Demonstrating long term and accelerated 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.
The data collected at three months represent the first reporting period under long term stability and the mid-way point under accelerated stability. TLD-1433 has clearly demonstrated that it has remained stable at these reported time periods. According to Health Canada guidelines, long term and accelerated stability must be demonstrated at 6 months to commence treating patients in a clinical study.
Roger Dumoulin-White, President and CEO, Theralase stated that, “Theralase has shown that TLD-1433, being developed for NMIBC, has passed another hurdle on its way to being evaluated clinically. The Company is confident that TLD-1433 will remain stable over the next 3 months, allowing Theralase the opportunity to get one step closer to proving its primary objective of safety and tolerability, and an exploratory objective of efficacy, in cancer patients afflicted with NMIBC, in a Phase Ib human trial scheduled to commence in late 4Q2015.”