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Health Canada Grants ITA Approval to Commence Phase II Clinical Study
TORONTO, ON / ACCESSWIRE / December 10, 2018 / Theralase Technologies Inc.(" Theralase&#...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Health Canada Grants ITA Approval to Commence Phase II Clinical StudyTORONTO, ON / ACCESSWIRE / 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:1) Negative cystoscopy and negative (including atypical) urine cytology 2) Positive cystoscopy with biopsy-proven b...