Scientific Publications
One-year Reductions in Cisplatin Related Chronic Kidney Disease (CKD) in Patients With Head and Neck (HNC) Cancer Treated With Avasopasem Manganese: A Prespecified Analysis From the Phase 3 ROMAN Trial.
Presented at ASCO Annual Meeting, June 5, 2023.
Avasopasem manganese (GC4419) protects against cisplatin-induced chronic kidney disease: An exploratory analysis of renal metrics from a randomized phase 2b clinical trial in head and neck cancer patients.
Redox Biology. 2023; 60:102599.
Net treatment benefit of avasopasem manganese for severe oral mucositis from the ROMAN trial.
Presented at European Congress on Head & Neck Oncology, March 10, 2023.
Tumor outcomes for ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced head and neck cancer (LAHNC).
Presented at ASTRO Annual Meeting, October 26, 2022.
Two-year tumor outcomes of Phase 2B, randomized, double-blind trial of avasopasem manganese (GC4419) versus placebo to reduce severe oral mucositis due to concurrent radiation therapy and cisplatin for head and neck cancer.
Int J Radiation Oncol Biol Phys. 2022; 114:416-421.
ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC).
Presented at ASCO Annual Meeting, June 3, 2022.
ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC).
J Clin Oncol. (suppl16):Abstract 6005.
Avasopasem manganese synergizes with hypofractionated radiation to ablate tumors through the generation of hydrogen peroxide.
Sci Transl Med. 2021; 13:eabb3768.
Randomized, double-blinded, placebo-controlled multicenter adaptive phase 1-2 trial of GC4419, a dismutase mimetic, in combination with high dose stereotactic body radiation therapy (SBRT) in locally advanced pancreatic cancer (PC).
Presented at: ASTRO Annual Meeting, October 25-28, 2020.
Phase IIb, randomized, double-blind trial of GC4419 versus placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer.
J Clin Oncol. 2019; 37:3256-3265.
Phase 1b/2 trial of the superoxide dismutase mimetic GC4419 to reduce chemoradiotherapy-induced oral mucositis in patients with oral cavity or oropharyngeal carcinoma.
Int J Radiation Oncol Biol Phys. 2018; 100:427-435.