Cold laser technology specialist Theralase Technologies Inc (CVE:TLT) has started a phase Ib clinical study for the treatment of non-muscle invasive bladder cancer (NMIBC).
The design of the clinical study allows for the initial enrollment of three participants to be treated at a low dose using the light activated photo dynamic compound (PDC), TLD-1433.
The watchwords in medicine are: first do no harm; as such the first three participants in the study will be monitored for thirty days to see whether the treatment is safe and tolerable. If it is, an additional group of six participants will be enrolled at a higher dose and monitored for six months.
Theralase’s laser technology is able to activate light-sensitive PDCs that have an attraction to cancer cells and are able to destroy them when light activated, all without that nasty business involving chemotherapy, radiation or invasive surgery.
The Phase Ib NMIBC clinical trial will evaluate TLD-1433, activated by the TLC-3200 medical laser system in conjunction with the TLC-3400 Dosimetry Fibre Optic Cage, for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement of drug in tissue) and an exploratory endpoint of efficacy.
Should the treatment prove to be safe and tolerable then the next stage would be a Phase II clinical study in Canada, the USA and Europe, for the purposes of determining how effective the treatment is.
"The scientific and pre-clinical data to date has been strongly supportive of commencing a Phase Ib NMIBC clinical study. I look forward to commencing the NMIBC clinical study to investigate whether the successes of this technology pre-clinically can be translated to a clinical population," said Arkady Mandel, chief scientific officer of Theralase.
The company’s president and chief executive officer, Roger Dumoulin-White, said the screening process for the Phase Ib trial enrollment should take about two weeks.