MALVERN, PA — 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, 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.”
Specifically, treatment with 90 mg avasopasem demonstrated statistically significant improvements (p<0.05) in return of kidney function to normal ranges after chemoradiotherapy, as measured by serum creatinine (sCr) levels between three and 24 months, estimated glomerular filtration rate (eGFR) between three and 24 months, and blood urea nitrogen (BUN) levels at three, six and 18 months, compared to placebo. A significant reduction (p<0.05) in the incidence of CKD at 12 months (GFR categories G3a-G5), compared to placebo, was also observed.
“This new analysis demonstrating an improvement in markers of kidney function following cisplatin therapy further strengthens the body of evidence for the potential of avasopasem to be an important part of the treatment armamentarium for cancer,” said Mel Sorensen, M.D., President and CEO of Galera. “We look forward to the continued evaluation of the potential of avasopasem in the reduction of chemoradiation-induced toxicities in our ongoing Phase 3 ROMAN trial for the treatment of SOM in head and neck cancer and our Phase 2a trial for the treatment of esophagitis in lung cancer.”
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