Theralase Expands Bladder Cancer Clinical Trial with New Sites and Promising Phase II Data

Key Insights

• Theralase has launched new clinical study sites in the U.S. and Canada for its Phase II trial of Ruvidar™ in BCG-unresponsive NMIBC.
• Phase II data shows a 61.9% complete response rate among patients, with 43.6% maintaining this response for at least 12 months.
• The treatment has demonstrated a strong safety profile, with 100% of patients experiencing no serious adverse events related to the therapy.

Theralase Technologies Inc. (TSXV:TLT)(OTCQB:TLTFF) is advancing its Phase II registration study for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with the opening of new clinical study sites in both the United States and Canada. The trial investigates Ruvidar™ (TLD-1433), a drug activated by the TLC-3200 Medical Laser System.

Clinical Trial Expansion

St. Joseph's Healthcare Hamilton has become the latest Canadian site, while Associated Medical Professionals of NY, Urology of Indiana, and Central Ohio Urology Group have been added in the U.S. These additions bring the total number of North American clinical study sites to 14, with more planned for early 2025.

Promising Phase II Results

Data from 75 enrolled patients in Study II indicate a 61.9% complete response (CR) rate [42.5, 81.3]. When including patients with an indeterminate response (IR), the total response (TR) rate increases to 68.3% [47.9, 88.7].

Regarding the duration of response, 43.6% [22.9, 64.3] of patients who achieved a CR maintained it for at least 12 months. Some patients have shown continued response at 24 and 36 months. Notably, the treatment has demonstrated a 100% safety profile, with no serious adverse events (SAEs) reported.

Expert Commentary

Bobby Shayegan MD, FRCSC, Head of Urology at St. Joseph's Healthcare Hamilton, expressed enthusiasm for the technology, noting its potential to effectively treat bladder cancer while preserving patients' quality of life compared to radical cystectomy. Christopher Pieczonka, MD, CEO of Associated Medical Professionals of NY, echoed this sentiment, highlighting the strong efficacy, duration, and safety profile observed in the clinical data.

Ruvidar™ Mechanism and Future Plans

Ruvidar™ (TLD-1433) is Theralase's lead drug, activated by the TLC-3200 Medical Laser System. The treatment involves intravesical installation of Ruvidar™ followed by laser activation. Theralase is seeking partnerships for the international commercialization of Ruvidar™ and anticipates regulatory approval in 2026.