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 were presented at the 2016 Annual Meeting of the American Society of Radiation Oncology (ASTRO). 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 fast track designations from the U.S. Food and Drug Administration. For additional details on clinical trials with GC4419, please visit www.clinicaltrials.gov.

icon_clinicalA Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer [ongoing]

icon_clinicalA Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck

Reference:
1. Anderson CM, Allen BG, Sun W, et al. Phase 1b trial of superoxide (SO) dismutase (SOD) mimetic GC4419 to reduce chemoradiation therapy (CRT)-induced oral mucositis (OM) in patients (pts) with oral cavity or oropharyngeal carcinoma (OCC). Int J Radiat Oncol. 2016;96(2):S83-S84.