Implantable iontophoresis chemotherapy delivery device for direct infusion of gemcitabine into pancreatic adenocarcinoma: Device development and First-in-Human clinical trial

项目摘要 先进的化疗技术（ACT）开发了一种专有的植入式离子电渗设备 这有助于化疗药物直接输注到癌症肿瘤中，最大限度地减少毒性暴露， 血管系统和其他器官。ACT专注于治疗胰腺癌， 吉西他滨对此提案。胰腺癌的五年生存率不到7%， 手术是治愈的唯一机会40%的患者因肿瘤扩大而不适合手术 进入附近的主要血管或神经。ACT将植入该装置，该装置使用 离子电渗原理，直接进入肿瘤，并通过一个连接设备到体外的身体。 导管终止于皮肤端口。ACT设计了一种临床前器械，用于广泛的工作台， 动物试验，并将调整设计用于临床试验。动物模型几乎没有表现出 当使用离子电渗法将药物递送靶向至胰腺时， 肿瘤明显消退在该申请中，ACT建议重新设计临床前器械并开发 生产临床器械并进行安全性和有效性测试的GMP制造流程，以确保 该装置对于人类使用是安全的。这项申请将包括一个有限的小型首次人体试验， 评估将吉西他滨离子导入胰腺的安全性。拟议的研究将有助于 作为器械开发和靶向递送的概念验证的关键步骤， 通过所述装置增加化学治疗剂到达目标的能力，同时减少化学治疗剂的剂量。 系统性影响。

PROJECT SUMMARY Advanced Chemotherapy Technologies (ACT) has developed a proprietary implantable iontophoretic device that facilitates the infusion of chemotherapy agents directly into a cancer tumor, minimizing toxic exposure to the vascular system and other organs. ACT is focusing specifically on treating pancreatic cancer with gemcitabine for this proposal. Pancreatic cancer has a five-year survival rate of less than 7% and relies on surgery as the only opportunity for a cure. 40% of patients are not eligible for surgery due to tumor expansion into nearby major blood vessels or nerves. ACT will implant the device, which delivers the drug using iontophoresis principles, directly into the tumor, and connect the device to the outside of the body through a catheter terminated in a skin port. ACT has designed a pre-clinical device used in extensive bench top and animal testing and will adapt the design for clinical testing. The animal models demonstrated very little systemic gemcitabine delivery when using iontophoresis to target drug delivery to the pancreas while showing marked tumor regression. In this application, ACT proposes to redesign the preclinical device and develop GMP manufacturing processes to produce clinical devices and conduct safety and efficacy testing to ensure the device is safe for human use. This application will include a limited small first-in-human trial that will assess the safety of iontophoretic infusion of gemcitabine into the pancreas. The proposed studies will serve as a critical step in device development and proof-of-concept demonstration of the targeted delivery of the chemotherapeutic agents by the device increasing the ability of the agent to reach the target while decreasing systemic impact.