Galera Therapeutics Completes Enrollment of Phase 1b/2a Clinical Trial of GC4419 in Combination with Radiotherapy for Locally Advanced Pancreatic Cancer

Topline safety and efficacy data to be reported in the second half of 2020

MALVERN, Pa., July 13, 2020 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary small molecule therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has completed patient enrollment in its pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).

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 supported by positive results in multiple preclinical models. The randomized Phase 1b/2a trial is evaluating the safety, progression-free survival and overall response rate of GC4419 in combination with SBRT, compared with SBRT and placebo, in LAPC patients. The trial is also assessing safety and tolerability to determine the recommended dose of SBRT when combined with GC4419 or placebo.

“Pancreatic cancer has one of the poorest survival prognoses of common cancers and better treatments are urgently needed. Even when the disease is locally advanced, treatment options have limited impact on this difficult-to-treat cancer,” said Mel Sorensen, M.D., President and CEO of Galera. “This pilot trial is the first to evaluate the anti-cancer effects of our dismutase mimetics in combination of SBRT in patients. We look forward to reporting topline data from this trial in the second half of 2020.”

Additional information on the trial can be found on clinicaltrials.gov using the identifier NCT03340974.

About GC4419 (Avasopasem Manganese)

Galera’s lead product candidate, avasopasem manganese, is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic that is initially being developed for the reduction of radiation-induced severe oral mucositis (SOM) which is not yet approved. Avasopasem is designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy.