Trans-Arterial Micro-perfusion (TAMP™) is an Innovative Therapy Platform Designed for Targeted Delivery of Existing and Novel Oncology Agents to Tumors
Our proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway.
The investigational drug-device combination candidate utilizes RenovoCath®, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of gemcitabine by RenovoCath is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA).
Learn more about TAMP by watching this animation:
Localized and Targeted Therapy
The therapeutic approach of TAMP is specifically designed for the localized and targeted delivery of chemotherapy via the peripheral vascular system. Our patented delivery system is inserted into an artery that runs adjacent to the tumor via an approximately 4 mm incision made in the patient’s leg. RenovoCath’s double balloon design enables the physician to isolate sections of the blood vessel through the adjustment of the distance between the balloons, thereby excluding any side branches in order to create the pressure head needed to push chemotherapy across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy.
Standard of care for patients diagnosed with most forms of cancer is intravenous systemic chemotherapy, which typically has significant side effects and can be limited in its effectiveness based on cancer type. For example, liver cancer tumors are highly vascularized and typically have large tumor feeders or blood vessels connected to the tumor, making them better candidates for systemic chemotherapy because medicine is able to gain direct access to the tumor. In contrast, pancreatic cancer tumors lack visible tumor feeder blood vessels, which means the chemotherapy circulates through the body, without a significant amount of medicine reaching the tumor.
Targeted Delivery In Action
The first of two interim analyses was completed in March 2023, and the DMC recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month OS benefit and secondary endpoints including reduced side effects versus standard of care.
Caution: Federal (USA) law restricts this system to sale by or on the order of a physician.
The RenovoRx delivery system (“RenovoCath”) is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoRx delivery system is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. Prior to use, please refer to the RenovoRx IFU for complete product indications, warnings, precautions, contraindications, potential adverse effects and detailed instructions for use.