Sustained Release Inner Ear Delivery of Corticosteroid
皮质类固醇的持续释放内耳递送
基本信息
- 批准号:8776660
- 负责人:
- 金额:$ 83.91万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2007
- 资助国家:美国
- 起止时间:2007-06-10 至 2016-05-31
- 项目状态:已结题
- 来源:
- 关键词:Adrenal Cortex HormonesAnimal ModelAnimalsAnti-Inflammatory AgentsAnti-inflammatoryBiological AssayBiological PreservationCaviaChemicalsChemistryClinicClinical TrialsCochlear ImplantsComplete Hearing LossDevelopmentDevicesDoseDrug Delivery SystemsDrug FormulationsDrug StabilityElectric StimulationElectrodesEnsureFeedbackFrightFutureGoalsHair CellsHearingHistologyHumanImplantImplanted ElectrodesInflammationLabyrinthLicensingMechanicsMediationOperative Surgical ProceduresOtologyPatientsPellet Drug FormPharmaceutical PreparationsPhasePlasmaPolymersPolyvinyl AlcoholProceduresProcessPropertyQualifyingResearch PersonnelResidual stateSafetyScientistSmall Business Innovation Research GrantSterilizationSteroidsTechnologyTestingTherapeuticTimeTissuesTraumaValidationWorkbasechemical propertydrug developmentelectric impedancefluticasonehearing impairmentimplant materialimplantationin vitro Assayin vitro testingphysical propertypre-clinicalproduct developmentprotective effectprototypepublic health relevancesafety studysafety testingstability testing
项目摘要
DESCRIPTION (provided by applicant): Cochlear implants have restored hearing in thousands of patients over the last two decades. However, because residual hearing is damaged in the process of insertion, this valuable procedure has been restricted to those patients with profound or total deafness. Many patients with severe hearing loss, a far larger group, are not currently implanted for fear of losing their residual hearing. Steroids have been shown to have a protective effect against hearing loss caused by cochlear trauma. O-Ray's drug delivery technology releases steroids directly from a cochlear implant electrode, decreasing surgery associated inflammation and, in turn, protecting against residual hearing loss. The successful development of O-Ray's cochlear implant for the preservation of residual hearing would have a dramatic impact on hundreds of thousands of patients each year that would now be able to restore hearing using this device. O-Ray's team has demonstrated the safety and efficacy of its steroid releasing cochlear implants in animal models and has produced a prototype device. This Phase IIB proposal is founded on feedback from the FDA and involves the completion of all steps necessary for regulatory approval for the initiation of clinical trials The Specific Aims of this proposal are threefold: First, the Good Manufacturing Practice (GMP) manufacture of O- Ray's cochlear implant electrode with steroid for clinical trials. Second, the characterization of the manufactured steroid eluting electrodes. This will include in vitro tests t assay the physical and chemical properties of the electrode, as well as the stability of the drug in the completed device. Lastly, safety studies of cochlear implant electrode with extended release steroid will be performed to verify the safety of the device for human use. The team of investigators at O-Ray is uniquely qualified to perform the work proposed herein, and has expertise in otology, drug development and drug delivery for the successful development this product. O-Ray scientists have successfully developed therapeutic formulations that are currently being used in the clinic. This includes an intraocular sustained release steroid implant capable of maintaining anti-inflammatory intravitreal drug levels for periods of up to three years from a single implantation. At the completion of this work, an IDE will be filed with the FDA for the approval to commence clinical trials. At this point, O-Ray will sell its product to a large cochlear implant company for commencement of clinical trials and introduction of the product to the marketplace.
描述(由申请人提供):在过去的二十年里,人工耳蜗已经帮助数千名患者恢复了听力。然而,由于残余听力在插入过程中受到损害,因此这种有价值的手术仅限于那些患有严重或完全耳聋的患者。许多患有严重听力损失的患者(这一群体要大得多)目前并未因担心失去残余听力而没有进行植入。类固醇已被证明对耳蜗创伤引起的听力损失具有保护作用。 O-Ray 的药物输送技术直接从人工耳蜗植入电极释放类固醇,减少手术相关的炎症,从而防止残余听力损失。用于保留残余听力的 O-Ray 人工耳蜗的成功开发将对每年数十万患者产生巨大影响,他们现在可以使用该设备恢复听力。 O-Ray 的团队已在动物模型中证明了其类固醇释放人工耳蜗的安全性和有效性,并生产了原型设备。该 IIB 期提案以 FDA 的反馈为基础,涉及完成监管机构批准启动临床试验所需的所有步骤。该提案的具体目标有三个:首先,按照良好生产规范 (GMP) 制造用于临床试验的 O-Ray 类固醇人工耳蜗植入电极。其次,制造的类固醇洗脱电极的表征。这将包括体外测试,以测定电极的物理和化学特性,以及药物在完整设备中的稳定性。最后,将对含有缓释类固醇的人工耳蜗植入电极进行安全性研究,以验证该设备供人类使用的安全性。 O-Ray 的研究人员团队具有执行本文提出的工作的独特资格,并拥有耳科、药物开发和药物输送方面的专业知识,以成功开发该产品。欧射线科学家已成功开发出目前用于临床的治疗配方。其中包括一种眼内缓释类固醇植入物,单次植入后能够在长达三年的时间内维持玻璃体内抗炎药物水平。这项工作完成后,将向 FDA 提交 IDE 以获得批准开始临床试验。此时,O-Ray 将把其产品出售给一家大型人工耳蜗植入公司,以开始临床试验并将该产品推向市场。
项目成果
期刊论文数量(0)
专著数量(0)
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会议论文数量(0)
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ERIK PIERSTORFF其他文献
ERIK PIERSTORFF的其他文献
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{{ truncateString('ERIK PIERSTORFF', 18)}}的其他基金
Intratympanic delivery of biologics for treatment of autoimmune inner ear disease
鼓室内输送生物制剂治疗自身免疫性内耳疾病
- 批准号:
8981176 - 财政年份:2015
- 资助金额:
$ 83.91万 - 项目类别:
Prevention of Children's Tympanostomy Tube Otorrhea
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9202195 - 财政年份:2014
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$ 83.91万 - 项目类别:
Ototoxicity protection with intratympanic steroid implant
鼓室内类固醇植入物的耳毒性保护
- 批准号:
8395587 - 财政年份:2012
- 资助金额:
$ 83.91万 - 项目类别:
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