Theralase Technologies Inc (CVE:TLT) has filed an investigational testing authorisation (ITA) request with Health Canada relating to a Ib clinical trial for a cancer treatment.
Specifically, the company wants to use its patent-pending TLC-3200 photo dynamic therapy (PDT) laser system and TLC-34XX dosimetry fibre optic cage (DFOC) technology, in conjunction with its clinical trial application (CTA) approved lead photo dynamic compound (PDC), TLD-1433, in a phase Ib clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC).
In depth: Theralase's laser technology: "It's light, Jim, but not as we know it"
That’s a lot of acronyms to deal with, so let’s have a look at what the Theralase technologies do.
The TLC-3200 PDT laser system delivers green laser light, at a wavelength of 525 nanometres, while the DFOC technology precisely monitors the laser light to provide a uniform distribution of the laser light energy, in the correct dosage, to the bladder wall.
The company has opted to target treatment of NMIBC initially, because the disease recurrence rate is depressingly high 80%, and there have been no breakthrough developments in the last 20 years, despite it being the fifth most common type of cancer.
Pending Health Canada approval of the ITA, Theralase will immediately commence enrolment of patients into a Phase Ib clinical study in the treatment of NMIBC. The primary outcome measures of the Phase Ib clinical study will be safety and tolerability, with a secondary outcome measure of pharmacokinetics (where the drug accumulates in tissue and how it exits the body) and an exploratory outcome measure of efficacy.
"The company and its team of dedicated professionals have worked tirelessly over the last seven months to design, optimise, test and manufacture the hardware and software of the TLC-3200 PDT Laser System and the TLC-34XX DFOC technology and to compile the data for a Health Canada ITA application, providing support for claims of: biocompatibility, sterility, electrical safety, functionality and mechanical integrity of the technology," said Roger Dumoulin-White, president and chief executive officer of Theralase.
“We look forward to a favourable and timely review by Health Canada to allow us the ability to commence the Phase Ib clinical study for NMIBC,” he added.