Initial results from pilot Phase 1/2 clinical trial in patients with locally advanced pancreatic cancer presented during virtual ASTRO Annual Meeting
First trial to evaluate anti-cancer activity of one of Galera’s dismutase mimetics in combination with SBRT
Management will host a live audio webcast at 4:30 p.m. EDT
GC4419 is an investigational, highly selective small molecule superoxide dismutase mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen. The randomized, double-blind, multicenter, placebo-controlled pilot dose escalation Phase 1/2 trial was designed to evaluate the safety and efficacy of GC4419 in combination with SBRT, compared with SBRT and placebo, in patients with LAPC. The trial assessed safety and efficacy of SBRT when combined with GC4419 or placebo. After completion of induction chemotherapy, patients were randomized (1:1) to receive five-fraction SBRT and 90 mg of GC4419 or placebo control by intravenous infusion one hour prior to each SBRT fraction.
In the interim analysis of the intent-to-treat population (n=42), median overall survival (OS) had not been reached at the data cutoff (date of
“The survival rate in pancreatic cancer is dismal. Our goals for treatment are to extend survival and improve the potential for surgical resection, as surgery remains the only potentially curative therapy for pancreatic cancer,” said
The interim data includes all patients followed for a minimum of three months and 19 for more than one year, with data through
“We’re encouraged by the favorable overall survival benefit in this difficult-to-treat cancer observed in the interim data in this trial, which is the first trial evaluating the anti-cancer activity of one of Galera’s dismutase mimetics in combination with SBRT,” said
The Company plans to leverage observations from this pilot trial to further develop GC4711, its second superoxide dismutase mimetic clinical candidate, specifically for use in combination with SBRT, and anticipates initiating a follow-on Phase 2 trial in pancreatic cancer with GC4711 in combination with SBRT in the first half of 2021. Galera recently announced it is also evaluating the anti-cancer activity of GC4711 in an ongoing Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NSCLC).
The presentation is available for on-demand viewing for registered ASTRO attendees for the next 30 days.
Conference Call
Galera will host a live audio webcast at 4:30 p.m. EDT today accessible from the Investors page of Galera’s website, investors.galeratx.com. An archived version of the webcast will be available in the News & Events section of the Investors page of Galera’s website for 60 days following the event.
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.
Avasopasem is currently being studied in the ROMAN trial, a randomized, double-blind, placebo-controlled Phase 3 trial of approximately 450 patients (NCT03689712, available at clinicaltrials.gov) to investigate the effects of avasopasem on radiation-induced OM in patients with locally advanced head and neck cancer. In Galera’s 223-patient, double-blind, randomized, placebo-controlled Phase 2b trial in patients with locally advanced head and neck cancer receiving concurrent radiation therapy, avasopasem produced a statistically significant reduction in duration of SOM from 19 days to 1.5 days (92 percent) in the 90 mg treatment arm. Avasopasem also demonstrated clinically meaningful reductions in SOM incidence through completion of radiation by 34 percent and in the severity of OM (incidence of Grade 4 OM) by 47 percent in the 90 mg treatment arm. The overall safety findings for avasopasem in the Phase 2b trial was similar to that of placebo and consistent with the known adverse effects of chemoradiation, with reductions of blood cell counts, particularly low lymphocyte counts, the most prominent adverse events. Adverse events considered attributable to avasopasem were limited to mild, transient postural light-headedness or decreased blood pressure. Patients were followed for two years after enrollment and showed no difference in tumor outcomes between active and control, consistent with expectations for combinations with intensity-modulated radiation therapy (IMRT)/cisplatin, suggesting that the efficacy of the chemoradiation therapy was not compromised.
Avasopasem is also currently being studied in a Phase 2a trial for its potential to reduce the incidence of radiation-induced esophagitis in patients with lung cancer (NCT04225026, available at clinicaltrials.gov) and in a Phase 2 trial in hospitalized patients who are critically ill with COVID-19 (NCT04555096, available at clinicaltrials.gov); and a pilot Phase 1/2 trial (NCT03340974, available at clinicaltrials.gov) of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer was completed.
The U.S. Food and Drug Administration granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical development of Galera’s product candidates, including with respect to the pilot Phase 1/2 clinical trial of GC4419 in combination with SBRT for LAPC and related data readouts, as well as the development of GC4711; and Galera’s participation in upcoming events and presentations. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera’s limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera’s dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; results of earlier studies and trials may not be predictive of future trial results; interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; the FDA’s acceptance of data from clinical trials outside
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