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Theralase Provides Company Update on Phase II Bladder Cancer Clinical Study
TORONTO, ON / ACCESSWIRE / March 20, 2020 / Theralase ® Technologies Inc. (" Thera...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Theralase Provides Company Update on Phase II Bladder Cancer Clinical StudyTORONTO, ON / ACCESSWIRE / March 20, 2020 / Theralase® Technologies Inc. (\"Theralase\" or \"Company\") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (\"PDC\") and associated drug formulations, has been notified by all of its Canadian clinical study sites that enrollment of new patients and conducting the first treatment procedure in the Company's Phase II Non-Muscle Invasive Bladder Cancer (\"NMIBC\") clinical study (\"Study II\") has been temporarily placed on hold pending resolution of the coronavirus (\"COVID-19\") global pandemic.Due to the global spread of COVID-19 and the uncertainty associated with the virus, the Company is in agreement with the clinical study site's decision and with provincial and federal government recommendations concerning social distancing, to minimize hospital admittance to only patients with an emergency need.The clinical study sites have elected to temporarily halt enrollment and first treatment of patients in Study II, pending resolution of COVID-19. The Company is in close contact with the clinical study sites and will continue to work in conjunction with them and the provincial and federal governments to monitor the situation to determine the best time to recommence enrollment and first treatment in Study II.The clinical study sites will however continue to monitor and treat patients already enrolled in Study II by providing:Continuous monitoring and clinical analysis during scheduled follow-up visitsSecond treatment procedureBodily fluid analysis, although this may be completed by a third-party organizationThe Canadian clinical study sites on temporary hold, include:University Health Network (\"UHN\"), Toronto, OntarioLondon Health Sciences Centre (\"LHSC\"), London, OntarioMcGill University Health Centre (\"MUHC\"), Montreal, QuebecNova Scotia Health Authority (\"NSHA\"), Halifax, Nova ScotiaStudy II Update:UHN and MUHC have enrolled and successfully treated 12 patients to date.FDA Investigational New Drug (\"IND\") Application Update:Theralase is in the process of responding to the Food and Drug Administration's (\"FDA\") questions regarding the Company's IND application. Subject to FDA's IND approval, Theral...