Sideport Needle Array Technologies for Prioritizing Drugs for Cancer Patients

用于优先考虑癌症患者药物的侧端口针阵列技术

• 批准号: 8294620
• 负责人: JAMES M OLSON
• 金额: $ 65.28万
• 依托单位: PRESAGE BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2014-08-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8294620
• 关键词: Address; Antibiotics; Biological Assay; Biological Sciences; Biotechnology; Businesses; Cancer Model; Cancer Patient; Caring; Clinical; Clinical Data; Clinical Trials; Community Clinical Oncology Program; Coupled; Data; Devices; Diagnosis; Drug Combinations; Drug Delivery Systems; Drug resistance; Drug toxicity; Engineering; Enrollment; Environment; Excision; Foundations; Frequencies; Funding; Goals; Grant; Heterogeneity; Hour; Human; In Vitro; Individual; Infection; Investigational Therapies; Journals; Letters; Lymphoma; Malignant Neoplasms; Manuscripts; Marketing; Medical Device; Medical Oncologist; Medicine; Methods; Mus; Nature; Necrosis; Needles; Operative Surgical Procedures; Outcome; Pathology; Patients; Pattern; Peer Review; Pharmaceutical Preparations; Phase; Phase I/II Trial; Physicians; Play; Publishing; Quality of Care; Research; Research Personnel; Resistance; Role; Running; Science; Scientist; Small Business Technology Transfer Research; Solid Neoplasm; Technology; Testing; Therapeutic; Toxic effect; United States; Work; base; cancer cell; cell behavior; chemotherapy; clinical practice; cohort; commercialization; drug candidate; drug sensitivity; experience; human data; improved; in vivo; meetings; oncology; pre-clinical; prototype; public health relevance; response; tumor

DESCRIPTION (provided by applicant): Over 90% of cancer patients that enroll in Phase I or II clinical trials experience no benefit from the experimental therapies, yet are exposed to drug toxicity and other challenges related to treatment. For over 50 years, physicians have used patient-specific information about drug resistance and sensitivity to select antibiotics for patients with infections, but this personalized approach has evaded the oncology community because cancer cell behavior in vitro drug sensitivity assays does not correlate with in vivo response to therapy in most cases. We have developed technologies that enable oncology drug sensitivity/resistance testing of multiple drugs or drug combinations in vivo during the days prior to surgical resection of a tumor. This approach allows drugs to interact with cancer cells while the latter are in their native tumor microenvironment. Our broad long-term goal is to develop reliable in vivo-based oncology drug sensitivity/resistance assays for patients with many types of solid tumors. Our overall goal of the STTR Phase I and II projects are to develop and test devices that are suitable for human lymphoma patients and to initiate human clinical trials. Our Specific Aim for the Phase I portion is to develop a single use (disposable) porous needle array and demonstrate that it meets drug delivery precision specifications. Provided that quantitative milestones are met in Phase I, Phase II will proceed with the following Aims: Aim 1) To develop a prototype suitable for use in human lymphoma patients; and Aim 2) to conduct a pilot "first in humans" clinical trial. The significance of the proposed work is that it will reduce the frequency of cancer patients being exposed to drugs that cause toxicity but offer no clinical benefit. The commercialization potential is described in a comprehensive business plan. We provide letters from highly respected individuals in the biotechnology, life sciences and personalized medicine fields to attest to the commercial potential of this technology. PUBLIC HEALTH RELEVANCE: Project Narrative It is estimated that approximately 1.4 million new cases of cancer will be diagnosed in the United States in 2008. Improved methods for prioritizing cancer therapeutics based on patient-based indicators of efficacy are needed. We are proposing to develop a device which enables comparison of multiple drugs or combinations in vivo, with the tumor micro-environment intact. The long-term goal of this research is to develop reliable in vivo- based oncology drug sensitivity/resistance assays for patients with many types of solid tumors. This technology will reduce the frequency of cancer patients being exposed to drugs that cause toxicity but offer no clinical benefit. This personalized treatment approach will improve patient outcome and enhance the quality of care for millions of individuals that suffer from cancer.

描述（由申请人提供）：超过90％的癌症患者参加了I期或II期临床试验的癌症患者，从实验疗法中没有任何好处，但仍受到药物毒性和与治疗相关的其他挑战。 50多年来，医生一直使用有关耐药性和敏感性的患者特异性信息来为感染患者选择抗生素，但是这种个性化的方法已经逃避了肿瘤学界，因为在大多数情况下，癌细胞的体外药物敏感性测定中的癌细胞行为与体内对治疗的反应无关。我们已经开发了在肿瘤手术切除前几天，可以使多种药物或药物组合对多种药物或药物组合进行肿瘤药物敏感性/耐药性测试。这种方法使药物可以与癌细胞相互作用，而后者则在其天然肿瘤微环境中。我们广泛的长期目标是为具有多种类型的实体瘤的患者开发可靠的基于体内的肿瘤学药物敏感性/耐药性测定。 STTR I和II阶段项目的总体目标是开发和测试适合人淋巴瘤患者并启动人类临床试验的设备。我们对I阶段部分的具体目的是开发一种用途（一次性）多孔针阵列，并证明它符合药物递送精度规格。只要在第一阶段达到定量里程碑，第二阶段将继续以下目的：目标1）开发适合于人淋巴瘤患者使用的原型；目标2）进行“人类首先”临床试验。拟议工作的重要性是，它将减少癌症患者暴露于引起毒性但没有临床益处的药物的频率。商业化潜力在综合商业计划中描述。我们在生物技术，生命科学和个性化医学领域提供了备受尊敬的人的来信，以证明这项技术的商业潜力。 公共卫生相关性：项目叙述据估计，2008年在美国将诊断出约140万例新的癌症病例。需要根据基于基于患者的功效指标来确定癌症治疗剂的改进方法。我们提议开发一种设备，该设备可以比较多种药物或体内的组合，并与肿瘤微环境完好无损。这项研究的长期目标是为具有多种类型的实体瘤的患者开发可靠的体内肿瘤药物敏感性/耐药性测定。该技术将减少癌症患者暴露于引起毒性但没有临床益处的药物的频率。这种个性化的治疗方法将改善患者的结果，并提高数百万患有癌症的人的护理质量。