Theralase Demonstrates 24 Month Stability of Lead Anti-Cancer Drug
ACCESSWIRE ACCESSWIRESeptember 18, 2017
TORONTO, ON / ACCESSWIRE / September 18, 2017 / Theralase Technologies Inc. ("Theralase®" or the "Company") (TSX-V: TLT) (OTCQX: TLTFF), 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 24 months long term stability of its 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 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.
TLD-1433, in the most recent testing report, demonstrated that its purity has changed less than 1.7% in 24 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.
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 months accelerated stability and 24 months long-term stability testing have now been successfully completed.
The next long-term stability reporting period will be at 36 months.
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