Theralase Technologies talks bladder cancer study results

Executive Summary

• Theralase Technologies reports that the Phase II bladder cancer study has enrolled the planned 90 patients, with 78 having completed the trial.
• Interim data from 47 patients show sustained complete response (CR) rates of 21.3 % at both two and three years, exceeding International Bladder Cancer Group guidelines for meaningful CR rates.
• The company plans to compile full clinical data in 2026 for submission to Health Canada and the U.S. FDA, targeting regulatory approval in 2027.

Key Details

• Enrollment & Completion: 90 patients enrolled; 78 completed (or were removed due to lack of response); 12 pending completion.
• Guideline Comparison: Exceeds recommended initial CR rates of ≥50 % at six months and ≥30 % at twelve months for carcinoma in situ.
• Interim Efficacy Results (47 patients):
• Complete response rate: 21.3 % sustained at 2‑year and 3‑year marks.
• Long‑term CR rate: 2.1 % at seven years.
• Regulatory Timeline: Full data compilation slated for 2026; submission to Health Canada and FDA anticipated, with expected approval in 2027.
• Study Endpoints:
• Primary – efficacy (any-time complete response).
• Secondary – durability of CR ≥12 months.
• Tertiary – safety (serious adverse events persisting >450 days).
• Study Procedure: Light‑activated Ruvidar administered to BCG‑unresponsive non‑muscle‑invasive bladder cancer (NMIBC) CIS patients who have failed standard therapy.

Notable Quotes

(No direct quotes were provided in the release.)