-- Evaluates avasopasem manganese’s ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer --
-- Marks expansion of lead product candidate avasopasem manganese into second radiation toxicity indication --
The open-label, multi-center trial will evaluate the efficacy of avasopasem manganese, a highly selective small molecule superoxide dismutase (SOD) mimetic, in reducing the incidence of severe (Grade 2 or worse on the NCI Common Terminology Criteria for Adverse Events scale) acute radiation-induced esophagitis in patients with lung cancer receiving chemoradiotherapy. Approximately 60 adult patients with pathologically confirmed unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers will be enrolled at approximately 10 sites. Patients in the trial will receive 90 mg of avasopasem manganese by infusion on the days they receive their radiation therapy.
“Radiation-induced esophagitis is a common, debilitating side effect that can delay or prevent curative cancer treatment, and no FDA-approved therapies to treat it currently exist,” said
There are approximately 230,000 new lung cancer patients diagnosed annually in
“We’re pleased to expand the evaluation of avasopasem manganese into a second radiation toxicity, esophagitis, in patients with lung cancer,” said
About Avasopasem Manganese (GC4419)
Galera’s lead product candidate, avasopasem manganese (GC4419), is a highly selective small molecule superoxide dismutase (SOD) mimetic that is initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem manganese 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.
GC4419 is currently being studied in the ROMAN trial, a randomized, double blind, placebo-controlled Phase 3 trial with 365 patients (NCT03689712 available at clinicaltrials.gov) to determine the efficacy and safety of avasopasem manganese in patients with locally advanced head and neck cancer and radiation-induced OM. In Galera’s 223-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial in patients with locally advanced head and neck cancer receiving concurrent radiation therapy, avasopasem manganese significantly reduced the duration of SOM by 92 percent (from 19 days to 1.5 days in the 90 mg treatment arm). The incidence of SOM and the incidence of Grade 4 OM were also significantly reduced (by 34 percent and 47 percent, respectively, in the 90 mg treatment arm) in patients treated with avasopasem manganese. No significant safety signals were observed demonstrating avasopasem manganese is well tolerated when added to a standard radiotherapy regimen. The two-year tumor outcomes follow up of patients enrolled in the trial were consistent with expectations for intensity-modulated radiation therapy (IMRT)/cisplatin alone suggesting that radiation efficacy was maintained.
Avasopasem manganese is also currently being studied in a Phase 2a trial for its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer, as well as in a pilot Phase 1/2 trial (NCT03340974 available at clinicaltrials.gov) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer.
The
About
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 expectations surrounding the potential, efficacy, and regulatory and clinical development of Galera’s product candidates, including the Phase 2a clinical trial of avasopasem manganese to reduce the incidence of radiation-induced esophagitis in patients with lung cancer. 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; uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA’s acceptance of data from clinical trials outside
Investor Contacts:
610-725-1500
cdegnan@galeratx.com
Solebury Trout
617-221-9197
crusso@soleburytrout.com
Media Contact:
6 Degrees
980-938-0260
handerson@6degreespr.com
2020 GlobeNewswire, Inc., source