Thursday, October 20, 2016 7:09:38 AM
The TLC-3200 PDT Laser System delivers green laser light, at a wavelength of 525 nanometers ("nm"), 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 be comprised of subjects with high risk, Ta/T1 or TIS NMIBC that are intolerant or refractory to Bacillus Calmette-Guérin ("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 CEO 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."
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