THE PHARMACOLOGICAL DEVELOPMENT OF IPW-5371 FUMARATE AS A RADIATION MEDICAL COUNTERMEASURE FOR THE TREATMENT OF DELAYED RADIATION LUNG INJURY UNDER THE FDA ANIMAL RULE

IPW-5371 富马酸盐作为放射医学对策的药理学开发，用于治疗 FDA 动物规则下的迟发性辐射肺损伤

• 批准号: 10932585
• 负责人: BARRY HART
• 金额: $ 149.99万
• 依托单位: INNOVATION PATHWAYS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10932585
• 关键词: Acute; Animal Model; Animals; Biological Markers; Characteristics; Critical Pathways; Development; Evaluation; Fumarates; Histologic; Lung; Organ; Pathway interactions; Preparation; Radiation; Radiation exposure; Radiation induced damage; Toxicology; Transforming Growth Factor beta; animal rule; innovation; irradiation; kinase inhibitor; medical countermeasure; multiorgan injury; pharmacokinetics and pharmacodynamics; pharmacologic; radiation-induced lung injury; radiological imaging; receptor; small molecule

This proposal, using partial body irradiation (PBI) animal models to study the delayed effects of acute radiation exposure (DEARE) on survival due to multi-organ injury, including the lungs. The proposal is focused on supporting the critical path for FDA approval of an Innovation Pathways, small molecule TGFβ Receptor-1 kinase inhibitor MCM. Under the guidance criteria of the FDA “Animal Rule” (AR).

该提案使用部分身体照射（PBI）动物模型来研究急性辐射暴露（DEARE）对多器官损伤（包括肺部）造成的生存的延迟影响。该提案的重点是支持 FDA 批准该药物的关键路径。创新途径，小分子 TGFβ 受体-1 激酶抑制剂 MCM，符合 FDA“动物规则”(AR) 的指导标准。