Anderson CM, Salvaggio S, De Backer M, Buyse M, et al. 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.
Anderson CM, Lee C, Kelley JR, et al. 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.
Anderson CM, Lee C, Kelley JR, et al. 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.
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Anderson CM, Lee CM, Saunders DP, et al. 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.
Anderson CM, Lee CM, Saunders D, et al. 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. June 17 2022 [online ahead of print].
Mapuskar KA, Allen BG, et al. 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 (Vol. 60). April 2023 [online ahead of print].
Anderson CM, Sonis ST, Lee CM, et al. 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.
Sishc BJ, Ding L, Nam T-K, et al. Avasopasem manganese synergizes with hypofractionated radiation to ablate tumors through the generation of hydrogen peroxide. Sci Transl Med 2021;13:eabb3768.
Hoffe SE, Frakes J, Aguilera TA, et al. 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
Investigational Drugs – Not for Commercial Distribution
