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Theralase(R) Completes Enrollment in Bladder Cancer Clinical Study
Toronto, Ontario--(Newsfile Corp. - February 2, 2026) - Theralase® Technologies Inc.  (...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Theralase(R) Completes Enrollment in Bladder Cancer Clinical StudyToronto, Ontario--(Newsfile Corp. - February 2, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) (\"Theralase®\" or the \"Company\"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, is pleased to announce that it has successfully completed its targeted milestone of enrolling and treating 90 patients in a multi-center Phase II clinical study for bladder cancer. The Phase II clinical study has a primary endpoint of efficacy, a secondary endpoint of duration of response and a tertiary endpoint of safety, in evaluating light-activated Ruvidar® in the treatment of patients diagnosed with Bacillus Calmette-Guérin (\"BCG\")-Unresponsive Non-Muscle Invasive Bladder Cancer (\"NMIBC\") Carcinoma In-Situ (\"CIS\"), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) (\"Study II\").The enrollment and treatment of 90 patients achieves the Company's statistical analysis plan and represents a significant step forward in evaluating a statistically and clinically significant dataset in support of a Health Canada and FDA regulatory approval. In accordance with the clinical protocol, Theralase® will enroll and treat any additional patients, who are in or pending screening.Pending Health Canada and FDA regulatory approval, light-activated Ruvidar® represents a potentially transformative, bladder-sparing treatment option for patients with limited alternatives, addressing a significant unmet need in high-risk NMIBC.Clinical data generated to date continues to demonstrate a strong efficacy, duration of response and favorable safety profile, with a majority of patients achieving durable responses with a single treatment.Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase®, stated, \"I am pleased that Theralase® has completed enrollment of 90 patients in its Phase II registrational clinical study for bladder cancer. This accomplishment allows the Company to complete this study in 2026 and prepare for Health Canada and FDA regulatory approval submissions.\"Roger...