Theralase makes positive progress on Phase II study on bladder cancer; targets breakthrough designation with FDA
Vancouver
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December 04, 2023 01:16 PM Eastern Standard Time
Theralase Technologies Inc. CEO Roger DuMoulin-White, joined Proactive's Stephen Gunnion to discuss the company's third-quarter 2023 operational highlights.
The company successfully raised $1.17 million, crucial for advancing its Phase II clinical study targeting non-muscle invasive bladder cancer, particularly Bacillus Calmette-Guérin (BCG)-Unresponsive cases. The study's data shows promising superiority over FDA-approved drugs from major pharmaceutical companies, making it a groundbreaking development for Theralase.
DuMoulin-White detailed the unique approach, utilizing a drug-device combination involving a light-sensitive drug instilled into the bladder. This innovative method selectively targets cancer cells, minimizing damage to healthy cells, a departure from traditional pharmacological approaches.
Currently working on its pre-Breakthrough Therapy Designation (BTD) with the FDA, Theralase is aiming for formal BTD in early 2024.
Dumoulin-White highlighted the company's focus on non-dilutive financing, potential partnerships, and completing the primary study treatment for around 100 patients by the end of 2024. Successful completion could lead to an FDA decision, ideally by the end of 2026, potentially accelerated with priority review.
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