Theralase Technologies announced it demonstrated a 24 months long-term stability of a second clinical batch of its lead anti-cancer photo dynamic compounds TLD-1433.
Theralase Technologies (TSXV:TLT; OTCQX:TLTFF) announced it demonstrated a 24 months long-term stability of a second clinical batch of its lead anti-cancer photo dynamic compounds (PDC) TLD-1433.
As quoted in the press release:
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.