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.

抽象的 随着恐怖主义威胁的日益增加，针对化学袭击事件的对策的制定 平民问题已成为当务之急。化学战剂（CWA）可能导致的大规模伤亡事件 被用于袭击平民是一个具体的风险。由于之间存在显着差异 对于军人和文职人员来说，现有的反措施可能需要进行调整或扩大以用于 平民人口。该项目建议开发 Veriox®（一种专有配方），以提供第一个 致力于大规模伤亡净化 (DC) 的响应人员是一种廉价、经 FDA 批准、快速起效的现场净化设备 可展开的皮肤净化套件，与传统的皮肤净化套件相比，可提供更高水平的保护 当前现场部署的产品。 Veriox® 与现有 DC 产品相比，在大规模伤亡事故方面具有多项优势 设置，因为它可以通过标准液体分配系统（手动喷雾器）快速分配 和大规模伤亡淋浴系统），这将使急救人员能够快速对多人进行消毒。 最后但并非最不重要的一点是，由于 Veriox® 能迅速分解为无害产品，因此它表现出更好的安全性和 毒性概况，并且对环境也是安全的。虽然 Veriox® 是一种潜在的广谱去污剂， 该项目已显示出针对《立即产生抗生素激励法案》(GAIN) 病原体的功效 重点关注其在神经毒剂净化背景下的发展。我们提供强大的背景 初步研究证明了体内功效。开发计划的下一步是展示 产品在动物中的安全性，这将使产品能够进入人体测试。这是 本次赠款的重点。