Friday, September 18, 2015 7:57:01 AM
2015-09-18 07:06 ET - News Release
Mr. Michael Borovec reports
THERALASE SUBMITS INVESTIGATIONAL TESTING AUTHORIZATION TO HEALTH CANADA FOR APPROVAL
Theralase Technologies Inc. has submitted an investigational testing authorization (ITA) for its anti-cancer technology to Health Canada for approval.
The ITA details information about the proprietary Theralase TLC-3200 oncology laser system, which Theralase plans to use to activate the company's lead photodynamic compound (PDC), TLD-1433, to destroy non-muscle invasive bladder cancer (NMIBC).
Pending approval of the following applications, Theralase plans to commence enrolling patients inflicted with NMIBC into a phase Ib clinical study at Princess Margaret Cancer Centre, University Health Network (UHN), to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy:
Health Canada clinical trial application (CTA) (complete);
Health Canada ITA (complete);
UHN Research Ethics Board (REB).
Roger Dumoulin-White, president and chief executive officer, Theralase, stated: "The submission of an ITA to Health Canada for NMIBC is yet another advancement for the company in its quest to prove the safety, tolerability and efficacy of its anti-cancer technology in the destruction of NMIBC. Pending approval of the CTA, ITA and REB, UHN will commence enrolling and treating patients inflicted with this deadly disease."
We seek Safe Harbor.
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