Selective Decorporation Agents for NIAID

NIAID 选择性装饰剂

• 批准号: 8522252
• 负责人: Benjamin P Warner
• 金额: $ 100万
• 依托单位: ICAGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8522252
• 关键词: 90Y; Affect; Animals; Authorization documentation; Binding; Biological Assay; Biological Markers; Blood Circulation; Calcium; Cell Culture Techniques; Cell membrane; Cells; Chelating Agents; Clinical; Collaborations; Complex; Daughter; Deposition; Development; Development Plans; Dose; Drug Formulations; Drug Kinetics; Effectiveness; Emergency Situation; Excretory function; Goals; Government; Housing; Human; Human body; In Vitro; Industry; Investigational Drugs; Investigational New Drug Application; Ions; Kinetics; Lead; Libraries; Mammals; Metals; Military Personnel; National Institute of Allergy and Infectious Disease; Oral; Penetration; Permeability; Pharmaceutical Preparations; Phase; Plasma; Plasma Proteins; Protein Binding; Protocols documentation; Radioactive; Research Institute; Route; Safety; Serum; Services; Strontium; Strontium-90; Structure-Activity Relationship; Testing; TimeLine; Toxic effect; United States National Institutes of Health; absorption; aluminum phosphate; animal efficacy; bone; chelation; commercialization; drug candidate; efficacy testing; efficacy trial; high throughput screening; high throughput technology; in vivo; instrument; novel; pre-clinical; respiratory

DESCRIPTION (provided by applicant): This Phase II project continues the successful Phase I discovery of novel decorporation agents that are selective for radioactive strontium (Sr). This project consists of the necessary steps for submission of an Emergency Use Authorization (EUA) or Investigational New Drug (IND) application to the US FDA. A goal is to have orally- administered, GI-chelation formulations ready for an FDA application by the end of year for the Strategic National Stockpile (SNS). This project is guided by the "Guidance for Industry: Internal Radioactive Contamination -Development of Decorporation Agents." Sr-90 is easily obtained by terrorists;radioactive Sr-decorporation is a very high DHHS / NIH / NIAID / DAIT priority and treatments for Sr-90 exposure remain a critical need for the SNS. Sr-90 and its daughter yttrium-90 are beta emitters that deposit their energy in the body. Sr-90 is readily absorbed by both respiratory and GI routes and up to 50% of a dose will be deposited in bone. Current GI absorption blocking agents, such as aluminum phosphate, are of low effectiveness, although they are recommended for clinical use. There are no Sr-specific decorporation agents available.

描述（由申请人提供）：该第二阶段项目延续了第一阶段成功发现的对放射性锶（Sr）具有选择性的新型脱色剂。该项目包括向美国 FDA 提交紧急使用授权 (EUA) 或研究性新药 (IND) 申请的必要步骤。我们的目标是在年底前为 FDA 申请国家战略储备 (SNS) 准备好口服胃肠道螯合制剂。本项目以《行业指南：内部放射性污染-装饰剂的开发》为指导。 Sr-90 很容易被恐怖分子获得；放射性 Sr 解体是 DHHS / NIH / NIAID / DAIT 的高度优先事项，Sr-90 暴露的治疗仍然是 SNS 的关键需求。 Sr-90 及其子体 yttrium-90 是 β 发射体，可将能量储存在体内。 Sr-90 很容易通过呼吸道和胃肠道吸收，高达 50% 的剂量会沉积在骨骼中。目前的胃肠道吸收阻断剂，例如磷酸铝，尽管推荐用于临床，但效果较低。没有可用的 Sr 专用脱色剂。