RenovoRx, a life sciences company developing innovative targeted oncology therapies and commercialising RenovoCath, a patented, FDA-cleared drug-delivery device, has announced the launch of the PanTheR Post-Marketing Registry Study (NCT06805461).
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The initiation of this study demonstrates RenovoRx’s commitment to innovation and RenovoCath’s current and future potential. The study will serve as a critical tool for understanding RenovoCath's safety and effectiveness in a real-world setting, providing valuable insights into long-term effectiveness and patient outcomes. Patient enrolment is expected to commence before the end of September 2025. Each cancer centre participating in the registry study will purchase RenovoCath devices for use in the study from RenovoRx.
A registry study, or post-approval study, is a clinical study that involves collecting data on the long-term use and performance of a medical device, such as RenovoCath, after it has been cleared for market by the FDA. PanTheR is a multi-centre, post-marketing observational registry study designed to evaluate the long-term safety of and survival outcomes for patients diagnosed with solid tumours who are treated using RenovoCath for targeted drug delivery. PanTheR will capture real-world data on the utilisation of RenovoCath and generate additional safety information across a broader range of solid tumours. This data may be used to inform future clinical trial designs.
The first of multiple clinical sites to initiate patient enrolment in the PanTheR study is the University of Vermont (UVM) Cancer Center, with Dr. Conor O’Neill, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, serving as Principal Investigator. Additional clinical sites in the post-marketing registry study are expected to initiate enrolment soon.
“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 centres 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.”
“We are very pleased that the UVM Cancer Center has been initiated to begin enrolment in the PanTheR study,” Ms. Gentry continued. “The UVM Cancer Center offers leading-edge care, provided by highly skilled oncologists priding themselves on using the latest research and education for informed care. We believe our study will be an excellent fit within University of Vermont’s oncology program.”
“We are proud to be part of this important study that holds the potential to transform the way we treat solid tumours,” said Dr. Conor O’Neill of the University of Vermont Cancer Center. “I believe the RenovoCath device offers a novel approach for drug delivery, which may have the potential to improve patient outcomes. This study emphasises 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 tumours.”