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.
Public Health Relevance Statement: PROJECT NARRATIVE Advanced Chemotherapy Technologies (ACT) has developed a proprietary implantable iontophoretic device that facilitates the infusion of chemotherapy agents directly into the cancer they are intended to reach, minimizing toxic exposure to the vascular system and other organs. In this application, ACT is focusing specifically on treating pancreatic cancer with gemcitabine. ACT proposes to redesign the preclinical device to ensure compatibility of use in human subjects, perform all device related verification testing for IND submission, and test in limited First-in-Human trials. The proposed studies will serve as a critical step in product development and assessment of the safety of the iontophoretic infusion of gemcitabine into the pancreas.
Project Terms: Address; Animal Model; Animal Testing; Australia; base; biomaterial compatibility; Blood Vessels; Cancer Patient; Canis familiaris; Catheters; chemotherapeutic agent; chemotherapy; Clinical; Clinical Protocols; Clinical Trials; Country; density; design; Device Designs; Device or Instrument Development; Device Safety; Devices; Diagnosis; Disease; Drug Combinations; Drug Delivery Systems; Drug Targeting; Drug usage; Effectiveness; efficacy testing; Ensure; Exposure to; Gel; gemcitabine; Growth; Human; human study; human subject; Implant; implantable device; implantation; improved; in vivo; Infusion procedures; International; Investigational Drugs; Investigational New Drug Application; Iontophoresis; Japan; Korea; Legal patent; Location; Malignant neoplasm of pancreas; Malignant Neoplasms; manufacturing process; Mechanics; meetings; Methods; Modeling; mouse model; Nerve; novel; novel strategies; Operative Surgical Procedures; Organ; Pancreas; Pancreatic Adenocarcinoma; Patients; performance tests; Persons; Pharmaceutical Preparations; Phase; phase 2 study; pre-clinical; preclinical study; Preclinical Testing; product development; Production; Protocols documentation; prototype; Reporting; research clinical testing; Resectable; Safety; safety testing; Sepharose; Skin; sterility testing; Structure; Study Subject; Survival Rate; systemic toxicity; targeted delivery; Technology; Test Result; Testing; Time; Toxicant exposure; tumor; Tumor Expansion; United States Food and Drug Administration; Vascular System; Xenograft Model; Xenograft procedure
