Sideport Needle Array Technologies for Prioritizing Drugs for Cancer Patients

描述（由申请人提供）：超过90%参加I期或II期临床试验的癌症患者没有从实验疗法中获益，但暴露于药物毒性和其他与治疗相关的挑战。50多年来，医生一直使用患者特异性的耐药和敏感性信息来为感染患者选择抗生素，但这种个性化的方法一直回避肿瘤学界，因为在大多数情况下，癌细胞的体外药物敏感性测定与体内对治疗的反应并不相关。我们已经开发了一些技术，可以在手术切除肿瘤前的几天内，在体内对多种药物或药物组合进行肿瘤药物敏感性/耐药性测试。这种方法允许药物在癌细胞处于其原生肿瘤微环境时与癌细胞相互作用。我们广泛的长期目标是为多种类型的实体瘤患者开发可靠的基于体内的肿瘤药物敏感性/耐药试验。我们的STTR I期和II期项目的总体目标是开发和测试适合人类淋巴瘤患者的设备，并启动人体临床试验。我们第一阶段部分的具体目标是开发一次性（一次性）多孔针阵列，并证明它符合药物输送精度规范。如果在I期达到定量里程碑，II期将进行以下目标：目标1)开发适合用于人类淋巴瘤患者的原型；目标2)进行“首次人体”临床试验。这项工作的重要意义在于，它将减少癌症患者接触有毒性但没有临床益处的药物的频率。在全面的商业计划中描述商业化潜力。我们提供来自生物技术、生命科学和个性化医疗领域的德高望重人士的信函，以证明这项技术的商业潜力。

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.