Galera Announces Presentation of Phase 3 ROMAN Long-term Follow-up Data at 2022 American ...
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 one-year tumor and renal function outcomes data from its Phase 3 ROMAN trial of avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM), as well as topline results from a recently completed meta-analysis of the ROMAN and GT-201 SOM trial results, at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting. Final data from its Phase 2 AESOP trial of avasopasem for radiotherapy-induced esophagitis were also presented today in a separate session. In addition, poster presentations during ASTRO highlighted the completed Phase 2 EUSOM trial of avasopasem for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer
By Galera Therapeutics
Published - Oct 26, 2022, 01:45 PM ET
Last Updated - Apr 23, 2024, 11:23 AM EDT
Tumor outcomes and overall survival maintained in patients with HNC at one-year
Cisplatin-related chronic kidney disease reduced by 50% in avasopasem patients compared to placebo at one-year
Meta-analysis of ROMAN and GT-201 (Phase 2b) supports efficacy across trials and key SOM endpoints
Company remains on track to submit NDA to the U.S. FDA for avasopasem for radiotherapy-induced severe oral mucositis by end of 2022