Theralase Technologies Inc (CVE:TLT) expects investigational testing authorization for its TLC-3200 laser system and TLC-3400 DFOC technology to be granted in November of this year.
The cold laser specialist said it was working its way through the application process with Health Canada and there was a possibility that the government health department could come back with further questions about the application, which would delay the granting of the investigational testing authorization (ITA) by a further 10 days or 45 days (or so), depending on whether the agency requests further information from Theralase.
Theralase wants to use the technology in conjunction with its clinical trial application-approved photo-dynamic compound, TLD-1433, in 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 nanometers, 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 said it filed its ITA application with Health Canada on 29 July of this year, and then provided a comprehensive response to Health Canada’s initial questions that was received by Health Canada on 26 September.
Health Canada has indicated it will take around 45 days to review Theralase’s response document.
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.
“It has taken significant time and resources to complete the required testing by Health Canada and to adequately address their questions, in order to be in a position to receive final ITA approval of the TLC-3200 PDT Laser System and TLC-3400 DFOC technology,” revealed Roger Dumoulin-White, president and chief executive officer of Theralase.
“Theralase is confident that the detailed written response that it has supplied Health Canada will result in a final ITA approval in mid-to-late November 2016, allowing commencement of a Phase Ib clinical trial for NMIBC. We look forward to a favourable and timely review by Health Canada to allow the Company the ability to commence the Phase Ib clinical study for NMIBC,” he added.
Story by ProactiveInvestors