Theralase Technologies CEO Roger DuMoulin-White joined Steve Darling from Proactive to share updates on the company's ongoing Phase II registration study for its lead drug, Ruvidar, used in combination with the TLC-3200 Medical Laser System. The study is focused on treating Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) in both Canada and the United States.
The clinical trial, a single-arm, open-label study, follows FDA guidelines and involves the intravesical installation of reconstituted Ruvidar followed by activation with the TLC-3200 Medical Laser. So far, 75 patients have been enrolled and have undergone the primary study procedure. The interim analysis results are promising, showing a 60.3% Complete Response (CR) rate at any point in time, which includes 37 patients achieving CR at 90 days, 3 at 180 days, and 1 at 270 days.
For the secondary objective, a CR of 26.5% was achieved at 450 days. While these results are encouraging, DuMoulin-White emphasized that the data is still interim, as the clinical study is ongoing, and more data is expected as the trial progresses.