Theralase® Demonstrates 24 Months Stability of Second Clinical Batch of Lead Anti-Cancer Drug
Toronto, Ontario – November 21, 2017
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: 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 a second clinical batch of its lead anti-cancer PDC, TLD-1433.
The confirmation of 24 months long term stability of the second clinical batch of TLD-1433 ensures that sufficient amount 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 second clinical batch of TLD-1433, in the most recent testing report, demonstrated that its purity has changed less than 0.8% 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.
The Company has now achieved 6 months accelerated stability and 24 months long term stability testing for the second clinical batch of its lead drug, TLD-1433.
The next long term stability reporting period will be at 36 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 24 months, respectively, allowing use in treating patients in a clinical study.
Theralase is focused on enrolling and treating the last 5 patients in a Phase Ib clinical trial for patients afflicted with 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).
The first part of the Phase Ib NMIBC clinical study has successfully been completed achieving primary and secondary endpoints for the first three patients treated at the Maximum Recommended Starting Dose (“MRSD”) (0.35 mg/cm2) evaluated at both 90 and 180 days post treatment.
The second part of the Phase Ib NMIBC clinical study, once the final five patients have been enrolled and treated, will be evaluated primarily at 90 days and secondarily at 180 days post treatment for the primary and secondary endpoints at the Therapeutic Dose (0.70 mg/cm2).
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF) 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 have demonstrated an ability to localize to cancer cells and then when laser light activated, effectively destroy them.
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