RenovoRx, Inc. (Nasdaq: RNXT) has announced the launch of the PanTheR Post-Marketing Registry Study (NCT06805461), a multi-center observational study designed to evaluate the long-term safety and real-world effectiveness of the company's FDA-cleared RenovoCath drug-delivery device in treating solid tumors. Patient enrollment is expected to commence before the end of September 2025, with participating cancer centers purchasing RenovoCath devices from RenovoRx for use in the study.
Study Design and Objectives
PanTheR is a multi-center, post-marketing observational registry study that will collect data on the long-term use and performance of RenovoCath after its FDA clearance. The study aims to capture real-world data on the utilization of RenovoCath and generate additional safety information across a broader range of solid tumors. This data may be used to inform future clinical trial designs and provide valuable insights into long-term effectiveness and patient outcomes.
"PanTheR marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our RenovoCath device," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "By collaborating with leading cancer centers across the U.S, this is a low-cost study that will yield valuable data. By gathering real-world data across diverse cancer types and clinical environments, PanTheR aims to advance innovation and inform evidence-based treatment strategies, which will ultimately enhance care and potentially improve outcomes for future patients facing solid tumors."
Clinical Site Participation
The University of Vermont (UVM) Cancer Center will be the first clinical site to initiate patient enrollment in the PanTheR study. Dr. Conor O'Neill, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, will serve as Principal Investigator. Additional clinical sites in the post-marketing registry study are expected to initiate enrollment soon.
"We are proud to be part of this important study that holds the potential to transform the way we treat solid tumors," said Dr. O'Neill. "I believe the RenovoCath device offers a novel approach for drug delivery, which may have the potential to improve patient outcomes. This study emphasizes our strong commitment to continually advance treatment options offered to our patients by offering access to the latest innovations that have the potential to transform the treatment paradigm for solid tumors."
RenovoCath Technology Platform
Based on its FDA clearance, 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 device is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform is designed for 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 intravenous therapy. The company's novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.
Commercial and Development Pipeline
In addition to the RenovoCath device, RenovoRx is evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG utilizes RenovoCath and has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.
RenovoRx has also been implementing commercialization strategies for its FDA-cleared RenovoCath as a stand-alone device. In December 2024, the company announced receipt of its first commercial purchase orders for RenovoCath devices, with several customers initiating repeat orders while RenovoRx expands to new medical institutions, including several esteemed, high-volume National Cancer Institute-designated centers.
