Galera to Present One-Year Reductions in Cisplatin-Related Chronic Kidney Disease Data from ROMAN Trial at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Rhea-AI Summary

Galera Therapeutics (Nasdaq: GRTX) announced a significant finding from the Phase 3 ROMAN trial that focuses on reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck cancer. This analysis will be presented at the 2023 ASCO Annual Meeting scheduled for June 2-6, 2023 in Chicago, IL. The presentation, titled One-year reductions in CKD in patients with HNC cancer treated with avasopasem manganese, is set for June 5, 2023, from 1:15 PM to 4:15 PM ET. Avasopasem is currently under priority review by the FDA for severe oral mucositis, with a decision expected by August 9, 2023.

MALVERN, Pa., April 26, 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 that a prespecified analysis from the Phase 3 ROMAN trial detailing one-year reductions in cisplatin-related chronic kidney disease in patients with head and neck cancer treated with avasopasem will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023, in Chicago, IL.

Presentation Details:

Title: One-year reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck (HNC) cancer treated with avasopasem manganese: A prespecified analysis from the phase 3 ROMAN trial
Abstract Number: 6066
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 5, 2023, 1:15 PM – 4:15 PM ET

The titles of the abstracts are currently available in the ASCO digital program, with the full abstracts scheduled to be published on May 25, 2023, at 5 p.m. ET. The presentation will be available on Galera’s website at the start of the poster session at https://www.galeratx.com/our-pipeline/key-publications.

About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem, or GC4419) is being developed for radiation-induced toxicities. A New Drug Application (NDA) for avasopasem is currently under priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee (PDUFA) date of August 9, 2023 for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. The Company’s second product candidate, rucosopasem manganese (rucosopasem, or GC4711), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA.

Investor Contacts:
Christopher Degnan
Galera Therapeutics, Inc.
610-725-1500
cdegnan@galeratx.com

William Windham
Solebury Strategic Communications
646-378-2946
wwindham@soleburystrat.com

Media Contact:
Zara Lockshin
Solebury Strategic Communications
330-417-6250
zlockshin@soleburystrat.com

FAQ

What does the Phase 3 ROMAN trial reveal about GRTX?

The Phase 3 ROMAN trial shows significant one-year reductions in cisplatin-related chronic kidney disease in head and neck cancer patients treated with avasopasem.

When will the findings from the ROMAN trial be presented?

The findings will be presented at the 2023 ASCO Annual Meeting on June 5, 2023, from 1:15 PM to 4:15 PM ET.

What is the focus of Galera Therapeutics (GRTX)?

Galera Therapeutics is focused on developing therapeutics that aim to transform radiotherapy for cancer treatment, particularly for reducing radiotherapy-induced toxicities.

What is the FDA status of avasopasem by GRTX?

Avasopasem is currently under priority review by the FDA, with a decision expected by August 9, 2023.

Where and when is the 2023 ASCO Annual Meeting?

The 2023 ASCO Annual Meeting is scheduled for June 2-6, 2023, in Chicago, IL.