RenovoRx Announces Promising Pharmacokinetic Data Using the TAMP™ Platform Presented at the 2026 ASCO Annual Meeting
Sub-Study from Ongoing Phase III TIGeR-PaC Clinical Trial Supports TAMP for Targeted Intra-Arterial Delivery of Gemcitabine, Demonstrating Potential to Increase Local Drug Potency and Reduce Systemic Exposure and Common Side Effects
MOUNTAIN VIEW, Calif., May 26, 2026 (GLOBE NEWSWIRE) -- 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 an abstract from a pharmacokinetic (PK) and pharmacodynamic sub-study of its ongoing Phase III TIGeR-PaC clinical trial has been published online in connection with the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29 – June 2, 2026.
The abstract, entitled "The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study," is a sub-study of the Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer. The abstract evaluates the TAMP (Trans-Arterial Micro-Perfusion) platform for targeted intra-arterial delivery of gemcitabine via RenovoCath, (the Company's lead investigational product candidate, known as IAG) and its potential to reduce systemic levels of gemcitabine and increase levels of its inactive metabolite compared with IV gemcitabine.
Results showed that IAG administration was associated with a direct correlation between 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 receiving gemcitabine via IV delivery for the treatment of pancreatic cancer. The PK and pharmacodynamic analyses were performed from a total of 16 patients across six TIGeR-PaC trial sites.
"This study suggests that enhancing local drug potency while reducing systemic exposure with IAG may increase efficacy while minimizing toxicity, addressing a key limitation of many therapies," said co-author Dr. Reza Nazemzadeh of Atrium Health Levine Cancer Institute, Charlotte, NC. "By lowering circulating drug levels, the approach has the potential to reduce side effects and improve patient tolerability, representing a promising step toward more precise and patient-centered cancer care."
The 2026 ASCO Annual Meeting is being held May 29 – June 2, 2026, in Chicago, Illinois.
Abstract Details:
Online Publication Date & Time: May 21, 2026, at 5:00 P.M. ET
Location: Online
Number for Publication: E16463
Title: The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study
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 select 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 RenovoRx, Inc.
RenovoRx, Inc. (NASDAQ:RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, 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™) 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 actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath sales and a record $563,000 of sales in the first quarter of 2026. RenovoRx is actively working to expand the number of medical institutions initiating new RenovoCath orders, including esteemed, high-volume National Cancer Institute-designated centers.
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, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx anticipates full enrollment in the TIGeR-PaC trial in June 2026 and final data readout in mid to late 2027.
The IAG combination product candidate, 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 described herein 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, including the anticipated benefits to the Company of the clinical study abstract described herein, (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 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," "aim," "goal," "estimates," "intends," and "potential," or derivatives of these terms or other comparable terminology regarding RenovoRx's statements about the future, 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 commercial sales efforts for RenovoCath and 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, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (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 scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage and reimbursement of our product candidates, if approved; and (xx) 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, which can be accessed at https://ir.renovorx.com/sec-filings.
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.
Investor Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T: 212-896-1254
RenovoRx@KCSA.com
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STiR Communications
Hannah Williams
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