Galera Therapeutics Announces New Data from the Phase 2b Trial

Galera Therapeutics

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, announced a retrospective analysis of Phase 2b trial data demonstrating the potential renal protective activity of lead candidate avasopasem manganese (GC4419), and two ongoing clinical trials evaluating avasopasem, will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. Abstracts are available now in the ASCO digital program, and presentations will be available for on-demand viewing on May 29, 2020, at 8 a.m. EDT.

“We look forward to sharing important clinical updates that underscore the potential of avasopasem to address radiation-induced toxicities and enhance the anti-cancer efficacy of chemoradiotherapy,” said Mel Sorensen, M.D., President and CEO of Galera. “We’re particularly excited to share, for the first time, new data supporting avasopasem’s potential to improve chronic kidney disease markers in patients treated with cisplatin, a commonly used chemotherapy for cancer treatment. These data came from patients with head and neck cancer enrolled in our completed Phase 2b trial for the reduction of radiation-induced severe oral mucositis (SOM). In head and neck cancer treatment, where cisplatin is a mainstay, avasopasem may have the ability to prevent or mitigate two devastating toxicities of chemoradiotherapy – radiation-induced SOM and cisplatin-induced kidney damage.”

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For the retrospective analysis (abstract 12071), pre- and post-treatment markers of kidney function were evaluated for a subset of patients from Galera’s completed Phase 2b trial of avasopasem for the reduction of radiation-induced SOM in patients with locally advanced head and neck cancer. Patients in the trial received seven weeks of radiation therapy plus cisplatin, and were treated with either 30 mg or 90 mg of avasopasem or placebo. Kidney function markers indicate that treatment with the higher dose 90 mg avasopasem significantly reduced the incidence and severity of cisplatin-induced chronic kidney disease compared to placebo.

“Chronic kidney disease is an underrecognized long-term complication of platinum-based chemotherapy occurring in up to 36 percent of patients with cancer receiving it and there is no medication to prevent or minimize it,” said Diana Zepeda-Orozco, M.D., Nephrologist, Nationwide Children’s Hospital. “These data indicate a promising dose-dependent protective effect of avasopasem that results in reduced incidence and severity of chronic kidney disease after chemotherapy, and further study is warranted.”

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In addition to the chronic kidney disease data, two additional trial-in-progress (TIP) posters were selected for presentation during the virtual program. The abstracts describe the ongoing Phase 3 ROMAN clinical trial of avasopasem for the reduction of radiation-induced SOM in patients with locally advanced head and neck cancer receiving radiotherapy plus cisplatin (abstract TPS6596), and the ongoing pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (abstract TPS4670). Galera expects to present topline data from the pancreatic cancer trial in the second half of 2020, and from the ROMAN head and neck cancer trial in the second half of 2021.

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