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FDA grants fast track designation to GC4419 for oral mucositis
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The FDA granted fast track designation to GC4419, an investigational therapy designed to reduce incidence and severity of radiation- and chemotherapy-induced oral mucositis.
Galera Therapeutics Inc. has started to enroll patients in a double blind, randomized phase 2b clinical trial.
Researchers will investigate whether GC4419 — administered in doses of either 30 mg or 90 mg before each radiation therapy fraction — reduces the incidence, duration and intensity of severe oral mucositis in patients with head and neck cancers.
Galera expects to enroll 200 patients across 55 sites in the United States.
“Coupled with our recently initiated phase 2b trial of GC4419, fast track [designation] offers the possibility to accelerate bringing this critical advance to head and neck cancer patients,” J. Mel Sorensen, MD, CEO of Galera, said in a company-issued press release. “If successful, GC4419 will not only reduce pain and suffering for [head and neck cancer] patients, but also improve their cancer treatment outcomes.”