Rapidly boosting innate immunity in the lungs to protect against pneumonia

快速增强肺部的先天免疫力以预防肺炎

基本信息

批准号：
8604670
负责人：
Brenton Scott
金额：
$ 30.81万
依托单位：
PULMOTECT, INC
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-02-01 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8604670
关键词：
Acute leukemia Address Agonist Animal Model Animals Award Bacteria Biological Warfare Breathing Budgets Cancer Patient Canis familiaris Capital Cause of Death Chemicals Clinic Clinical Clinical Research Clinical Trials Communicable Diseases Complication Data Defense Mechanisms Developed Countries Development Disease Ensure Expenditure Funding Funding Mechanisms Future Host resistance Human Immune system Immunity Immunocompromised Host In Vitro Infection Infection prevention Institutional Review Boards Invaded Lead Ligands Lung Manufacturer Name Marketing Microbe Motivation Natural Immunity Organism Outcome Patients Pharmaceutical Preparations Phase Phase I Clinical Trials Phase II Clinical Trials Physicians Pneumonia Positioning Attribute Preparation Process Rattus Risk Safety Secure Small Business Innovation Research Grant Solutions Technology Therapeutic Time Toll-like receptors Transplantation Virus cancer therapy commercialization design fungus in vivo leukemia man novel novel therapeutics pandemic disease pathogen pathogen exposure patient population pre-clinical prevent product development protocol development public health relevance research study treatment planning

项目摘要

DESCRIPTION (provided by applicant): Pneumonia can be caused by a variety of pathogenic organisms including bacteria, fungi and viruses and is the leading cause of death worldwide. Even in developed countries, pneumonia continues to be the leading cause of death from infection and a serious complication for patients being treated for other diseases. The threat of lung infections is elevated when there is a decreased level of host resistance (e.g. immunocompromised cancer patients) and when there is an increased level of pathogen exposure (e.g. pandemics, bioterror, and biowarfare). Acute leukemia patients are currently some of the most at-risk patients, as they are faced with significant immunocompromise resulting from their cancer treatments. Many times infectious complications prevent the full cancer treatment plan from being completed. As a result, each year an estimated 44,700 leukemia patients spend more than one-half billion dollars on a range of treatments in an effort to prevent pneumonia. Despite this expenditure, pneumonia continues to occur in 15-20% of acute leukemia patients. Pulmotect's Solution: Pulmotect has identified and is developing a novel, proprietary technology to address the risks of inhaled microbes. Our therapeutic (PUL-042) is a combination of two Toll-like receptor (TLR) agonist ligands that stimulate the lung's own innate defense mechanisms to create a broad protection against invading pathogens thereby reducing and preventing infection. Supported in part by a successful Phase I SBIR, both in vitro and in vivo preclinical proof-of-concept experiments have been completed to validate this technology and further advance it to the clinic. It is in the most at-risk cancer patients where clinical proof-of- concept can be captured and support development for additional patient populations (transplant, ICU, bioterror, pandemic). The focus of this proposal is to accomplish key milestones that will advance this technology further towards commercialization and bridge to funding already secured for Phase I and Phase II clinical trials. The project is organized into four Specific Aims that address the needed data, drug manufacturing, and approvals to bridge this technology to the clinic.

描述（由申请人提供）：肺炎可由多种病原生物引起，包括细菌、真菌和病毒，是全世界死亡的主要原因。即使在发达国家，肺炎仍然是感染死亡的主要原因，也是接受其他疾病治疗的患者的严重并发症。当宿主抵抗力水平降低（例如免疫功能低下的癌症患者）以及病原体暴露水平增加（例如流行病、生物恐怖和生物战）时，肺部感染的威胁就会增加。急性白血病患者目前是高危患者之一，因为他们面临着因癌症治疗而导致的严重免疫功能低下。很多时候，感染性并发症会阻碍完整的癌症治疗计划的完成。因此，每年估计有 44,700 名白血病患者花费超过 5 亿美元用于预防肺炎的一系列治疗。尽管如此，仍有 15-20% 的急性白血病患者出现肺炎。 Pulmotect 的解决方案：Pulmotect 已经确定并正在开发一种新颖的专有技术来解决吸入微生物的风险。我们的治疗药物 (PUL-042) 是两种 Toll 样受体 (TLR) 激动剂配体的组合，可刺激肺部自身的先天防御机制，从而对入侵的病原体产生广泛的保护，从而减少和预防感染。在 I 期 SBIR 成功的部分支持下，体外和体内临床前概念验证实验均已完成，以验证该技术并进一步将其推向临床。在高危癌症患者中，可以捕获临床概念验证并支持针对其他患者群体（移植、ICU、生物恐怖、流行病）的开发。该提案的重点是实现关键里程碑，进一步推动该技术商业化，并为已经获得的第一期和第二期临床试验提供资金。该项目分为四个具体目标，解决所需的数据、药物制造和批准，以将该技术与临床联系起来。