Theralase Holds pre-CTA Meeting with Health Canada
April 2, 2015 (Source: Accesswire) — Theralase Technologies Inc. (“Theralase” or the “Company”) (TSX-VENTURE:TLT) (PINKSHEETS:TLTFF) announced today that it recently held a pre “Clinical Trial Application” (“CTA“) consultation meeting with Health Canada (“HC“) with the objective of presenting its Photo Dynamic Therapy (“PDT“) technology in the treatment of cancer and seeking clinical trial design guidance.
According to Health Canada, a clinical trial is defined as, “An investigation in respect of a drug, for use in humans, that involves human subjects, and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug.”
Roger Dumoulin-White, President and CEO presented Theralase’s corporate vision, preclinical data and Phase Ib clinical trial design for the Company’s lead Photo Dynamic Compound (“PDC“), TLD-1433 to a panel of HC regulators. TLD-1433 is being developed for the indication of Non-Muscle-Invasive Bladder Cancer (“NMIBC“) with a primary outcome measure of patient safety and tolerability and a secondary outcome of efficacy.
After the presentation, Theralase representatives entered into discussions with HC on the toxicology analyses and Phase I b clinical study design to clarify and seek guidance to ensure regulatory compliance. Theralase achieved its objective of understanding HC’s expectations and regulations governing clinical study design, which will help in obtaining HC CTA approval to commence the clinical trial in a timely manner.
Dr. Arkady Mandel, Chief Scientific Officer stated that, “I am pleased that Theralase was able to present our pre-clinical data and clinical study design to HC to aid in the overall understanding of the benefits and opportunity that this technology represents. By having our key questions on the toxicology analyses and clinical study design openly discussed, we now have a better understanding on the requirements to successfully execute our Phase Ib clinical study in support of our claims of safety, tolerability and efficacy. Now that the pre-CTA meeting with HC has been held, we can focus on execution of our next strategic initiatives, which include: completion of the manufacture of our lead drug in accordance with Good Manufacturing Practice (“GMP“) standards, completion of our toxicological analyses and finally completion and submission of a CTA to HC. With HC’s approval of the CTA, we will be authorized to commence patient enrollment into our Phase Ib clinical study.”
Roger Dumoulin-White, President and CEO stated, “We were pleased with the open and engaging discussions with HC at the pre-CTA meeting. It was an important opportunity for us to present the Company and its research objectives. As Theralase executes on our key strategic initiatives in 2Q2015 and 3Q2015, we should be in a position to commence our human clinical studies in NMIBC in 4Q2015.”
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About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase(R)“) (TSX-VENTURE:TLT) (PINKSHEETS:TLTFF) in its Therapeutic Laser Technology (“TLT“) Division designs, manufactures and markets patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT“) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs“), which are able to localize to the cancer cells and then when laser light activated, effectively destroy them.
Theralase Technologies Inc. was recognized as a TSX Venture 50(R) company in 2015. TSX Venture 50 is a trademark of TSX Inc. and is used under license.
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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