On March 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the Company has achieved a key milestone in its ongoing Phase III TIGeR‑PaC clinical trial by surpassing 100 randomized patients and remains on track for enrollment completion in the first half of 2026, with final data expected in 2027.
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"Reaching over 100 randomized patients marks an important milestone in our Phase III trial as we maintain strong momentum toward enrollment completion. We remain committed to completing the TIGeR-PaC trial and delivering final data in 2027," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "In parallel, select TIGeR-PaC cancer centers have begun using the TAMP therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors."
RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) is being evaluated in the 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, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. TIGeR-PaC is evaluating IAG in locally advanced pancreatic cancer, and its potential to minimize a therapy’s toxicities versus systemic intravenous therapy.
The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the end of the first half of 2026, ensuring a minimum of 114 patients will be randomized.
The first and second pre-planned interim analyses were conducted per protocol specifications and triggered upon the 26th event (2023) and the 52nd event (2025), respectively. In both the first and second interim analyses, the independent data monitoring committee (DMC) for the trial recommended that RenovoRx continue with the trial, based on its review of the data.
About RenovoCath
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 select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.
(Press release, Renovorx, MAR 26, 2026, View Source [SID1234663962])