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

• 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
• 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

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）：估计全球有3亿人受哮喘影响，每年导致多达250，000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，其中近10%的人口失去了大量的工作和学习时间。病毒性呼吸道感染是哮喘急性发作的主要原因，占70%以上3。Pulmotect正在开发一种预防呼吸道感染的新技术。先导药物（PUL-042）是两种TLR配体的组合，刺激肺部自身的先天防御机制，为病原体创造一个敌对的环境，可以预防或减轻呼吸道感染。该技术已通过体外和体内实验进行了验证，该药物已在监管过程中取得进展，作为一种治疗方法，使癌症患者在免疫功能低下期间受益。在目前的提案中，我们提出了实现里程碑的计划，这些里程碑将通过以下方式推动这项技术在哮喘市场的商业化：1）显示PUL-042在小鼠哮喘模型中的直接益处; 2）开展关键开发活动，以支持哮喘患者的临床试验。该项目被组织成六个可衡量的具体目标在建议书中描述。