Theralase Submits Phase II Bladder Cancer Clinical Study Application to Health Canada for Review and Approval
Toronto, Ontario – August 20, 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 has submitted a Clinical Trial Application (“CTA”) and Investigational Testing Authorization (“ITA”) for its TLD-1433 anti-cancer technology to Health Canada for review and approval.
Pending Health Canada and the individual Canadian oncology location(s) Research Ethics Board’s (“REB”) approvals, and subject to securing the requisite financing, Theralase plans to commence a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study, entitled, “Photo Dynamic Therapy Using Laser Light Activated TLD-1433 in BCG-Unresponsive Patient Population” (“Study”) with select Canadian oncology locations.
Theralase’s anti-cancer technology utilizes the proprietary Theralase TLC-3200 Medical Laser System to light activate the Company’s lead, patented PDC, TLD-1433, intended to treat NMIBC.
In the proposed Study design, approximately 100 patients will be enrolled and treated at the Therapeutic Dose (0.70 mg / cm2) of TLD-1433. 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 outcome endpoint of the Study design is proposed to 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
Arkady Mandel, MD, PhD, DSc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase stated, “The submission of a CTA and ITA to Health Canada for the Study marks completion of another major milestone for the Company on our way to proving the efficacy of our anti-cancer technology in the destruction of NMIBC. Pending approval of the CTA, ITA and REB, along with securing the required financing, Theralase plans to authorize select Canadian oncology location(s) and their respective Principal Investigator(s) to commence enrolling and treating NMIBC patients using our approved clinical treatment procedure.”
