study, subject to REB approval. 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”.
