RONTO, ON / ACCESSWIRE / April 22, 2016 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX V: TLT) (TLTFF), a leading biotech company focused on commercialization of medical devices to eliminate pain and development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that it has reached a milestone, demonstrating 6 month accelerated stability and 9 month long term stability of it lead anti-cancer PDC, TLD-1433.
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 lives to be established.
Demonstrating accelerated and 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.
Under accelerated and long term stability storage conditions, the drug is evaluated by High Performance Liquid Chromatography 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.
Long-term stability is completed over three years, with reporting at 0, 3, 6, 9, 12, 18, 24 and 36 months. Accelerated stability is completed over six months, with reporting at 0, 3 and 6 months.
TLD-1433 has now demonstrated stability at 6 months under accelerated conditions and 9 months under long-term stability conditions, satisfying Health Canada guidelines, to allow use in treating patients in a clinical study.
The Company is currently pursuing an Investigational Testing Authorization ("ITA") of its proprietary laser system to activate the PDCs for the indication of Non-Muscle Invasive Bladder Cancer ("NMIBC").
Theralase is focused on commencing and successfully completing a Phase Ib clinical trial for patients afflicted with NMIBC utilizing its novel, next generation light activated, anti-cancer drug, 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.