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New Pharmacokinetic (PK) and Pharmacodynamic Data from Sub-Study in Phase III Trial Strengthens Scientific Basis for RenovoRx's TAMP Therapy Platform as a Targeted Drug-Delivery Approach
Data Shows a PK Profile that May Improve Clinical Efficacy and Decrease Clinical Side Effects with TAMP and Intra-Arterial Gemcitabine Versus Standard of Care Chemotherapy
XEvKfAkjTnvnl1NNTCdjtJfmOg==" target="_blank" rel="nofollow">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, today announced that a new clinical data abstract from a pharmacokinetic (PK) and pharmacodynamic sub‑study of its ongoing Phase III TIGeR‑PaC clinical trial will be presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2026 ("ASCO GI"), being held today through January 10th in San Francisco, California.
The abstract, titled "Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial," was led by Dr. Paula M. Novelli of the University of Pittsburgh Medical Center (UPMC). The data presented is from a sub-study of RenovoRx's ongoing Phase III TIGeR-PaC clinical trial (NCT03257033), which is evaluating the use of intra-arterial gemcitabine (IAG), a drug-device combination product candidate that uses the Company's patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform, in treating locally advanced pancreatic cancer (LAPC).
The abstract concludes that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its inactive metabolite compared with IV gemcitabine. Also, with IAG administration, a direct correlation was observed between the increased metabolite levels and reduced CA 19-9, a biomarker commonly used to assess potential chemotherapy response. By decreasing systemic levels of gemcitabine, through limited systemic exposure and rapid conversion to an inactive metabolite, this drug-delivery approach may both increase local drug potency and reduce the negative side effects common to patients with pancreatic cancer.
"Pancreatic cancer remains one of the most challenging cancers to treat. These new data presented at ASCO GI further emphasize the potential of TAMP and IAG to provide a transformative therapeutic option for patients," said Dr. Novelli. "TAMP and IAG are intended to target chemotherapy very near the actual tumor site, rather than injecting it systemically into the body via intravenous (IV) drug-delivery. These new data show significantly lower systemic drug exposure compared to IV and provide further evidence that TAMP and IAG may offer the potential to deliver treatment more efficiently, improving local effectiveness while minimizing chemotherapy-related side effects."
The sub-study is co-authored by a multidisciplinary team representing leading academic institutions and cancer centers, including Brody School of Medicine at East Carolina University, Levine Cancer Institute, Sarasota Memorial Health Care System, University of Iowa Carver College of Medicine, University of Oklahoma College of Medicine, and UPMC.
Illustration of Targeted Chemotherapy Delivery via the TAMP Therapy Platform
The sub-study's pharmacokinetic and pharmacodynamic analyses evaluated 16 patients across six TIGeR-PaC clinical sites, of which 11 patients were treated with TAMP and IAG, and five patients were treated with IV administration of the chemotherapy, which is the current standard of care for patients with LAPC. The study compared the two delivery methods by measuring systemic drug exposure and peak plasma concentrations of gemcitabine for both treatment groups.
Read full clinical data abstract: https://www.asco.org/abstracts-presentations/257226.
The TIGeR-PaC trial is currently enrolling and aims to determine the impact of IAG on the study's primary endpoint of Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care.
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.-G-Universal-IFU.pdf.
About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx's first investigational drug-device combination product candidate, using the TAMP therapy platform enabled with the Company's FDA-cleared RenovoCath® device, is designed for the intra-arterial administration of chemotherapy, gemcitabine (IAG).
About RenovoRx, Inc.
RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for 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 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 is in the early stages of actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices, and for the first nine months of 2025, approximately $900,000 of revenues were generated from RenovoCath sales. Several customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. 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.
RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) in the ongoing Phase III 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.
The IAG combination product candidate, which is enabled by the RenovoCath device, 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 seven years of market exclusivity upon new drug application approval by the FDA.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company's management made in connection therewith contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control, and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections, and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives, and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as "may," "expects," "plans," "aims," "anticipates," "believes," "forecasts," "estimates," "intends," and "potential," or the negative of these terms or other comparable terminology regarding RenovoRx's expectations strategy, plans, or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding-; (iii) the timing of the initiation, progress, and potential results (including the results of interim analyses) of our preclinical studies, clinical trials, and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate-;(v) that the applicable regulatory authorities may disagree with our interpretation of the data-, research, and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that we file from time to time with the Securities and Exchange Commission.
Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T: 212-896-1254
RenovoRX@KCSA.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d2d1c6df-94d5-4063-86e1-b687bcc86c2f
