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 full tumor outcomes results from the two-year follow-up of patients with head and neck cancer treated with avasopasem manganese (GC4419), Galera’s lead product candidate for severe oral mucositis (SOM), in a Phase 2b clinical trial.
“There is currently no drug to prevent or treat SOM, one of the most common and disruptive side effects of radiation therapy that severely impacts both a patient’s quality of life and treatment experience,” said Mel Sorensen, M.D., President and CEO of Galera Therapeutics. “Avasopasem manganese’s efficacy and tumor outcomes in SOM underscore its potential to complement a standard radiation therapy regimen and change the standard of care for the reduction of SOM in patients with head and neck cancer receiving radiotherapy. We look forward to the continued evaluation of avasopasem manganese for the treatment of SOM in our ongoing Phase 3 ROMAN trial, as well as for other radiation-induced toxicities, such as esophagitis in lung cancer in our ongoing Phase 2a trial.”
Avasopasem manganese is a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced SOM defined by the World Health Organization as Grade 3 or 4, a common side effect characterized by significant pain and the inability to eat solid food or drink liquids. Galera’s completed Phase 2b clinical trial evaluated avasopasem manganese in patients with locally advanced head and neck cancer. Patients in the trial received seven weeks of radiation therapy plus cisplatin, and were treated with either 30 mg or 90 mg of avasopasem manganese or placebo by infusion on the days they received their radiation treatment.
As part of the trial, Galera assessed tumor outcomes of the patients over a two-year period following radiation therapy. At both the one-year interim assessment and final two-year mark, tumor outcomes were maintained in both avasopasem manganese dose groups compared to placebo. Specifically, outcomes for the 90 mg dose group, the dose currently being evaluated in the ongoing Phase 3 ROMAN trial, were comparable to placebo across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival.
“Radiation-induced toxicities like SOM are prevalent and debilitating complications of cancer treatment,” said Carryn Anderson, M.D., Radiation Oncologist, University of Iowa Hospitals and Clinics, and lead investigator. “SOM in head and neck cancer patients, in particular, may be associated with dose reductions and / or radiation treatment breaks which can limit the antitumor efficacy of radiation therapy and impede successful tumor management. The tumor outcomes resulting from treatment with avasopasem manganese were consistent with expectations for concurrent intensity-modulated radiation therapy (IMRT)/cisplatin in patients with head and neck cancer and demonstrate avasopasem manganese’s potential to mitigate this devastating side effect while maintaining radiation efficacy.”
Trial results previously disclosed also demonstrated that adding a 90 mg dose of avasopasem manganese to a standard radiotherapy regimen produced a statistically significant reduction in duration of SOM from 19 days to 1.5 days (92 percent), and clinically meaningful reductions in SOM incidence through completion of radiation by 34 percent and in the severity of oral mucositis (OM) (incidence of Grade 4 OM) by 47 percent.
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