Theralase Technologies Inc (TLTFF)

[123414]

Health Canada Approves Commencement of Phase II Clinical Study

Toronto, Ontario (FSCwire) - 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 and their associated drug formulations intended 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.

https://app.quotemedia.com/quotetools/newsStoryPopup.go?storyId=7520419545472635&topic=TLTFF&symbology=null&cp=null&webmasterId=90338