Galera Therapeutics Announces Publication of GC4419 Data in the Journal of Clinical Oncology

- GC4419 90 mg produced clinically meaningful reduction of severe oral mucositis duration, incidence and severity in Phase 2b clinical trial -

MALVERN, Pa., Dec. 05, 2019 (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 full results from the 223-patient, randomized, double-blind Phase 2b clinical trial of lead candidate GC4419 (avasopasem manganese) in patients with locally advanced head and neck cancer have been published in the Journal of Clinical Oncology, a journal of the American Society of Clinical Oncology (ASCO).

Data in the paper, titled, “Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer,” demonstrated that adding a 90 mg dose of GC4419 to a standard radiotherapy regimen produced a significant reduction of severe oral mucositis (SOM) duration from 19 days to 1.5 days (92 percent), and improvement in SOM incidence through completion of radiation by 34 percent and improvement in oral mucositis (OM) severity (Grade 4 OM incidence) by 47 percent.

Carryn Anderson, M.D., Radiation Oncologist, University of Iowa Hospitals and Clinics, and lead investigator, said, “The clinically meaningful Phase 2b data highlight the potential of GC4419 to address a serious unmet need for a therapy to reduce the incidence and severity of radiation-induced severe oral mucositis, for which there is currently no FDA-approved drug. I look forward to the results of the pivotal ongoing ROMAN clinical trial which will potentially reinforce these promising findings.”

“We are pleased that our GC4419 Phase 2b data have been published in the preeminent peer-reviewed oncology journal. These data, like the data previously presented at ASCO, ASTRO and MASCC, reinforce GC4419’s potential to make a meaningful difference for head and neck cancer patients suffering from severe oral mucositis, a debilitating toxicity,” said Mel Sorensen, M.D., President and CEO of Galera. “Enrollment in our Phase 3 ROMAN clinical trial of GC4419 in patients with locally advanced head and neck cancer continues, and we anticipate reporting topline data in the first half of 2021.”