RenovoRx, Inc. announced that the University of Nebraska Medical Center (UNMC) is now enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in the Company?s ongoing pivotal Phase III TIGeR-PaC clinical trial. The TIGeR-PaC study is using RenovoRx?s patented TAMP (Trans-Arterial Micro-Perfusion) therapy platform to evaluate its RenovoGem investigational drug-device combination product. RenovoGem utilizes pressure-mediated delivery of chemotherapy across the arterial wall to bathe tumor tissue.

The study is comparing treatment with TAMP to the current standard-of-care (systemic intravenous chemotherapy). TIGeR-PaC is an ongoing Phase III 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, RenovoGem?, is a novel oncology drug-delivery combination utilizing TAMP administration technology combined with the FDA-approved chemotherapy, gemcitabine.

The study is comparing treatment with TAMP to the current standard of care of systemic intravenous chemotherapy. The TIGeR-PaC clinical trial is currently enrolling unresectable LAPC patients at esteemed cancer center sites across the United States. The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study.

The TIGeR-PaC study is investigating TAMP in LAPC. The study's primary endpoint is a 6-month Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event, which is estimated to occur in late 2024.

According to American Cancer Society?s Cancer Facts & Figures 2023, pancreatic cancer has a 5-year combined overall survival rate of 13% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond the pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in Stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.