HEALTH CANADA GRANTS THERALASE ITA APPROVAL
Health Canada has granted Theralase Technologies Inc. (TLT.V) investigational testing authorization (ITA) approval to use its patent-pending TLC-3200 photodynamic therapy (PDT) laser system and TLC-3400 dosimetry fibre optic cage (DFOC) technology, in conjunction with its clinical trial application-approved lead PDC, TLD-1433, to commence a phase Ib clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC).
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.
Theralase, possessing both CTA and ITA approval, plans to immediately commence a phase Ib clinical study for the treatment of NMIBC.
The patient population will comprise subjects with high-risk Ta/T1 or TIS NMIBC that are intolerant or refractory to bacillus calmette-guerin (BCG) and who are not candidates or refuse radical cystectomy.
The primary objective of this study is to evaluate the safety of PDT employing TLD-1433 and controlled laser light distribution via the TLC-3200 and TLC-3400 DFOC system.
The secondary objective of this study is to evaluate the pharmacokinetics (PK) (the branch of pharmacology concerned with the movement of drugs within the body) of TLD-1433.
Roger Dumoulin-White, president and chief executive officer of Theralase, stated that: "Theralase is very proud of the hard work delivered by the team that resulted in Health Canada's decision to grant the company ITA approval of its TLC-3200 and TLC-3400 technologies. I join the entire team in stating that we look forward to commencing a phase Ib clinical study for NMIBC and demonstrating to the world what this technology is truly capable of."