Preventing asthma exacerbations by reducing viral respiratory infections

通过减少病毒性呼吸道感染来预防哮喘恶化

基本信息

批准号：
8716580
负责人：
Brenton Scott
金额：
$ 98.56万
依托单位：
PULMOTECT, INC
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-01 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8716580
关键词：
Affect Asthma Attenuated Breathing Cancer Patient Capital Cessation of life Characteristics Chemicals Chemistry Clinic Clinical Research Clinical Trials Communicable Diseases Data Defense Mechanisms Developed Countries Development Dose Drug Design Economic Burden Effectiveness Environment Future Human Immune system Immunity Immunocompromised Host In Vitro Institutional Review Boards Investigational New Drug Application Lead Ligands Lung Marketing Measurable Modeling Mus Outcome Patients Pharmaceutical Preparations Phase Phase I Clinical Trials Phenotype Population Positioning Attribute Powder dose form Preparation Process Public Health Qualifying Reference Standards Regimen Resistance Respiratory Tract Infections Safety Schools Small Business Innovation Research Grant Solutions Technology Time Toxic effect Toxicology Viral Virus Virus Diseases Work aerosolized airway hyperresponsiveness analytical method commercialization drug development health economics in vivo meetings new technology novel therapeutics pathogen prevent product development protocol development public health relevance research study respiratory response safety study treatment planning

项目摘要

DESCRIPTION (provided by applicant): An estimated 300 million people worldwide are affected by asthma, causing up to 250,000 deaths per year1,2. Asthma is a personal and public, health and economic burden even in developed countries, where nearly 10% of the population loses substantial time away from work and school. The principal cause of asthma exacerbations, responsible for more than 70%3, is viral respiratory infections. Pulmotect is developing a novel technology to prevent respiratory infections. The lead drug (PUL-042) is a combination of two TLR ligands that stimulates the lungs own innate defense mechanisms, creating a hostile environment for pathogens that can prevent or attenuate respiratory infections. This technology has been validated by both in vitro and in vivo experiments and the drug is already progressing in the regulatory process as a treatment to benefit cancer patients during periods of immunocompromise. In the current proposal, we present plans to accomplish milestones that will advance this technology for commercialization for the asthma market by 1) showing the direct benefit of PUL-042 in mouse asthma models and 2) conducting key development activities to support a clinical trial in patients with asthma. The project is organize into six measurable Specific Aims described in the proposal.

描述（由申请人提供）：估计全世界有 3 亿人受到哮喘的影响，每年导致多达 25 万人死亡1,2。即使在发达国家，哮喘也是一种个人和公共、健康和经济负担，在这些国家，近 10% 的人口失去了大量缺勤和上学的时间。病毒性呼吸道感染是导致哮喘恶化的主要原因（占 70%3 以上）。 Pulmotect 正在开发一种预防呼吸道感染的新技术。主要药物 (PUL-042) 是两种 TLR 配体的组合，可刺激肺部自身的先天防御机制，为病原体创造一个敌对环境，从而预防或减轻呼吸道感染。该技术已通过体外和体内实验的验证，并且该药物已经在监管过程中取得进展，作为一种治疗方法，可以使免疫功能低下期间的癌症患者受益。在当前的提案中，我们提出了实现里程碑的计划，这些里程碑将通过 1) 展示 PUL-042 在小鼠哮喘模型中的直接益处，以及 2) 开展关键开发活动以支持哮喘市场的临床试验，从而推动这项技术在哮喘市场的商业化。哮喘患者。该项目分为提案中描述的六个可衡量的具体目标。