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, this week announced the first patient has been dosed in a Phase 2a clinical trial of lead product candidate avasopasem manganese (GC4419) to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer.
The open-label, multi-center trial will evaluate the efficacy of avasopasem manganese, a highly selective small molecule superoxide dismutase (SOD) mimetic, in reducing the incidence of severe (Grade 2 or worse on the NCI Common Terminology Criteria for Adverse Events scale) acute radiation-induced esophagitis in patients with lung cancer receiving chemoradiotherapy. Approximately 60 adult patients with pathologically confirmed unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers will be enrolled at approximately 10 sites. Patients in the trial will receive 90 mg of avasopasem manganese by infusion on the days they receive their radiation therapy.
“Radiation-induced esophagitis is a common, debilitating side effect that can delay or prevent curative cancer treatment, and no FDA-approved therapies to treat it currently exist,” said Lawrence Berk, M.D., Ph.D., Professor of Radiation Oncology at the University of South Florida and lead investigator of the Phase 2a trial. “The initiation of this trial is a critical step toward addressing this urgent unmet need for a treatment option. The results of the Phase 2b trial of avasopasem manganese which demonstrated its ability to reduce the incidence of radiation-induced severe oral mucositis – another debilitating radiotherapy side effect – in patients with head and neck cancer support the further evaluation of avasopasem manganese for the treatment of other related radiation toxicities like esophagitis.”
There are approximately 230,000 new lung cancer patients diagnosed annually in the United States, and approximately 50,000 of those are treated with radiation therapy. Esophagitis, or mucositis of the esophagus, is a common and painful complication of radiation therapy for lung cancer. Symptoms can be life-threatening and include an inability to swallow, severe pain, ulceration, infection, bleeding and weight loss, and may require hospitalization.
“We’re pleased to expand the evaluation of avasopasem manganese into a second radiation toxicity, esophagitis, in patients with lung cancer,” said Mel Sorensen, M.D., President and CEO of Galera. “Galera is committed to improving the quality of life for patients suffering from cancer. This trial will broaden our understanding of the utility of avasopasem manganese in the treatment of radiotherapy toxicities beyond our first indication, radiation-induced severe oral mucositis in patients with head and neck cancer.”
Source: Galera Therapeutics, Inc., 2 West Liberty Blvd., Suite 110, Malvern, PA 19355
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