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: 10080358
• 负责人: Scott Noblitt
• 金额: $ 42.3万
• 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/10080358
• 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; Military Personnel; 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; member; nerve agent; novel; pathogen; safety study; 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增加，针对化学袭击事件的对策的制定 对平民的威胁已成为一项高度优先事项。化学战剂(CWA)将发生的大规模伤亡事件 受雇于攻击平民人口，是一个具体的风险。因为两国之间的显著差异 对于军事人员和平民，可能需要调整或扩大现有的反措施，以便在 平民百姓。该项目建议开发专有配方Veriox®，以提供第一个 从事大规模伤亡净化(DC)工作的响应人员是FDA批准的一种廉价、快速、现场- 可部署的皮肤去污套件，与 当前现场部署的产品。与现有DC产品相比，Veriox®可为大规模伤亡提供多项优势 设置，因为它可以快速地与标准液体分配系统(手动喷雾器)一起使用 和大规模伤亡淋浴系统)，这将使急救人员能够快速净化多个人。 最后但并非最不重要的一点是，由于Veriox®迅速分解成无害的产品，它表现出更好的安全性和 毒性分布，也是环境安全的。虽然Veriox®是一种潜在的广谱去污剂， 由于已经显示出对产生抗生素诱因的有效性，现在(获得)法案病原体，这个项目 重点介绍了其在神经毒剂去污方面的发展。我们展示了一个强有力的背景 初步研究证明了体内的有效性。开发计划的下一步是演示 产品在动物身上的安全性，这将使产品能够进入人体测试。这是 这笔赠款的重点。