Galera Therapeutics Announces Positive Interim Data from First Cohort of Patients in Pilot Phase 1/2 Clinical Trial of GC4419 in Pancreatic Cancer

Interim data on first 19 patients released in ASTRO Annual Meeting late-breaker presentation abstract showed improvement in overall survival and multiple anti-cancer efficacy measures

Interim data from full patient population to be presented during ASTRO Late-breaking Special Session October 27

MALVERN, Pa., Oct. 23, 2020 (GLOBE NEWSWIRE) -- 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, today announced the release of the abstract containing interim data from the first 19 patients in its pilot Phase 1/2 clinical trial designed to evaluate the safety and efficacy of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT), compared with SBRT and placebo, in patients with locally advanced pancreatic cancer (LAPC).

The interim data were shared in abstract #LBA5 on the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting virtual program website. Galera’s investigational, highly selective small molecule superoxide dismutase (SOD) mimetics are designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen. These dismutase mimetics have potential anti-cancer synergy based on positive results in multiple preclinical models.

In the initial analysis of the intent-to-treat cohort (n=19) enrolled in the first, single-center stage of the trial, which comprises all patients followed for over a year, median overall survival (OS) had not yet been reached in the GC4419 arm, compared to 40.4 weeks (HR=0.3; 95% CI 0.09-1.05; p=0.046) in the placebo arm. The GC4419 arm also demonstrated favorable progression-free survival, locoregional control and time-to-distant metastases compared to the placebo arm. The incidence of acute (<90 days) or late (91-365 days) Grade 3+ toxicity post-SBRT was similar in both arms.

“LAPC is a devastating diagnosis with limited treatment options. By combining our investigational dismutase mimetics with SBRT, we believe we have an opportunity to improve tumor response and survival outcomes. This is the first clinical data assessing the anti-cancer activity of one of our dismutase mimetics, and we are encouraged by this analysis of the initial cohort which suggests a meaningful survival benefit in pancreatic cancer,” said Mel Sorensen, M.D., President and CEO of Galera. “We look forward to presenting the interim data from the full patient population in this pilot trial on October 27.”