On September 8, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer, reported final results from its Phase 1/2 pilot trial of its dismutase mimetic, GC4419, versus placebo, in patients with unresectable or borderline resectable locally advanced pancreatic cancer (LAPC), who are undergoing stereotactic body radiation therapy (SBRT) (Press release, Galera Therapeutics, SEP 8, 2021, View Source [SID1234587531]). The results include a minimum of one year of follow up on all 42 patients enrolled in the trial.

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In this proof-of-concept trial, improvements were observed in overall survival (HR=0.48; 95% CI: 0.20-1.14; p=0.090), progression-free survival (HR=0.46; 95% CI: 0.22-0.98; p=0.040), local tumor control (HR=0.30; 95% CI: 0.08-1.10; p=0.055) and time to distant metastases (HR=0.39; 95% CI: 0.16-0.93; p=0.028). 46% of patients in the active arm were alive at last follow-up (11 out of 24) compared to 33% in the placebo arm (6 out of 18). As previously reported, 29% of patients in the active arm achieved a 30% or greater decrease in primary tumor size (partial response) compared to 11% of patients in the placebo arm. GC4419 was well tolerated, with similar rates of early and late adverse events in the active and placebo arms. For more information related to this trial, please see the Company’s updated corporate presentation on the Investors page of Galera’s website at investors.galeratx.com.

"We are very pleased with the survival and tumor outcome benefits observed in the final analysis of this proof-of-concept trial," said Mel Sorensen, M.D., President and CEO of Galera. "The improvements across multiple efficacy parameters, together with the safety data, are encouraging and underpin the rationale for our 160-patient blinded, randomized GRECO-2 trial of GC4711 with SBRT in pancreatic cancer, where the primary endpoint is overall survival. These are exciting times for Galera as we also look forward to announcing topline data from our ROMAN Phase 3 trial for the reduction of severe oral mucositis in patients with head and neck cancer later this year."

"We are excited to see the final results from this trial and enthusiastic to participate in the Phase 2b GRECO-2 trial," said Sarah Hoffe, M.D., Section Head of GI Radiation Oncology at H. Lee Moffitt Cancer Center and Research Institute. "These observed overall survival rates are particularly encouraging in pancreatic cancer, as this patient population faces a difficult diagnosis with high rates of distant metastasis and low rates of cure."

Galera’s selective dismutase mimetic product candidates are small molecules being developed to protect normal cells and sensitize cancer cells to radiotherapy. The Phase 1/2 pilot trial was a randomized, double-blind, multicenter, placebo-controlled trial in 42 patients diagnosed with LAPC evaluating the safety and efficacy of SBRT and the dismutase mimetic, GC4419, compared to SBRT and placebo. Patients were randomized (1:1) to receive GC4419 or placebo by intravenous infusion one hour prior to SBRT.

GRECO-2 is a randomized, double-blind, placebo-controlled Phase 2b trial evaluating Galera’s second dismutase mimetic product candidate, GC4711, compared to placebo in patients with LAPC undergoing SBRT. The trial was initiated in May 2021 and is expected to enroll approximately 160 patients. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, local tumor control, time to distant metastases and surgical resection rate, in addition to safety.