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）：该阶段项目继续成功地发现了新型装饰剂，这些新型装饰剂对放射性锶（SR）有选择性。该项目包括提交紧急使用授权（EUA）或调查新药（IND）申请的必要步骤。一个目标是在年底之前，为FDA申请提供口头管理的Gi-Chelation配方，以供战略国家库存（SNS）。该项目以“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合并是很高的DHHS / NIH / NIAID / DAIT优先级，而SR-90暴露的治疗仍然是SNS的关键需求。 SR-90及其女儿YTTrium-90是将其能量沉积在体内的Beta发射器。 SR-90很容易被呼吸道和GI路线吸收，多达50％的剂量将沉积在骨骼中。当前的胃肠道吸收阻断剂（例如磷酸铝）的有效性低，尽管建议用于临床使用。没有SR特异性装饰剂可用。