RenovoRx Showcases Promising Pharmacokinetic Data at ASCO GI 2025

Introduction to RenovoRx and Its Innovative TAMP™ Therapy

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company dedicated to revolutionizing oncology treatment, recently shared compelling data from its novel therapeutic platform at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) 2025. The presentation focused on promising pharmacokinetic (PK) findings from the use of the Company’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform in treating locally advanced pancreatic cancer (LAPC). The highlight of the study emphasizes the potential of this groundbreaking technology to improve treatment efficacy while reducing systemic toxicity.

Addressing the Challenges of Pancreatic Cancer Treatment

Pancreatic cancer remains one of the most difficult cancers to treat, with limited advancements in therapeutic options over the years. Dr. Paula Novelli, TIGeR-PaC Principal Investigator at the University of Pittsburgh Medical Center, stated, “This new data further highlights the potential of RenovoRx’s TAMP therapy platform as a transformative therapeutic option.” The presentation at ASCO GI showcased how TAMP can improve local drug delivery and efficacy, offering new hope for patients with LAPC.

Presentation Details at ASCO GI 2025

The abstract titled “Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial” was presented by Dr. Paula Novelli and her co-authors. This study is a sub-study of RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial, designed to evaluate the effectiveness of TAMP therapy compared to the current standard of care.

Study Design and Methodology

The TIGeR-PaC trial’s pharmacokinetic sub-study analyzed treatment outcomes for a sample of participants across multiple clinical sites. The key comparison was between:

  • Intra-arterial gemcitabine (IAG): Delivered through the RenovoCath® system via TAMP, this method directs chemotherapy to the tumor site with high precision.
  • Intravenous gemcitabine (IV): The current standard of care for LAPC, which delivers chemotherapy systemically.

By examining PK data, the study aimed to determine whether the TAMP platform could enhance localized drug delivery while minimizing systemic exposure.

Key Findings and Outcomes

The results of the sub-study were compelling:

  1. Reduced Systemic Drug Levels: The TAMP approach demonstrated significantly lower systemic levels of gemcitabine compared to intravenous administration. This suggests that the therapy minimizes the overall exposure of chemotherapy to the body, potentially reducing systemic side effects.
  2. Enhanced Local Drug Potency: The intra-arterial delivery via TAMP allowed for higher concentrations of gemcitabine to reach the tumor site. This targeted delivery method may improve the effectiveness of chemotherapy directly at the tumor.
  3. Reduced Systemic Toxicity: By decreasing systemic drug levels, the TAMP platform has the potential to lessen chemotherapy-related side effects, which are often a major concern for cancer patients undergoing treatment.

The Science Behind TAMP™ Therapy

RenovoRx’s TAMP therapy platform is designed to optimize therapeutic delivery. The process involves precise administration of drugs across the arterial wall near the tumor, ensuring that the tumor is bathed in chemotherapy while sparing the rest of the body. This novel approach contrasts sharply with traditional systemic therapies, which circulate throughout the body and often lead to significant toxicities.

Dr. Novelli elaborated on the significance of this approach: “TAMP is intended to direct a drug and more effectively target the tumor while minimizing systemic impact. Despite delivering more gemcitabine in a shorter time, the total systemic drug exposure was significantly lower compared to intravenous treatment.”

Implications for the Future of Oncology

The data presented at ASCO GI underscores the potential of the TAMP platform to revolutionize pancreatic cancer treatment. The ability to enhance local drug delivery while reducing systemic toxicity could pave the way for more effective and less burdensome cancer therapies. Additionally, these findings may have implications beyond pancreatic cancer, as TAMP could potentially be adapted for other solid tumors.

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.

About RenovoRx, Inc.

RenovoRx is a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery platform, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform 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, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.

RenovoRx’s Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of chemotherapy, gemcitabine, utilizing the RenovoCath catheter is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA).

The intra-arterial infusion of gemcitabine by the RenovoCath catheter 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 7 years of market exclusivity upon NDA approval by the FDA.

RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, over ten medical institutions have initiated the process for RenovoCath purchase orders. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner

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