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:
- 金额:$ 29.9万
- 依托单位:
- 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:
- 关键词:AcuteAddressAdult Respiratory Distress SyndromeAdvanced DevelopmentAnimal ModelAnimalsAnti-Inflammatory AgentsAnti-inflammatoryAntioxidantsArea Under CurveBaltimoreBiological AvailabilityBloodBody WeightBone MarrowC57L/J MouseCaliberCell CycleCell Cycle ProgressionCellsCharacteristicsChestChronicDNA DamageDataDevelopmentDevelopment PlansDoseDrug KineticsEvaluationExposure toFDA approvedFaceFibrosisFilgrastimFormulationFree RadicalsFutureGenisteinGoalsGranulocyte Colony-Stimulating FactorHematopoieticHistopathologyHumanIndividualInflammatoryInjuryLegal patentLethal Dose 50LicensureLifeLinkLungMarylandMediatingMedicalModelingMorbidity - disease rateMusNuclear AccidentsOralOral AdministrationOrganOrgan failureParticle SizePegfilgrastimPharmaceutical PreparationsPlayPositioning AttributePreventionPropertyProtein Tyrosine KinasePulmonary FibrosisPulmonary InflammationRadiationRadiation InjuriesRadiation PneumonitisRadioprotectionRattusReactionRecombinantsRecording of previous eventsRegimenRodent ModelRoleSafetySelf-AdministeredSignal PathwaySignal Transduction PathwayStructure of parenchyma of lungSupervisionSupportive careSuspension substanceSuspensionsSyndromeTerrorismTherapeuticTimeTissuesToxicokineticsTranslatingTyrosine Kinase InhibitorUniversitiesWeightWhole-Body IrradiationWorkanimal efficacyanimal rulecancer radiation therapycourse developmentcytokine therapydrug developmenteffective therapyefficacy testingefficacy trialexperiencegastrointestinalgender differenceimprovedinterestirradiationknowledge baseliquid formulationlung injurymedical schoolsmortalitynanoparticleoxidative damagepreclinical studypreventpulmonary functionradiation effectrepairedresearch and developmentrespiratoryresponse
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.
项目摘要
迫切需要有效的医学对策来治疗放射性肺炎和
与急性辐射暴露的延迟效应相关的肺纤维化。伟大的
重要的是可以在没有医疗监督的情况下分发使用的对策,使
口服力强的对策具有较高的趣味性和重要性。为了解决这一未得到满足的需求,
人文公司正在开发BIO 300口服混悬剂(活性成分染料木素)以治疗
急性辐射暴露(DEARE)在肺部的延迟效应。金雀异黄素,一种非特异性酪氨酸
激酶抑制剂,有很强的安全性历史,并具有实质性的辐射防护作用,与其相关
具有较强的抗氧化能力、抗炎性能及其对细胞周期分裂的影响。在……里面
在这项提案中总结的临床前研究表明,bio300已经显著改善了
全胸肺移植后存活、减轻肺组织损伤和改善肺功能
辐射。这项建议的目的是确定BIO 300的最佳治疗剂量方案。
减少急性辐射对肺的损伤并最大限度地提高存活的可能性
胸部。放射性肺损伤的剂量反应和时间过程模型
损害的定义很好,将在拟议的研究中使用。还建议进行研究,以进一步
了解全身或局部照射对BIO300‘S药代动力学特性的影响。
拟议研究的总体目标是推动BIO 300作为一种医疗手段的发展
FDA批准的对策。拟议的工作建立在以下研发经验的基础上
人文公司将BIO 300作为急性呼吸道感染的医学对策
辐射暴露。未来发展的重点将是推动BION300的发展
进入大型动物药效试验,以确定在啮齿动物模型中观察到的阳性药效数据
转化为更大的动物。BIO300的持续发展无疑将扩大科学
知识库,并支持持续评价和开发代理,以预防和/或
治疗辐射暴露的急性和慢性影响。此外,随着BIO300的领先,S
作为一种医学放射对策,以及作为癌症放射治疗的辅助手段,它的发展
提供了通过关键的疗效试验加速开发过程的机会,并
执照。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Isabel Lauren Jackson其他文献
Isabel Lauren Jackson的其他文献
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{{ truncateString('Isabel Lauren Jackson', 18)}}的其他基金
Development of BIO 300 for mitigation and/or treatment of radiation pneumonitis and fibrosis
开发用于缓解和/或治疗放射性肺炎和纤维化的 BIO 300
- 批准号:
10401463 - 财政年份:2020
- 资助金额:
$ 29.9万 - 项目类别:
Development of BIO 300 for mitigation and/or treatment of radiation pneumonitis and fibrosis
开发用于缓解和/或治疗放射性肺炎和纤维化的 BIO 300
- 批准号:
10845829 - 财政年份:2020
- 资助金额:
$ 29.9万 - 项目类别:
Development of BIO 300 for mitigation and/or treatment of radiation pneumonitis and fibrosis
开发用于缓解和/或治疗放射性肺炎和纤维化的 BIO 300
- 批准号:
10194370 - 财政年份:2020
- 资助金额:
$ 29.9万 - 项目类别:
Animal Efficacy and Pharmacometric Modeling Core
动物功效和药理学建模核心
- 批准号:
10845825 - 财政年份:2020
- 资助金额:
$ 29.9万 - 项目类别:
Animal Efficacy and Pharmacometric Modeling Core
动物功效和药理学建模核心
- 批准号:
10401458 - 财政年份:2020
- 资助金额:
$ 29.9万 - 项目类别:
Intercollaborative Radiation Countermeasure (INTERACT) Consortium for Advanced Development of Medical Countermeasures to Mitigate/Treat Acute and Delayed Radiation Syndromes
相互协作辐射对策 (INTERACT) 联盟,促进减轻/治疗急性和迟发性辐射综合症的医疗对策高级发展
- 批准号:
10194363 - 财政年份:2020
- 资助金额:
$ 29.9万 - 项目类别:
Animal Efficacy and Pharmacometric Modeling Core
动物功效和药理学建模核心
- 批准号:
10194366 - 财政年份:2020
- 资助金额:
$ 29.9万 - 项目类别:
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