Posted by Michael Wonder on 23 Nov 2020
Theralase granted FDA fast track designation for NMIBC Phase 2 clinical study
23 November 2020 - Theralase Technologies announced today that the U.S. FDA has granted Theralase fast track designation for its Phase 2 Bacillus Calmette Guérin–unresponsive non-muscle invasive bladder cancer carcinoma in situ clinical trial.
The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system, to be the first intravesical patient-specific Ruthenium-based photodynamic compounds for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary Ta or T1 tumours.
