Theralase(R) Optimizes Phase II Bladder Cancer Clinical Study - Seite 2

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase stated, "Theralase is delighted in Health Canada's decision to grant the Company a CTA-A for Study II. These recent optimizations to Study II's clinical protocol allow Study II to be in better compliance for Canadian and US regulators, who will ultimately be responsible for reviewing and making the final decision on approving or denying the investigational treatment for human use. By working with Health Canada and the FDA to approve the optimization of the clinical study design, analysis and reporting structure of Study II early in the process, Theralase is able to much better align the clinical data collected in Study II with best practices and current expectations of the Canadian and US regulators; thereby, helping to avoid difficult to address questions at final review time. Theralase hopes that by introducing these optimizations in Study II, future reviews with the regulators will be more efficient. In addition, Theralase is collecting the survival data for all patients, with central pathology laboratory validation, who have been previously enrolled and provided the primary Study II Treatment and who have demonstrated a CR or IR at any point in time, with duration of that CR or IR at 450 days, for submission to the FDA in support of a pre-Break Through Designation ("BTD") submission."

About Theralase Technologies Inc.:

Theralase is a clinical stage pharmaceutical company dedicated to the research and development of light and radiation activated compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

Additional information is available at www.theralase.com and www.sedarplus.ca

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