On March 28, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that a new human pharmacokinetic (PK) data abstract was presented at the Society of Surgical Oncology (SSO) 2025 Annual Meeting on March 27 – 29, 2025 in Tampa, FL: ePoster P379 (Press release, Renovorx, MAR 28, 2025, View Source [SID1234651595]).

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The abstract provides new human PK data relevant to RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform. TAMP is key to the Company’s Phase III investigational drug-device combination oncology product candidate (intra-arterial gemcitabine, with RenovoCath, known as IAG) and is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapies. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

The abstract, titled "Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial," was authored by Emmanuel E. Zervos, M.D. of East Carolina University, and co-authored by Ramtin Agah, M.D., founder and Chief Medical Officer of RenovoRx and others.

"The data presented in this abstract support the potential for the TAMP therapy platform to provide a meaningful advancement in the standard of care for oncology therapy in difficult-to-treat tumors," said Dr. Zervos. "This study shows additional support for TAMP as a potential treatment option in locally advanced pancreatic cancer (LAPC). Specifically, in this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels of gemcitabine compared to intravenous gemcitabine. IAG may prove beneficial in decreasing chemotherapy-related systemic side effects. We are awaiting final outcomes in the ongoing Phase III TIGeR-PaC clinical trial for IAG to validate this benefit."

PK analyses were performed on 19 patients with locally advanced pancreatic cancer receiving IAG from six sites as part of the TIGeR-PaC trial. In this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous delivery of gemcitabine. As such, the study found that IAG may be beneficial in decreasing chemotherapy-related systemic side effects. Correlative patient reported outcomes in patients receiving IAG supports this approach as an alternative for LAPC patients who are having difficulty tolerating more traditional systemic regimens.

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 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. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

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 LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine (IAG).