Primary endpoint of reduction in incidence of severe oral mucositis (SOM) not met
Trial demonstrated relative reduction in all key SOM endpoints, including more than halving the median duration
Avasopasem was generally well tolerated compared to placebo
MALVERN, Pa., Oct. 19, 2021 (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 results from the Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The trial did not meet its primary endpoint of reduction in the incidence of SOM. The Company is continuing to analyze the results.
“While the data, as in previous trials, showed reductions in the incidence, duration and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint,” said Mel Sorensen, M.D., Galera’s President and CEO. “We would like to extend our heartfelt thanks to the patients who participated in this trial while they underwent radiotherapy for head and neck cancer. As we evaluate next steps for this program, we remain committed to our goal of transforming radiotherapy in cancer treatment with our selective dismutase mimetics.”
Key...
Read Full Story: https://finance.yahoo.com/news/galera-announces-results-phase-3-110000634.html
Your content is great. However, if any of the content contained herein violates any rights of yours, including those of copyright, please contact us immediately by e-mail at media[@]kissrpr.com.