Theralase® Provides Corporate Update
Theralase® Provides Update on Upcoming Initiatives for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario – August 27, 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 provided a corporate update on the Phase II for the Non-Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study.
Photo Dynamic Therapy (“PDT”) utilizing the Company’s lead drug, TLD-1433, has met all expectations of the Company in the successfully completed Phase Ib NMIBC Clinical Study.
In the Phase Ib study all 6 patients enrolled and treated (3 at the Maximum Recommended Starting Dose (“MRSD”) (0.35 mg/cm2) and 3 at the Therapeutic Dose (0.70 mg/cm2)) achieved both the primary (safety and tolerability as measured by Adverse Events (“AE”)) and secondary (pharmacokinetics, as measured by PDC remaining in urine and blood) endpoints.
All 3 patients (patients 4, 5 and 6) treated with the Therapeutic Dose achieved a Complete Response (“CR”) at 90 days after PDT. Patients 5 and 6 achieved a CR at 180 days and continue to exhibit a CR. Patient 4 was found to have progressed to metastatic disease after 90 days and was removed from the follow up evaluation. This metastatic progression of disease in patient 4 was unrelated to TLD-1433 PDT.
These results compelled the independent Medical and Scientific Advisory Board (“MSAB”) to recommend to the Company, the early termination of the Study due to achievement of the primary and secondary endpoints. The MSAB also recommended that the clinical data collected from the first three patients treated at the MRSD and the three patients treated at the Therapeutic Dose were sufficient to support the conclusion that the Study had successfully achieved the Study’s primary and secondary endpoints and had adequately addressed the Study’s scientific, technical and clinical questions, as per the approved Study design and clinical protocol. The MSAB recommendation to the Company was to terminate the Study based on the six patients treated to date and suggested that the Company pursue a pivotal Phase II NMIBC clinical study approval with Health Canada and the FDA with efficacy as the primary endpoint.
Patient 5 and 6 in the Phase Ib study, presented with stage T1 High Grade and Carcinoma-In-Situ (“CIS”) NMIBC, respectively, prior to the PDT treatment and regardless of the treatment procedure performed (i.e.: Trans-Urethral Resection of the Bladder Tumour (“TURBT”) and/or Bacillus Calmette Guérin (“BCG”)) had done so for the last 4 and 5 years, respectively).
The 180 day CR of their disease to Theralase’s PDT marks a significant event for both the Company and the patients.
The Phase II NMIBC Clinical Study is currently under Health Canada review and is expected to be submitted to the Food and Drug Administration for review in September 2018.
The Company will work with both Canadian and US regulatory authorities to address any questions they may have about the Phase II clinical study design and expect to receive the requisite approvals to commence the Phase II clinical study in both countries in late 2018 / early 2019.
The Phase II clinical study is anticipated to involve the recruitment, treatment and follow-up of 100 patients providing them two Theralase PDT treatments, one at Day 0 and one at Day 180.
The enrollment, treatment and follow-up of these 100 patients is expected to involve 15 to 25 clinical sites in Canada, the US, and internationally, and is expected to take 3 years to complete.
If the initial data in the Phase II clinical study is favourable compared to standard of care, then early adoption of the technology for commercial application is possible, subject to approval by the requisite
regulatory authority.
Michael Jewett, MD, FRCSC, FACS, Professor of Surgery (Urology) at the University of Toronto and the Chairman of Theralase’s MSAB stated that, “The lack of significant adverse events and early efficacy signal with the six month CR data from the Phase Ib clinical study is encouraging and reinforces our strong support for conducting the Phase II NMIBC clinical study. Theralase’s PDT technology platform may offer a new treatment option for NMIBC patients, who have exhausted all other available treatment options. In contrast to most other areas in cancer therapy, there has not been a significant treatment advance for CIS and/or high-grade NMIBC in decades. TLD-1433 PDT is a unique and innovative approach, using a targeted, patient specific drug and light delivery system. I believe the Theralase PDT treatment will provide NMIBC BCG-Unresponsive patients (patients who have failed the standard of care treatment of TURBT and BCG) with new hope and an alternative for staving off life-altering bladder removal surgery.”
