Developing Innovative Targeted Oncology Therapies Based on a Local Drug-Delivery Platform
The 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 product candidate using the TAMP technology is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath® device. 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 of intra-arterial administration of chemotherapy, gemcitabine, versus systemic (intravenous (IV)) administration of gemcitabine and nab-paclitaxel.
RenovoRx’s patented 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 IV therapy. RenovoRx’s approach to targeted treatment offers the potential for increased safety and tolerance, as well as improved efficacy. The 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 device, which is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of gemcitabine by the RenovoCath device is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).
RenovoRx is also actively exploring other commercialization strategies utilizing its TAMP technology and RenovoCath as a stand-alone device.
RenovoRx is a life science company developing novel targeted oncology therapies based on a local drug-delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment.
