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

癌症是美国第二大死因，食道癌的存活率在所有癌症中排名第六。全身药物治疗是广泛转移的食道癌的一线治疗方法，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、管子、加热元件和药物洗涤液组成。一项概念验证动物研究表明，当药物溶液在食管腔内输送时，Isola可以直接将药物输送到食道组织，同时通过使用气球将食道与胃肠道隔离，将血浆中的药物降至最低。其目标是治疗食道癌(腺癌和鳞癌)，同时将全身药物暴露和毒性降至最低。这项建议的目的是通过a)最终完成药物输送系统的设计并选择理想的药物输送，以推进最终完成使用ISOLA药物输送系统的人类(FIH)研究的活动，b)完成装置设计验证和生物相容性测试，以在人体上使用药物输送系统，以及c)进行比较慢性动物研究，将ISLA药物输送与标准静脉给药进行比较。

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.