TORONTO, ON / ACCESSWIRE / April 2, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLT.V) (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."