Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) is aiming to leverage positive study data during 3Q into a Breakthrough Therapy designation from the US Food and Drug Administration.
The clinical-stage pharmaceutical company specializing in light and radiation-activated Photo Dynamic Compounds for cancer, bacteria, and virus treatment released positive preliminary clinical data from a Phase II study on bladder cancer in the quarter, indicating a 58% complete response at the 90-day assessment.
The study addresses patients diagnosed with Bacillus Calmette-Guérin (BCG)-Unresponsive, Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ, sometimes accompanied by resected papillary Ta/T1 disease. The treatment involves using a patented drug called Ruvidar, which is made with a material called ruthenium and put directly into the patient's bladder. To activate the drug, they also use a unique medical device called the TLC-3200 Medical Laser System. This device has a green laser and special lights that work together to activate the drug.
Theralase is hoping to develop a targeted and specific approach to treating the bladder cancer.
The study revealed promising outcomes: 63 patients received primary treatment, resulting in a 58% complete response at the 90-day assessment and a 35% complete response at 450 days.
The interim Kaplan-Meier curve data is positive, indicating over 80% of patients remaining in Study II after 90 days.
During 3Q, the group also submitted a pre-Breakthrough Designation (BTD) update to the FDA, and is planning to resubmit in 1Q 2024.
For the nine months ended September 30, 2023, Theralase reduced its net loss to $3.58 million year-to-date compared to $4.35 million at the same point in 2022.
Total revenue decreased by 13% year over year.