Profile image
By ProactiveInvestors (Reporter)
Contributor profile | More stories
Story Views

Last Hour:
Last 24 Hours:

Theralase receives Health Canada nod for TLC trial

Thursday, October 20, 2016 7:41
% of readers think this story is Fact. Add your two cents.

Theralase Technologies Inc. (CVE:TLT) said on Thursday that Health Canada has granted investigational testing authorisation (ITA) approval to use its patent-pending TLC-3200 photodynamic therapy (PDT) laser system and TLC-3400 dosimetry fibre optic cage (DFOC) technology.

The green light comes in conjunction with Theralase’s 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 (the branch of pharmacology concerned with the movement of drugs within the body) of TLD-1433.

“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,” said Roger Dumoulin-White, president and chief executive officer of Theralase.

“We look forward to commencing a phase Ib clinical study for NMIBC and demonstrating to the world what this technology is truly capable of.”

Story by ProactiveInvestors


We encourage you to Share our Reports, Analyses, Breaking News and Videos. Simply Click your Favorite Social Media Button and Share.

Report abuse


Your Comments
Question   Razz  Sad   Evil  Exclaim  Smile  Redface  Biggrin  Surprised  Eek   Confused   Cool  LOL   Mad   Twisted  Rolleyes   Wink  Idea  Arrow  Neutral  Cry   Mr. Green

Top Stories
Recent Stories



Top Global

Top Alternative



Email this story
Email this story

If you really want to ban this commenter, please write down the reason:

If you really want to disable all recommended stories, click on OK button. After that, you will be redirect to your options page.