On January 8, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared delivery platform, reported three abstracts were accepted to be presented at several upcoming industry conferences including ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) 2025, Society of Interventional Oncology (SIO) 2025 and Society of Surgical Oncology (SSO) 2025 (Press release, Renovorx, JAN 8, 2025, View Source [SID1234649528]).
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The abstracts support RenovoRx’s novel and patented TAMP therapy platform via additional human PK data and pre-clinical data. TAMP is designed to ensure precise 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 therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.
RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating the Company’s first product candidate, a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of chemotherapy, gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025.
Abstract Details:
ASCO GI 2025
Title: Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial
Authors: Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Emmanuel Zervos MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
Location: Moscone West, San Francisco CA
Date/Time: January 24, 2025 at 11:30 a.m. PT
SIO 2025
Title: Micro-CT imaging following intra-arterial delivery of a radiopaque silicone polymer using a double-balloon occlusion catheter in pigs: a model to analyze tissue penetration via the trans-arterial micro perfusion (TAMP) technique
Authors: Paula Novelli MD, Christopher Laing MD, Aloke Finn MD, Frank Kolodgie PhD, Robert Strasser BSc, Ramtin Agah MD
Location: Horseshoe Las Vegas, Las Vegas NV
Date/Time: February 2, 2025 at 12:30 p.m. PT
SSO 2025
Title: Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial
Authors: Emmanuel Zervos MD, Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
Location: Tampa Convention Center, Tampa FL
Dates: March 27 – 29, 2025
The abstracts accepted at ASCO (Free ASCO Whitepaper) GI 2025 and SSO 2025 are sub-studies of the ongoing Phase III TIGeR-PaC clinical trial.
"These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system. This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor."
Dr. Agah added, "We also look forward to the completion of patient enrollment and our second interim analysis in our pivotal Phase III TIGeR-PaC clinical trial in LAPC by the end of the first half of 2025."
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 Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine.
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 study’s primary endpoint is an 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 (i.e., patient death), which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.