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Theralase(R) Provides Update on Bladder Cancer Clinical Study
Interim clinical data has exceeded the recommended guidelines of the International Bladder Cancer...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Theralase(R) Provides Update on Bladder Cancer Clinical StudyInterim clinical data has exceeded the recommended guidelines of the International Bladder Cancer Group for complete response and duration of complete responseToronto, Ontario--(Newsfile Corp. - February 4, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) (\"Theralase®\" or the \"Company\"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses, is pleased to provide an update on the Phase II clinical study for bladder cancer. To date, 90 patients have been enrolled and treated with the Theralase® Study Procedure, achieving the patient enrollment specified by the statistical analysis plan.78 patients have completed the clinical study and were evaluated at all scheduled assessment visits or were prematurely removed by the principal investigator due to lack of response. There are 12 patients pending study completion.Primary Endpoint Performance (CR at any Point in Time)#%Confidence Interval (95%)Complete Response (\"CR\")56/8764.4%[48.6, 80.2]Total Response (CR and IR)64/8773.6%[56.7, 90.5] Note: Indeterminate Response (\"IR\") is defined as negative cystoscopy (no evidence of Urothelial Cell Carcinoma (\"UCC\") in the bladder) and positive / suspicious urine cytology (detection of cancer in the urine, without a negative confirmatory bladder biopsy, suggesting UCC in the renal system other than the bladder).Secondary Endpoint Performance (Duration of CR) (450 Days)#%Confidence Interval (95%)Complete Response19/4740.4%[23.8, 57.1]Total Response20/4742.6%[26.6, 58.5] Tertiary Endpoint Performance (Safety) (450 Days)#%Safety78/78100.0% Note: Theralase® believes all Serious Adverse Events (\"SAEs\") reported to date are unrelated or unlikely related to the Study Drug or Study Device.These results exceed the International Bladder Cancer Group's recommended guidelines of \"clinically meaningful initial complete response rates for carcinoma in situ of at least 50% at 6 months and 30% at 12 months.\"1Interim data from 47 patients indicates that complete response rates of 21.3% at both 2 and 3 years and 2.1% at 7 years were sustained.Theralase® will compile the clinical data in 2026 for p...