Theralase Updates on Bladder Cancer Clinical Study

Theralase Technologies Inc., a clinical-stage pharmaceutical company, has shared an update on its bladder cancer clinical study. This research focuses on Ruvidar™, a drug activated by the TLC-3200 Medical Laser System, aimed at treating Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer. This phase II registration study has enrolled 75 patients across Canada and the US.

The study reports a 60.3% complete response rate, comprising patients achieving this response at varying intervals up to 270 days. For a duration response of 450 days, the rate stands at 26.5%. Serious adverse events were reported in 14 patients, none linked to Ruvidar™ or TLC-3200 directly.

The research aligns with international guidelines, positing the Theralase study procedure as both safe and effective. The company is pursuing further FDA discussions for a Break Through Designation, seeking potential commercialization partners.