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Theralase's 5th Annual Medical and Scientific Advisory Board Meeting Advances Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
TORONTO, ON / ACCESSWIRE / May 13, 2019 / Theralase® Technologies Inc. (" Theralase " o...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Theralase’s 5th Annual Medical and Scientific Advisory Board Meeting Advances Phase II Non-Muscle Invasive Bladder Cancer Clinical StudyTORONTO, ON / ACCESSWIRE / May 13, 2019 / Theralase® Technologies Inc. (\"Theralase\" or the \"Company\") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds (\"PDC\") and their associated drug formulations intended to safely and effectively destroy various cancers announced that Theralase recently met with its Medical and Scientific Advisory Board (\"MSAB\"), as well as potential Principal Investigators (\"PIs\"), who are interested in participating in the Phase II Non-Muscle Invasive Bladder Cancer (\"NMIBC\") clinical study (\"ACT-NMIBC\").The meeting focused primarily on the presentation of the clinical endpoints achieved in the successfully completed Phase Ib NMIBC clinical study, as well as a discussion on the design and FDA regulatory requirements pertaining to the ACT-NMIBC.The FDA provided guidance to the industry in February 2018, entitled, \"BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry\".In the guidance, the FDA stated that, \"In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application.\" 1Theralase's primary question to be discussed with the FDA during a pre-Investigational New Drug (\"pre-IND\") conference call to be held in early 3Q2019 will be \"If Theralase's ACT-NMIBC demonstrates a Complete Response (\"CR\") at 90 days and a duration of that CR of 30% or more at 360 days post primary treatment, would this be sufficient to support a marketing application in the opinion of the FDA?\"The PIs at the meeting consisting of leading Canadian, US and international uro-oncologists, were presented with the opportunity to learn more about Theralase's TLD-1433-based PhotoDynamic Therapy (\"PDT\") and its application to BCG-Unresponsive NMIBC.Dr. Shawn Shirazi, CEO-Drug Division, Theralase stated, \"Theralase stakeholders should be excited about the ability of the Company to execute on its strategic objectives, from successfully completing the Phase Ib NMIBC ...