RenovoRx Presents Promising Pharmacokinetic Data for TAMP Therapy Platform at ASCO GI 2026
Key Insights
RenovoRx presented new pharmacokinetic and pharmacodynamic data from its Phase III TIGeR-PaC trial at ASCO GI 2026, demonstrating reduced systemic gemcitabine levels with intra-arterial delivery.
The sub-study of 16 patients showed that TAMP therapy with intra-arterial gemcitabine (search) resulted in increased levels of inactive metabolites and decreased CA 19-9 (search) biomarker levels compared to standard intravenous treatment.
The targeted drug-delivery approach may improve local drug potency while reducing chemotherapy-related side effects for patients with locally advanced pancreatic cancer (search).
RenovoRx presented promising new clinical data from its Trans-Arterial Micro-Perfusion (TAMP) therapy platform at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2026, demonstrating favorable pharmacokinetic profiles that could transform treatment for locally advanced pancreatic cancer (search) patients.
The abstract, titled "Intra-arterial Gemcitabine (search) 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 and presented data from a sub-study of RenovoRx's ongoing Phase III TIGeR-PaC clinical trial.
Key Clinical Findings
The pharmacokinetic and pharmacodynamic analyses evaluated 16 patients across six TIGeR-PaC clinical sites, with 11 patients treated with TAMP and intra-arterial gemcitabine (search) (IAG), and five patients receiving standard intravenous chemotherapy. The study compared the two delivery methods by measuring systemic drug exposure and peak plasma concentrations of gemcitabine for both treatment groups.
The data revealed that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its inactive metabolite compared with intravenous gemcitabine. Additionally, with IAG administration, researchers observed a direct correlation between the increased metabolite levels and reduced CA 19-9 (search), a biomarker commonly used to assess potential chemotherapy response.
"Pancreatic cancer (search) 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 drug-delivery."
Therapeutic Implications
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 (search). The new data show significantly lower systemic drug exposure compared to intravenous delivery and provide further evidence that TAMP and IAG may offer the potential to deliver treatment more efficiently.
Dr. Ramtin Agah, RenovoRx's Chief Medical Officer and one of the study's authors, noted that the clinical data abstract "further contributes to scientific basis for reported decreased clinical side effect profile with our approach to targeted drug-delivery via the TAMP therapy platform and IAG versus the standard of care, systemic intravenous therapy."
About the TIGeR-PaC Trial
The TIGeR-PaC trial is an ongoing Phase III randomized multi-center study evaluating RenovoRx's proprietary TAMP therapy platform for treating locally advanced pancreatic cancer (search). The 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.
RenovoRx's investigational drug-device combination product candidate uses the TAMP therapy platform enabled with the company's FDA-cleared RenovoCath device, designed for intra-arterial administration of gemcitabine. The combination product candidate has received Orphan Drug Designation for pancreatic cancer (search) and bile duct cancer (search), providing seven years of market exclusivity upon FDA approval.
Commercial Progress
RenovoRx is actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. The company received its first commercial purchase orders for RenovoCath devices in December 2024, and generated approximately $900,000 in revenues from RenovoCath sales during the first nine months of 2025. Several customers have initiated repeat orders while RenovoRx continues expanding to new medical institutions, including several National Cancer Institute-designated centers.