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Development of BIO 300 as a MCM for lethal radiation pneumonitis/fibrosis

开发 BIO 300 作为致命放射性肺炎/纤维化的 MCM

基本信息

批准号：
9201938
负责人：
Isabel Lauren Jackson
金额：
$ 29.9万
依托单位：
HUMANETICS CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-07-01 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9201938
关键词：
Acute Address Adult Respiratory Distress Syndrome Advanced Development Animal Model Animals Anti-Inflammatory Agents Anti-inflammatory Antioxidants Area Under Curve Baltimore Biological Availability Blood Body Weight Bone Marrow C57L/J Mouse Caliber Cell Cycle Cell Cycle Progression Cells Characteristics Chest Chronic DNA Damage Data Development Development Plans Dose Drug Kinetics Evaluation Exposure to FDA approved Face Fibrosis Filgrastim Formulation Free Radicals Future Genistein Goals Granulocyte Colony-Stimulating Factor Hematopoietic Histopathology Human Individual Inflammatory Injury Legal patent Lethal Dose 50 Licensure Life Link Lung Maryland Mediating Medical Modeling Morbidity - disease rate Mus Nuclear Accidents Oral Oral Administration Organ Organ failure Particle Size Pegfilgrastim Pharmaceutical Preparations Play Positioning Attribute Prevention Property Protein Tyrosine Kinase Pulmonary Fibrosis Pulmonary Inflammation Radiation Radiation Injuries Radiation Pneumonitis Radioprotection Rattus Reaction Recombinants Recording of previous events Regimen Rodent Model Role Safety Self-Administered Signal Pathway Signal Transduction Pathway Structure of parenchyma of lung Supervision Supportive care Suspension substance Suspensions Syndrome Terrorism Therapeutic Time Tissues Toxicokinetics Translating Tyrosine Kinase Inhibitor Universities Weight Whole-Body Irradiation Work animal efficacy animal rule cancer radiation therapy course development cytokine therapy drug development effective therapy efficacy testing efficacy trial experience gastrointestinal gender difference improved interest irradiation knowledge base liquid formulation lung injury medical schools mortality nanoparticle oxidative damage preclinical study prevent pulmonary function radiation effect repaired research and development respiratory response

项目摘要

Project Summary A significant need exists for effective medical countermeasures for radiation-induced pneumonitis and pulmonary fibrosis associated with the delayed effects of acute radiation exposure. Of great importance are countermeasures that can be distributed for use without medical supervision, making orally effective countermeasures of high interest and importance. To address this unmet need, Humanetics Corporation is developing BIO 300 Oral Suspension (active ingredient genistein) to treat the delayed effects of acute radiation exposure (DEARE) in the lung. Genistein, a non-specific tyrosine kinase inhibitor, has a strong history of safety, and has substantial radioprotective effects linked to its strong antioxidant capacity, anti-inflammatory properties, and its effects on cell cycle division. In preclinical studies summarized in this proposal BIO 300 has been shown to significantly improve survival, mitigate lung tissue injury, and improve pulmonary function following whole thoracic lung irradiation. The aim of this proposal is to determine the optimum therapeutic dosing regimen of BIO 300 to reduce lung damage and maximize the likelihood for survival following acute radiation exposure to the thoracic region. Models in which the dose response and timecourse of radiation induced pulmonary damage are well defined will be used in the proposed studies. Studies are also proposed to further understand the effect that total or partial body irradiation has on BIO 300’s pharmacokinetic properties. The overall goal of the proposed studies is to advance the development of BIO 300 as a medical countermeasure towards FDA approval. The proposed work builds on the R&D experience of Humanetics Corporation toward the development of BIO 300 as a medical countermeasure for acute radiation exposure. The main emphasis of future development will be to move BIO 300 development into large animal efficacy testing to determine if the positive efficacy data observed in the rodent model translates to a larger animal. Continued development of BIO 300 will undoubtedly expand the scientific knowledge base and support the continued evaluation and development of agents to prevent and/or treat the acute and chronic effects of radiation exposure. Moreover, with BIO 300’s advanced development as a medical radiation countermeasure, and as an adjunct to cancer radiotherapy, it presents an opportunity for an accelerated development course through pivotal efficacy trials and to licensure.

项目总结