Theralase treats 90 patients in bladder cancer study

Executive Summary

• Theralase Technologies Inc. has completed the enrollment and treatment of 90 patients in its multicentre Phase II clinical study for bladder cancer, achieving the targeted milestone required for statistical analysis.
• The study evaluates light-activated Ruvidar for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS), a patient population with limited treatment alternatives facing radical cystectomy.
• Completion of this enrollment allows the company to finalize the study in 2026 and prepare regulatory submissions to Health Canada and the FDA, with plans to launch additional Phase I/II adaptive studies for other cancer types in 2026.

Key Details

• Study Milestone: Successfully enrolled and treated 90 patients in the Phase II registrational clinical study.
• Study Objectives:
  • Primary endpoint: Efficacy.
  • Secondary endpoint: Duration of response.
  • Tertiary endpoint: Safety.
• Target Population: Patients diagnosed with BCG-unresponsive NMIBC carcinoma in situ (CIS) who have failed standard-of-care therapy.
• Treatment Protocol: Utilizes the therapeutic dose of the small molecule Ruvidar, activated by the TLC-3200 medical laser system.
• Study Sites: 12 clinical study sites located in Canada and the United States.
• Current Data: Clinical data to date demonstrates strong efficacy, duration of response, and a favorable safety profile, with a majority of patients achieving durable responses with a single treatment.
• Regulatory Path: Data supports preparation for Health Canada and FDA regulatory approval submissions.
• Future Pipeline:
  • Completion of the bladder cancer study in 2026.
  • Launch of a combinational clinical study for bladder cancer.
  • Launch of numerous Phase I/II adaptive clinical studies for brain, lung, muscle-invasive bladder, pancreatic, and colorectal cancers.
• Market Context: In the US, bladder cancer is the sixth-most common cancer; approximately 75% of cases present as NMIBC, and current options for BCG-unresponsive patients are limited, often requiring cystectomy.

Notable Quotes

• Dr. Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer: "I am pleased that Theralase has completed enrolment 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 DuMoulin-White, BSc, PEng, ProDir, President and CEO: "Enrolling and treating 90 patients in our phase II registration clinical study represents a significant milestone for the company. With the targeted enrolment now completed, we can focus on compilation of the clinical data for Health Canada and FDA regulatory approval. Two thousand twenty-six will be a pivotal year for the company as we complete our bladder cancer study, embark on a combinational clinical study for bladder cancer, and launch numerous phase I/II adaptive clinical studies for brain, lung, muscle-invasive bladder, pancreatic and colorectal cancers."