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Theralase Receives FDA IND Authorization
TORONTO, ONTARIO / ACCESSWIRE / May 19, 2020 / Theralase® Technologies Inc. (" Theralas...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Theralase Receives FDA IND AuthorizationTORONTO, ONTARIO / ACCESSWIRE / May 19, 2020 / Theralase® Technologies Inc. (\"Theralase\" or the \"Company\") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (\"PDC\") and their associated drug formulations to safely and effectively destroy various cancers is pleased to announce today that the Company has received Food and Drug Administration (\"FDA\") Investigational New Drug (\"IND\") authorization to conduct a Phase II Non-Muscle Invasive Bladder Cancer (\"NMIBC\") clinical study (\"Study II\") in the United States.Study II, entitled, \"A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Bacillus Calmette-Guerin (\"BCG\")-Unresponsive Non-Muscle Invasive Bladder Cancer (\"NMIBC\") Patients or Patients who are Intolerant to BCG Therapy\" was successfully launched in Canada at 4 clinical study sites (with 1 additional clinical study site in advanced negotiation) and now with FDA IND authorization, the Company plans to launch approximately 15 clinical study sites in the United States for a total of approximately 20 clinical study sites.Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of the Study Drug (TLD-1433, Theralase's patented PDC), in conjunction with the Study Device (TLC-3200 Medical Laser System) intended to deliver a safe and effective treatment (\"Study Treatment\") to patients inflicted with Carcinoma In-Situ (\"CIS\"), BCG-Unresponsive NMIBC.Study II is focused on enrolling and successfully treating approximately 100 CIS, BCG-Unresponsive NMIBC patients in approximately 20 clinical study sites located in Canada and the US.Study II has a:Primary endpoint of efficacy (measured by Complete Response (\"CR\")) at any point in timeSecondary endpoint of duration of CR at approximately 360 days post-initial CRTertiary endpoint of safety (measured by incidence and severity of adverse events grade 4 or higher that do not resolve within approximately 360 days post-initial treatment)In July 2019, Theralase signed an agreement with a urology Trial Management Organization (\"TMO\") to provide approximately 6 US-based study sites. In addition, the Theralase clinical study coordination team has identified and commenced the onboarding process for 9 other US based clinic...