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Galera Therapeutics announces presentation of analysis of Phase 3 ROMAN trial
The Fly

Galera Therapeutics announces presentation of analysis of Phase 3 ROMAN trial

Galera Therapeutics 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 in reducing the burden of severe oral mucositis. "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. We believe the results reinforce avasopasem’s first-in-class potential to reduce SOM, a common and debilitating effect of radiotherapy in patients with head and neck cancer. As we work with the FDA on the potential to bring avasopasem to U.S. patients, we also look forward to discussions with European regulatory authorities on a path for patients in Europe." Title: Net treatment benefit of avasopasem manganese for severe oral mucositis from the ROMAN trial. Results from two randomized, double-blind, placebo-controlled trials are the basis of the avasopasem NDA. The Company believes that the supplemental net treatment benefit analysis being presented at ECHNO further supports the avasopasem clinical benefit observed in those trials. It quantitatively demonstrates that the overall improvement in SOM is greater than that captured by any individual endpoint and that the improvement in each of the key SOM endpoints contributes to the benefit.

Published first on TheFly

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