Theralase(R) Provides Update on Bladder Cancer Clinical Study

Executive Summary

• Theralase® Technologies reports that its Phase II bladder cancer study met enrollment targets (90 patients) and achieved a primary endpoint complete response rate of 64.4% (56/87), exceeding International Bladder Cancer Group guidelines.
• Total response (complete + indeterminate) reached 73.6% (64/87). Secondary analysis shows durable complete responses in 40.4% of patients at 12‑month follow‑up.
• Safety was favorable, with no serious adverse events attributed to the study drug/device among all 78 evaluable patients.

Key Details

• Enrollment: 90 patients enrolled; 78 completed the study; 12 pending completion.
• Primary Endpoint (CR at any time): 56/87 patients → 64.4% (95 % CI: 48.6‑80.2%).
• Total Response (CR + IR) Primary: 64/87 patients → 73.6% (95 % CI: 56.7‑90.5%).
• Secondary Endpoint (Duration of CR, 450 days):
• Complete response sustained in 19/47 patients → 40.4% (95 % CI: 23.8‑57.1%).
• Total response sustained in 20/47 patients → 42.6% (95 % CI: 26.6‑58.5%).
• Tertiary Endpoint (Safety, 450 days): 78/78 patients reported no study‑related serious adverse events (100 % safety).
• Interpretation: Results surpass the International Bladder Cancer Group’s benchmark of ≥50 % CR at 6 months and ≥30 % CR at 12 months for carcinoma in situ.
• Long‑term Follow‑up (interim data, n=47): Sustained complete response rates of 21.3 % at both 2‑ and 3‑year marks; 2.1 % at 7 years.
• Regulatory Path: Clinical data to be compiled in 2026 for submission to Health Canada and the U.S. FDA, with anticipated regulatory approval in 2027.

Notable Quotes

(No direct quotes were provided in the release.)