お知らせ • Aug 13
RenovoRx Achieves Full Enrollment in Phase III Tiger-Pac Trial for Locally Advanced Pancreatic Cancer
RenovoRx had completed enrollment in the Company’s Phase III TIGeR-PaC trial in locally advanced pancreatic cancer (LAPC). As of August 7, 2026, TIGeR-PaC trial investigators have been notified by RenovoRx that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial top line trial data is expected to be available during the second half of 2027. This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating intra-arterial gemcitabine (IAG) via RenovoCath delivered through RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) platform as a novel drug-device product candidate for difficult-to-treat LAPC. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane). Pancreatic cancer continues to represent a major unmet medical need, with limited treatment options and current standards of care centered largely on systemic chemotherapy, which can cause significant toxicity and related side effects for patients. TAMP is designed to deliver chemotherapy directly near the tumor site while potentially reducing systemic exposure. The study’s enrollment was supported by participation from nationally recognized cancer centers and academic medical institutions across the United States, including Johns Hopkins Medicine, University of Pittsburgh Medical Center, UT Southwestern Medical Center, University of Nebraska Medical Center, Baptist Health South Florida, Stephenson Cancer Center at the University of Oklahoma, and more. The study has also progressed through two independent interim analyses triggered following the 26th event in 2023 and the 52nd event in 2025, with the study’s independent Data Monitoring Committee (DMC) recommending continuation of the trial on both occasions. Together, these accomplishments reflect the successful execution of RenovoRx’s lead clinical program and support continued evaluation of its proprietary TAMP therapy 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. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx’s first investigational drug-device combination product candidate, using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath® device, is designed for the intra-arterial administration of chemotherapy, gemcitabine (IAG). RenovoRx is also evaluating its novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath, (known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. Full enrollment in the TIGeR-PaC trial was achieved in August 2026, with completion of the trial currently expected during the first half of 2027. Initial topline data readout is expected during the second half of 2027. The IAG combination product candidate, enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine 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.