Theralase Demonstrates 18 Month Stability of Lead Anti-Cancer Drug
ACCESS Newswire
TORONTO, ON / ACCESSWIRE / March 15, 2017 / Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT:TSX-V) (TLTFF:OTC PINK), 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 18 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.
TLD-1433, in the most recent testing report, demonstrated that its purity has changed less than 0.34% in 18 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 18 months long term stability testing have now been successfully completed.
The next long term stability reporting period will be at 24 months.
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 18 months, respectively, allowing use in treating patients in a clinical study.
Theralase is currently focused on enrolling patients in 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.
About Theralase Technologies Inc.
Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT.V) (TLTFF:OTC PINK) in its Therapeutic Laser Technology ("TLT") Division designs, manufactures, markets and distributes patented super-pulsed laser technology indicated for the treatment of chronic knee pain, and in off-label use, 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 ("PDCs"), which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
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