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

项目总结

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.