GC4419 is a first-in-class, small molecule enzyme mimetic that converts superoxide to hydrogen peroxide and molecular oxygen. GC4419 is currently being evaluated in an ongoing randomized Phase 2 clinical trial to assess its effect on the incidence, severity and duration of severe oral mucositis (OM) when given to patients with squamous cell cancers of the head and neck in combination with radiation and chemotherapy.
GC4419 previously completed a Phase 1b/2a clinical trial and results are published in the International Journal of Radiation Oncology, Biology, Physics. In this study, compared to historic controls, GC4419 appeared to:
- Decrease severe OM incidence (WHO Grade 3+4)
- Delay severe OM onset
- Shorten severe OM duration
- Lessen significant radiation therapy treatment breaks
GC4419 was generally safe and well tolerated. Some patients experienced mild facial paresthesia. There was no evidence of tumor protection and the mechanism of action is thought to favor increasing tumor radiation response.1
GC4419 has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. For additional details on ongoing clinical trials with GC4419, please visit www.clinicaltrials.gov.