Galera Therapeutics Announces Avasopasem Manganese Improved Markers of Chronic Kidney Disease in Patients Receiving Cisplatin

Retrospective analysis of patients with head and neck cancer treated in Phase 2b clinical trial of avasopasem manganese presented at ASCO 2020 Virtual Scientific Program

MALVERN, Penn., May 29, 2020 (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 new data from a retrospective analysis of pre- and post-treatment markers of kidney function of patients treated with lead candidate avasopasem manganese in its Phase 2b trial for the reduction of chemoradiation-induced severe oral mucositis (SOM). The data are featured in an American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program poster presentation now available for on-demand viewing in ASCO’s virtual program.

Avasopasem is a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced toxicity severe oral mucositis (SOM). Galera’s completed Phase 2b clinical trial evaluated avasopasem in patients with locally advanced head and neck cancer. Patients in the trial received seven weeks of concurrent radiation therapy and cisplatin, the current standard of care for head and neck cancer patients, plus either 30 mg or 90 mg of avasopasem or placebo.

Each year in the United States, approximately 65,000 patients are diagnosed with head and neck cancer, according to the American Cancer Society, and nephrotoxicity from cisplatin-based chemotherapy occurs in up to 68 percent of head and neck cancer patients treated.

The retrospective analysis evaluated changes in kidney function markers in a subset of 52 Phase 2b trial participants and 7 matched comparator patients who all received high dose (100 mg/m²) cisplatin once every three weeks. Post-treatment kidney function markers indicated patients who received 90 mg avasopasem had significantly less cisplatin-induced chronic kidney disease (CKD) compared to placebo.

“Cisplatin, which is commonly used as part of the treatment regimen for patients with head and neck cancer, is associated with robust survival outcomes, but its use can be limited due to nephrotoxicity. There is a serious and unmet need for therapies to prevent or minimize kidney injury associated with cisplatin in order to sustain the survival benefit and ensure clinicians are able to optimize the clinical utility of chemotherapies, including platinum agents, for the up to 40 percent of head and neck cancer patients that develop a loco-regional recurrence,” said Bryan Allen, M.D., Ph.D., Radiation Oncologist, University of Iowa Hospitals & Clinics. “The effect of avasopasem on markers of chronic kidney disease is an exciting preliminary finding and warrants continued study.”