Development of a novel product for skin decontamination after exposure to chemical warfare agents

开发一种用于接触化学战剂后皮肤净化的新产品

• 批准号: 10263360
• 负责人: Scott Noblitt
• 金额: $ 27.14万
• 依托单位: ARMIS BIOPHARMA, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10263360
• 关键词: Acetic Acids; Adverse effects; Animals; Antibiotics; Cavia; Chemical Warfare; Chemical Warfare Agents; Chemicals; Clinical Pathology; Decontaminant; Decontamination; Department of Defense; Dermal; Development; Dose; Equilibrium; Event; Exposure to; FDA approved; Formulation; Future; Grant; Hand; Histopathology; Human; Incentives; Individual; Lead; Liquid substance; Measures; Medical Research; Methodology; Methods; Miniature Swine; Oxygen; Peracetic Acid; Phase; Pilot Projects; Population; Procedures; Production; Program Development; Rattus; Research Design; Research Institute; Risk; Rodent; Safety; Series; Site; Skin; System; Temperature; Terrorism; Testing; Toxic effect; Toxicokinetics; Water; first responder; in vivo; interest; irritation; mass casualty; nerve agent; novel; pathogen; safety study; service member; systemic toxicity

ABSTRACT With the increasing threat of terrorism, the development of countermeasures for the event of a chemical attack on civilians has become a high priority. Mass casualty events in which chemical warfare agents (CWA) would be employed in an attack on a civilian population, are a concrete risk. Because of significant differences between members of the military and civilians, existing countermeasures may need to be adapted or expanded for use in a civilian population. This project proposes the development of Veriox®, a proprietary formulation, to provide first responders working on mass-casualty decontamination (DC) an inexpensive, FDA approved, fast-acting, field- deployable skin decontamination kit that would provide superior levels of protection when compared to the current field-deployed products. Veriox® offers several advantages over existing DC products for mass casualty settings, because it can be rapidly dispensed with standard liquid dispensing systems (hand operated sprayers and mass casualty shower systems) that will allow first responders to quickly decontaminate multiple individuals. Last but not least, since Veriox® breaks down rapidly into harmless products, it demonstrates a better safety and toxicity profile, and is also environmentally safe. While Veriox® is a potentially broad-spectrum decontaminant, with efficacy shown already against Generating Antibiotic Incentives Now (GAIN) Act pathogens, this project focuses on its development in the context of nerve agent decontamination. We present a strong background of preliminary studies demonstrating efficacy in vivo. The next step of the development program is to demonstrate safety of the product in animals which will then enable advancement of the product into human testing. This is the focus of the present grant.

摘要 随着恐怖主义威胁的日益严重，针对化学袭击事件的对策的发展 对平民的威胁已经成为当务之急大规模伤亡事件中，化学战剂（CWA）将 在攻击平民人口时使用的武器是一种具体的风险。由于存在显著差异， 军事和文职人员，现有的反措施可能需要调整或扩大，以用于 平民人口。该项目建议开发专利配方Veriox®， 大规模伤亡去污（DC）工作的响应者，一种廉价的，FDA批准的，快速反应的，现场， 可展开的皮肤去污套件，当与 目前的现场部署产品。Veriox®与现有的大规模伤亡事故处理DC产品相比具有多项优势 因为它可以用标准的液体分配系统（手动喷雾器）快速分配 和大规模伤亡淋浴系统），这将允许第一响应者快速净化多个人。 最后但并非最不重要的是，由于Veriox®能迅速分解成无害的产品，因此它具有更好的安全性， 毒性特征，并且对环境安全。虽然Veriox®是一种潜在的广谱去污剂， 该项目已经显示出对现在产生抗生素激励（GAIN）法案病原体的有效性， 重点介绍了其在神经毒剂去污方面的发展。我们提供了一个强大的背景， 初步研究证明了体内疗效。开发计划的下一步是展示 产品在动物中的安全性，这将使产品进入人体试验。这是 本补助金的重点。