Aug 9 (Reuters) - Galera Therapeutics Inc (GRTX.O) said the U.S. health regulator declined to approve its drug to treat radiotherapy-induced severe mouth inflammation in patients with advanced head and neck cancer undergoing standard-of-care treatment.
Galera Announces FDA Acceptance and Priority Review of Avasopasem NDA for Radiotherapy-Induced Severe Oral Mucositis
MALVERN, Pa., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel,...
Avasopasem produced clinically meaningful, statistically significant reduction of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer receiving radiotherapy Company on...
The small biotech posted an update Tuesday on the phase 3 trial of avasopasem manganese in severe oral mucositis, or SOM. Oral mucositis is a condition in which the epithelial cells lining the gastrointestinal tract break down following radiotherapy treatment, causing an inability to eat solid food or drink liquids in its most serious form.
Avasopasem manganese (avasopasem) was being tested for reducing SOM in patients with locally advanced head and neck cancer during a late-stage trial called ROMAN, according to a Tuesday statement. Galera was hoping to see a reduction in incidence of the condition, which occurs in about 70% of patients who receive radiation for head and neck cancer.
MALVERN, Pa., June 28, 2021 (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 completion of enrollment in its pivotal Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for the treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. This achievement has triggered a $37.5 million milestone payment from funds managed by Blackstone Life Sciences to Galera under the amended royalty agreement.
MALVERN, Pa., Sept. 16, 2020 (GLOBE NEWSWIRE) --Â Galera Therapeutics, LLC. (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 first patient has been dosed in a pilot Phase 2 clinical trial of lead product candidate avasopasem manganese (GC4419) to evaluate its ability to improve 28-day mortality in hospitalized patients who are critically ill with COVID-19. GC4419 is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen.
MALVERN, Pa., May 13, 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 a retrospective analysis of Phase 2b trial data demonstrating the potential renal protective activity of lead candidate avasopasem manganese (GC4419), and two ongoing clinical trials evaluating avasopasem, will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. Abstracts are available now in the ASCO digital program, and presentations will be available for on-demand viewing on May 29, 2020, at 8 a.m. EDT.
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 three abstracts regarding lead candidate avasopasem manganese (GC4419) were accepted for presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. The titles of the abstracts are currently available in the ASCO digital program, with the full abstracts scheduled to be published on May 13, 2020, at 5 p.m. EDT. Presentations will be available for on-demand viewing on May 29, 2020, at 8 a.m. EDT.