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Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology

Excerpt from the Press Release:

MALVERN, Pa., March 10, 2023 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the presentation of a net treatment benefit analysis of Phase 3 ROMAN results at the 10th European Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal. The analysis further demonstrates the overall impact of avasopasem manganese (avasopasem) in reducing the burden of severe oral mucositis (SOM). Galera’s New Drug Application (NDA) in the U.S. for avasopasem is currently under U.S. Food and Drug Administration (FDA) priority review for radiotherapy (RT)-induced SOM in patients with head and neck cancer undergoing standard-of-care treatment.

“We are pleased to present at ECHNO the results of the Phase 3 ROMAN trial, including a net treatment benefit analysis submitted as part of Galera’s NDA,” said Mel Sorensen, M.D., President and Chief Executive Officer of Galera Therapeutics. “This analysis is particularly appropriate for SOM, where we believe that no single endpoint fully characterizes the potential impact of SOM on patient quality of life.

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