PHASE I -TOPIC 431 - DRUG DELIVERY BY ENDOESOPHAGEAL LAVAGE (EEL) TO TREAT ESOPHAGEAL CANCER

第一阶段 - 主题 431 - 通过食管内灌洗 (EEL) 给药治疗食管癌

• 批准号: 10792456
• 负责人: CRAIG BRIAN
• 金额: $ 5.5万
• 依托单位: ISOLA THERAPUETICS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2023-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10792456
• 关键词: Adenocarcinoma Cell; Animals; Cancerous; Catheters; Cause of Death; Chronic; Device Designs; Drug Delivery Systems; Drug Exposure; Drug toxicity; Drug usage; Elements; Eligibility Determination; Esophageal Tissue; Esophagus; Family suidae; Goals; Heating; Human; Intravenous; Irrigation; Malignant Neoplasms; Malignant neoplasm of esophagus; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Plasma; Squamous cell carcinoma; Survival Rate; System; Testing; Tube; United States; biomaterial compatibility; comparative; cost; design; design verification; first-in-human; gastrointestinal; human study; metastatic esophageal; systemic toxicity; tumor

Cancer is the second leading cause of death in the United States and esophageal cancer has the 6th lowest survival rate for all cancers. Systemic drug therapy is first-line therapy for widely metastatic esophageal cancer, but is limited by systemic toxicity, patient eligibility, or cost. The proprietary Isola system consists of a drug delivery catheter, tubing, heating element, and a drug lavage solution. A proof-of concept animal study demonstrated that Isola can deliver drug directly to esophageal tissue while minimizing drug in plasma by using balloons to isolate the esophagus from the gastrointestinal track when a drug solution is delivered in the lumen of the esophagus. The goal of is to treat cancerous tumors (adenocarcinoma and squamous cell carcinoma) in the esophagus while minimizing systemic drug exposure and toxicity. The objective of this proposal is to advance activities to eventually complete a first in human (FIH) study using the Isola drug delivery system by a) finalizing the drug delivery system design and selecting the ideal drug for delivery b) completing device design verification and biocompatibility testing to use drug delivery system in humans and c) conducting comparative chronic animal studies to compare Isola drug delivery to standard intravenous drug delivery.

癌症是美国的第二大死亡原因，食管癌的生存率在所有癌症中排名第六。全身药物治疗是广泛转移性食管癌的一线治疗，但受到全身毒性、患者资格或成本的限制。专有的Isola系统由药物输送导管、管路、加热元件和药物灌洗液组成。一项概念验证动物研究表明，Isola可将药物直接输送至食管组织，同时通过在食管腔内输送药物溶液时使用球囊将食管与胃肠道隔离，最大限度地减少血浆中的药物。 的目标是治疗食管癌性肿瘤（腺癌和鳞状细胞癌），同时最大限度地减少全身药物暴露和毒性。 本提案的目的是推进活动，以最终完成使用Isola给药系统的首次人体（FIH）研究，具体方法是：a）完成给药系统设计并选择理想的给药药物B）完成器械设计验证和生物相容性试验，以便在人体中使用给药系统，以及c）进行比较性慢性动物研究，以比较Isola药物递送与标准静脉内药物递送。