Theralase Technologies Inc (TLTFF)

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Theralase Demonstrates 36 Months Stability of Lead Anti-Cancer Drug


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 cancer has announced today that it has demonstrated 36 months long term stability of the clinical batch of its lead anti-cancer PDC, TLD-1433.

The confirmation of 36 months long term stability of TLD-1433 ensures that sufficient amounts of the PDC will be available at Good Manufacturing Practice (“GMP”) levels for multiple Photo Dynamic Therapy (“PDT”) patient treatments during the planned Phase 2 clinical study for Non-Muscle Invasive Bladder Cancer (“NMIBC”).

Stability studies are an essential component of pharmaceutical development, allowing evaluation of a drug’s stability under the influence of a variety of environmental factors such as: temperature, humidity and light. Data from these studies enable recommended: storage conditions, retest intervals and shelf life to be established.

Demonstrating long term stability of a drug to be used in human clinical testing is essential to prove that the potency and/or efficacy of the drug is not affected during prolonged shelf life.

The clinical batch of TLD-1433, in the most recent testing report, demonstrated that its purity has been virtually unchanged over 9, 12, 18, 24 and 36 months of long term stability testing, indicating extreme stability of the compound.

Under long term and accelerated stability storage conditions, the drug is evaluated by High Performance Liquid Chromatography (“HPLC”) to separate, identify and quantify each chemical component to a very high degree of resolution to assess if any change occurs in the chemical composition over time.

TLD-1433 has demonstrated that it has remained stable at these reported time periods and according to Health Canada guidelines, accelerated and long-term stability has now been proven at 6 months and 36 months, respectively, allowing use in treating patients in a clinical study.

As previously announced, Theralase has successfully completed a Phase Ib NMIBC clinical trial for TLD-1433 for the primary endpoints of safety and tolerability and secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and looks forward to commencing a multi-center Phase II NMIBC clinical study.

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 cancer. 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.

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