Theralase Technologies Inc (CVE:TLT) has taken another step towards a clinical trial of its cold laser/photo-dynamic cancer treatment with the successful completion of a 12-month stability trial.
Long term stability is essential in the components of a new drug and they are tested over three years, with twelve months one of the key staging posts.
The TLD-1433 compound also completed six months of accelerated stability and by clearing these two stability hurdles the treatment can now be used use in treating human patients in a clinical study.
Theralase is aiming for a Phase Ib clinical trial for patients afflicted with Non-Muscle Invasive Bladder Cancer utilising the light-activated treatment.
The clinical study will commence by instilling a low dose of TLD-1433 drug into the bladders of three patients with subsequent light activation using the TLC-3200/TLC-3400 medical laser technology.
The patients will be monitored for thirty days to ensure safety and tolerability of the procedure.
If no adverse events are reported, an additional six patients will be enrolled at a high dose, followed by light activation and follow-up monitoring for six months.
For the nine months to September, Theralase registered a loss C$3.92mln, though revenues picked up 14% to C$1.21mln.