Northwell Health Cancer Institute (NHCI) in New Hyde Park, NY, has begun enrolling patients in RenovoRx's pivotal Phase III TIGeR-PaC clinical trial. The trial is evaluating RenovoRx's Trans-Arterial Micro-Perfusion (TAMP) therapy platform for treating locally advanced pancreatic cancer (LAPC). This marks a significant step in assessing a novel approach to targeted chemotherapy delivery.
TIGeR-PaC Trial Details
The TIGeR-PaC study is a randomized, multi-center trial assessing the TAMP therapy platform, which combines RenovoRx’s FDA-cleared RenovoCath device with intra-arterial gemcitabine administration. TAMP aims to deliver gemcitabine directly to the tumor site using pressure-mediated delivery, potentially enhancing efficacy while minimizing systemic side effects. The trial compares TAMP to the current standard-of-care, systemic intravenous chemotherapy, in patients with LAPC.
Expert Commentary
Dr. Daniel King, MD, PhD of Medical Oncology at NHCI, stated, “We are pleased to be part of this pivotal study that holds the potential to transform the way we treat pancreatic cancer. TAMP represents a novel approach to targeted chemotherapy delivery near the tumor site, which may improve efficacy while reducing systemic side effects. This study underscores our deep commitment to advancing cancer treatment and offering our patients access to the latest in therapeutic innovations.”
Leesa Gentry, Chief Clinical Officer of RenovoRx, added, “Working with New York’s largest healthcare system is a major win for RenovoRx. We believe this collaboration will assist the Company in both accelerating patient enrollment in our pivotal Phase III TIGeR-PaC clinical trial and driving the study towards its expected enrollment completion in the first half of 2025.”
Locally Advanced Pancreatic Cancer (LAPC)
LAPC is diagnosed when pancreatic cancer has not spread far beyond the pancreas but is too advanced for surgical removal. According to the American Cancer Society, pancreatic cancer has a 5-year survival rate of 13% and is projected to become the second leading cause of cancer-related deaths by 2030. LAPC typically corresponds to Stage 3 of the disease, as determined by the TNM (tumor, nodes, and metastasis) grading system.
RenovoCath and TAMP Technology
RenovoCath is FDA-cleared for isolating blood flow and delivering fluids, including diagnostic and therapeutic agents, to selected sites in the peripheral vascular system. It is also indicated for temporary vessel occlusion in applications such as arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
The TAMP therapy platform is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site, potentially minimizing toxicities compared to systemic intravenous therapy. RenovoRx's approach aims to improve safety, tolerance, and efficacy in cancer treatment.
Trial Status and Future Expectations
The first interim analysis of the TIGeR-PaC trial was completed in March 2023, with the Data Monitoring Committee recommending the study's continuation. The primary endpoint is overall survival benefit, with secondary endpoints including reduced side effects compared to standard of care. The second interim analysis is expected in late 2024 or early 2025, triggered by the 52nd patient death, with the data readout following thereafter. RenovoRx aims to complete patient enrollment in the first half of 2025.
