TLTFF - Theralase makes positive progress on Phase II study on bladder cancer; targets breakthrough designation with FDA

(NewsDirect)

Theralase Technologies Inc. CEO RogerDuMoulin-White, joined Proactive's Stephen Gunnion to discuss thecompany's third-quarter 2023 operational highlights.

The company successfully raised $1.17million, crucial for advancing its Phase II clinical study targetingnon-muscle invasive bladder cancer, particularly BacillusCalmette-Guérin (BCG)-Unresponsive cases. The study's data showspromising superiority over FDA-approved drugs from majorpharmaceutical companies, making it a groundbreaking development forTheralase.

DuMoulin-White detailedthe unique approach, utilizing a drug-device combination involving alight-sensitive drug instilled into the bladder. This innovativemethod selectively targets cancer cells, minimizing damage to healthycells, a departure from traditional pharmacological approaches.

Currently working on its pre-BreakthroughTherapy Designation (BTD) with the FDA, Theralase is aiming for formalBTD in early 2024.

Dumoulin-White highlighted the company'sfocus on non-dilutive financing, potential partnerships, andcompleting the primary study treatment for around 100 patients by theend of 2024. Successful completion could lead to an FDA decision,ideally by the end of 2026, potentially accelerated with priorityreview.

Contact Details

ProactiveInvestors

+1 604-688-8158

na-editorial@proactiveinvestors.com

Copyright (c) 2023 TheNewswire - All rights reserved.