TLTFF: TLT Demonstrates 12 Month Stability of Lead Anti-Cancer Drug
Toronto, Ontario - November 30, 2016, Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that it has demonstrated 12 month long term stability of it lead anti-cancer Photo Dynamic Compound ("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 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 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 changes occur 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.
6 month accelerated stability and 12 month long term stability testing have now been successfully completed.
TLD-1433 has now demonstrated that it has remained stable at these reported time periods and according to Health Canada guidelines, long term and accelerated stability has now been proven at 6 months accelerated and 12 month long term, allowing use in treating patients in a clinical study.
Theralase 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 and exit of drug within tissue) and an exploratory endpoint of efficacy.
