Developing Innovative Targeted Oncology Therapies and Commercializing RenovoCath®, a Novel, FDA-cleared Drug-Delivery Device
Our Phase III TIGeR-PaC clinical trial is an ongoing randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx’s first investigational drug-device combination oncology product candidate uses the TAMP therapy platform enabled by the Company’s FDA-cleared RenovoCath device and is designed for the intra-arterial administration of chemotherapy, gemcitabine (IAG). RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, such as chemotherapeutic drug infusion, to selected sites in the peripheral vascular system. The study is comparing treatment with the combination oncology product candidate, IAG, versus systemic (intravenous (IV)) administration of gemcitabine and nab-paclitaxel.
Our patented TAMP therapy platform is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic IV therapy. This novel approach to targeted treatment offers the potential for increased safety and tolerance, as well as improved efficacy. RenovoCath, the Company’s FDA-cleared device, enables the TAMP therapy platform. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
The investigational combination oncology product candidate, IAG, utilizes RenovoCath. The combination oncology product candidate is currently being evaluated for the treatment of LAPC under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The combination product candidate, enabled the RenovoCath device, is currently under investigation and has not been approved for commercial sale.
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and RenovoCath as a stand-alone device.
RenovoRx is a life sciences company developing innovative targeted oncology therapies and commercializing the RenovoCath device, targeting high unmet medical needs. Our novel approach to targeted treatment offers patients with solid tumor cancers, the potential for increased safety, tolerance, and improved efficacy. Our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
