On January 27, 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 an abstract presentation highlighting promising pharmacokinetic (known as PK) data from the use of RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform in treating locally advanced pancreatic cancer (LAPC) (Press release, Renovorx, JAN 27, 2025, View Source [SID1234649899]).
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The abstract was presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) 2025, by Paula Novelli, MD, University of Pittsburgh Medical Center, which is currently underway in San Francisco, CA.
Dr. Novelli, together with her co-authors, presented "Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial," a sub-study of RenovoRx’s ongoing pivotal Phase III TIGeR-PaC clinical trial in LAPC. In this sub-study, PK analyses were performed on a sample of participants across TIGeR-PaC study clinical sites. These analyses compared treatment with intra-arterial gemcitabine (IAG), using the RenovoCath delivery system via TAMP, versus systemic intravenous gemcitabine, which is the current standard of care for patients with LAPC.
Results of the sub-study showed RenovoRx’s IAG approach to drug delivery via TAMP decreased systemic levels of gemcitabine versus standard of care. In addition to providing increased local drug potency, the IAG approach may also be beneficial to decreasing gemcitabine-related systemic side effects. 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.
"Pancreatic cancer remains one of the most challenging cancers to treat, and this new data further highlights the potential of RenovoRx’s TAMP therapy platform as a transformative therapeutic option," said Paula Novelli MD, TIGeR-PaC Principal Investigator at University of Pittsburgh Medical Center. "TAMP is intended to direct a drug and more effectively target the tumor while minimizing systemic impact, and this sub-study shows that despite delivering more gemcitabine in a shorter time, the total systemic drug exposure was significantly lower compared to intravenous treatment. This data further demonstrates that TAMP has the potential to deliver gemcitabine to the tumor more efficiently, enhancing local treatment effectiveness while reducing the broader impact on the body, ultimately minimizing the systemic side effects of chemotherapy."
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 RenovoRx’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 early 2025. The second interim data readout is anticipated to occur by the end of the first half of 2025, with the timing for such readout, however, being dependent 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.
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.