TORONTO, ON / ACCESSWIRE / March 18, 2016 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX-V: TLT) (OTC: TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today an update on the 2016 strategic initiatives of the Company.
The Company has two primary divisions, the Therapeutic Laser Technology ("TLT") division and the Anti-Cancer Photo Dynamic Therapy ("PDT") division.
The TLT division is focused on increasing revenues of its next generation TLC-2000 therapeutic laser system in Canada and the US in 2016. Health Canada and the US Food and Drug Administration approved the TLC-2000 for commercial distribution in December 2015. The Company will report revenue generated from the TLT division in fiscal year 2015 on April 29, 2016 and revenue generated in the 1st quarter 2016 on May 30, 2016. Subsequent quarters are expected to show a steady increase in revenue for the TLT division, as acceptance of the TLC-2000 technology builds in Canada and the US. Feedback from the medical community thus far on the TLC-2000 has been exemplary with many healthcare practitioners reporting excellent clinical results in the healing of numerous nerve, muscle and joint conditions on an ever expanding population of patients.
The PDT division is focused on commencing and successfully completing a Phase Ib clinical trial for patients afflicted with Non-Muscle Invasive Bladder Cancer ("NMIBC") utilizing its novel next generation light-activated, anti-cancer drug, TLD-1433.
The Phase Ib NMIBC clinical trial will evaluate TLD-1433 for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement of drug within tissue) and an exploratory endpoint of efficacy in a patient population defined by University Health Network's ("UHN") uro-oncology department to enable drug approval.
To date, the Company has achieved the following approvals:
- Health Canada Clinical Trial Application ("CTA") approval of TLD-1433 (completed)
- UHN Research Ethics Board ("REB") approval of the clinical protocol (completed)
- Health Canada Investigational Testing Application ("ITA") approval of the TLC-3200 medical laser, used to activate TLD-1433 that has absorbed into bladder cancer lesions (pending)
Theralase is currently preparing an updated ITA for submission to Health Canada, in mid- April 2016, for approval on or about the end of April 2016, which addresses the TLC-3200 medical laser and specifically, the fibre optic components which are used to activate the drug inside the bladder.
Health Canada requires information and testing that supports:
- Biocompatibility (the materials that enter the body are proven not harmful to tissue)
- Mechanical testing (the materials demonstrate the characteristics of functional reliability, tensile strength and repeatability of operation)
- Sterility (the materials that enter the body are proven sterile)
ITA approval from Health Canada is thus expected in early 2nd quarter 2016. Enrollment in the Phase Ib NMIBC clinical trial at UHN will commence immediately following ITA approval.
The Phase Ib NMIBC clinical study protocol will begin by instilling a low dose of TLD-1433 drug into the bladders of 3 patients with subsequent light activation using the TLC-3200 medical laser. These 3 subjects will then be monitored for 30 days to ensure safety and tolerability of the procedure. If no adverse events are reported, then an additional 6 subjects will be enrolled at a high dose, followed by light activation and follow-up monitoring for 6 months.
If safety and tolerability of the procedure is demonstrated in these 9 subjects, the Phase Ib study results will support Health Canada approval and a Phase II multi-center efficacy study for NMIBC will be commenced in Canada, the United States and Europe.
Roger Dumoulin-White, President and CEO of Theralase stated, "The Theralase and UHN teams have been working extremely hard to achieve ITA approval to allow commencement of the Phase Ib clinical study to prove the safety and tolerability of the procedure for patients stricken with NMIBC. Although, we have faced some delays in achieving ITA approval, Theralase is committed to commencing the clinical trial in early 2nd quarter 2016, successfully completing it and reporting out on our success in early 2017."
About Theralase Technologies Inc.
Theralase Technologies Inc. ("Theralase®") (TSX-V: TLT) (OTC: TLTFF) in its Therapeutic Laser Technology ("TLT") Division designs, manufactures and markets patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase's Photo Dynamic Therapy ("PDT") Division researches and develops specially designed molecules called Photo Dynamic Compounds, which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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SOURCE: Theralase Technologies Inc.