Ototoxicity protection with intratympanic steroid implant

鼓室内类固醇植入物的耳毒性保护

基本信息

  • 批准号:
    8395587
  • 负责人:
  • 金额:
    $ 15.45万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2012
  • 资助国家:
    美国
  • 起止时间:
    2012-07-12 至 2014-08-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Chemotherapy-induced ototoxicity is damage to the inner ear that is caused by the side effects of administered drugs. This can lead to permanent hearing loss and/or tinnitus (continuous ringing in the ear) in the patient. Some of the most common kinds of drugs causing ototoxicity are antibiotics and anti-cancer therapeutics such as cisplatin. Cisplatin is commonly used for the treatment of a variety of cancers, including medulloblastoma, neuroblastoma, osteosarcoma, and testicular, ovarian, cervical, bladder, lung, and head and neck cancers and is considered one of the most ototoxic drugs in use. The development of an otoprotective treatment to combat chemotherapy-induced hearing loss would have a significant impact on patient quality of life. This is particularly important when treating children as they are more susceptible to drug induced permanent hearing loss. This Phase I SBIR proposal involves the fabrication of steroid based therapeutic treatments for protection against chemotherapy induced ototoxicity. The specific aims of this proposal present a roadmap towards the early stage development of steroid formulations for intratympanic implantation. The specific aims of this proposal are threefold: First, the initial composition of the therapeutic formulation will be developed to incorporate the desired therapeutic dose. Second, the developed therapeutic formulation will be characterized utilizing in vitro analyses. These studies will produce a lead formulation with known therapeutic dose and predicted dosing duration in vivo. Third, the therapeutic formulation will be characterized using appropriate animal models in order to determine the drug release and efficacy in vivo. 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 3 years from a single implantation. Phase II of this project will involve completion of a final formulation for a scale up in manufactue in GMP conditions, the testing of stability and sterility of these formulations, and GLP pharmacokinetic animal studies in two species sufficient to lead to an Investigational New Drug Exemption. The completion of this work will ultimately facilitate a collaboration with a corporate partner for the licensing of our developed product. PUBLIC HEALTH RELEVANCE: Chemotherapy induced ototoxicity is damage to the inner ear which leads to significant debilitating side effects, such as permanent hearing loss and/or tinnitus (continuous ringing in the ear) in the patient. Some of the most common kinds of drugs causing ototoxicity are antibiotics and anti-cancer therapeutics such as cisplatin, and the damage to hearing is most severe in pediatric patients. This Phase I SBIR proposal involves the development of steroid based therapeutic treatments for protection against chemotherapy induced ototoxicity.
描述(申请人提供):化疗引起的耳毒性是指药物的副作用对内耳造成的损害。这可能会导致患者永久性听力损失和/或耳鸣(耳鸣)。导致耳毒性的一些最常见的药物是抗生素和抗癌疗法,如顺铂。顺铂通常用于治疗各种癌症,包括髓母细胞瘤、神经母细胞瘤、骨肉瘤以及睾丸癌、卵巢癌、宫颈癌、膀胱癌、肺癌和头颈癌,被认为是耳毒性最强的药物之一。开发一种耳保护疗法来对抗化疗所致的听力损失将对患者的生活质量产生重大影响。这在治疗儿童时尤其重要,因为他们更容易受到药物引起的永久性听力损失的影响。这项第一阶段的SBIR建议涉及制造以类固醇为基础的治疗方法,以防止化疗引起的耳毒性。这项建议的具体目标为鼓室内植入类固醇制剂的早期开发提供了路线图。这项建议的具体目标有三个:首先,将制定治疗配方的初始组成,以纳入所需的治疗剂量。其次,开发的治疗配方将利用体外分析进行表征。这些研究将产生一种具有已知治疗剂量和体内预测剂量持续时间的铅配方。第三,治疗配方将使用适当的动物模型进行表征,以确定药物在体内的释放和疗效。O-Ray的研究团队是唯一有资格执行本文提出的工作的人,他们在耳科、药物开发和药物输送方面拥有成功开发该产品的专业知识。O-Ray科学家已经成功地开发出目前正在临床上使用的治疗配方。这包括一种眼内缓释类固醇植入物,能够从一次植入后维持抗炎玻璃体内药物水平长达3年。该项目的第二阶段将包括在GMP条件下完成扩大生产的最终配方,这些配方的稳定性和无菌测试,以及足以导致调查性新药豁免的两个物种的GLP药代动力学动物研究。这项工作的完成将最终促进与企业合作伙伴的合作,以获得我们开发的产品的许可。 与公共卫生相关:化疗引起的耳毒性是对内耳的损害,导致显著的衰弱副作用,如永久性听力损失和/或患者的耳鸣(耳鸣)。导致耳毒性的一些最常见的药物是抗生素和抗癌疗法,如顺铂,对听力的损害在儿科患者中最为严重。这项第一阶段的SBIR建议涉及开发以类固醇为基础的治疗方法,以防止化疗引起的耳毒性。

项目成果

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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:
    $ 15.45万
  • 项目类别:
Prevention of Children's Tympanostomy Tube Otorrhea
儿童鼓膜置管性耳漏的预防
  • 批准号:
    9202195
  • 财政年份:
    2014
  • 资助金额:
    $ 15.45万
  • 项目类别:
Sustained Release Inner Ear Delivery of Corticosteroid
皮质类固醇的持续释放内耳递送
  • 批准号:
    8776660
  • 财政年份:
    2007
  • 资助金额:
    $ 15.45万
  • 项目类别:

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