Northwell Health Cancer Institute (NHCI) has joined RenovoRx's pivotal Phase III TIGeR-PaC clinical trial, marking a significant step in the treatment of locally advanced pancreatic cancer (LAPC). The trial is designed to evaluate RenovoRx's TAMP (Trans-Arterial Micro-Perfusion) therapy platform, comparing the efficacy of intra-arterial gemcitabine delivery via the FDA-cleared RenovoCath system against standard intravenous chemotherapy.
TIGeR-PaC Trial Details
The TIGeR-PaC study is a randomized, multi-center Phase III trial. It aims to determine whether TAMP can offer an overall survival benefit and reduce side effects compared to the current standard of care for LAPC, which is systemic intravenous chemotherapy. The study's primary endpoint is overall survival, with secondary endpoints focusing on the reduction of side effects.
The first interim analysis, completed in March 2023, led the Data Monitoring Committee to recommend the continuation of the study. The second interim analysis is event-driven, triggered by the 52nd patient death, expected in late 2024 or early 2025. The data readout will follow, depending on the time needed for analysis. RenovoRx anticipates completing patient enrollment in the first half of 2025.
TAMP Therapy Platform
The TAMP platform employs pressure-mediated delivery of gemcitabine directly to the tumor site through the RenovoCath system. This targeted approach aims to maximize drug concentration at the tumor while minimizing systemic exposure, potentially improving efficacy and reducing systemic side effects.
Northwell Health's Role
NHCI, a major cancer center in the United States and New York's largest healthcare system, will enroll patients with LAPC in the TIGeR-PaC trial. Dr. Daniel King, MD, PhD of Medical Oncology at NHCI, stated, "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."
Pancreatic Cancer Statistics
Pancreatic cancer remains a formidable challenge, with a 5-year overall survival rate of just 13%. It is projected to become the second leading cause of cancer-related deaths before 2030. LAPC, diagnosed when the cancer has not spread far beyond the pancreas but is too advanced for surgical removal, typically corresponds to Stage 3 of the disease.
About RenovoCath
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.
Company's Perspective
Leesa Gentry, Chief Clinical Officer of RenovoRx, commented, "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."
