RenovoRx TAMP Lowers Systemic Gemcitabine, Boosts Metabolite in 16-Patient Phase III Sub-Study
RNXT•In a 16-patient sub-study of the Phase III TIGeR-PaC trial across six sites, RenovoRx’s TAMP platform delivered intra-arterial gemcitabine via RenovoCath, lowering systemic drug levels and boosting its inactive metabolite. IAG treatment correlated metabolite increases with reduced CA 19-9, indicating improved local potency and fewer side effects.
1. Sub-Study Results
In the 16-patient PK/PD sub-study of the Phase III TIGeR-PaC trial across six sites, intra-arterial gemcitabine via RenovoCath reduced systemic gemcitabine concentrations and elevated levels of its inactive metabolite. A direct correlation emerged between metabolite rises and lowered CA 19-9 biomarker readings, suggesting enhanced local drug action compared with standard IV delivery.
2. TAMP Platform and RenovoCath Device
The Trans-Arterial Micro-Perfusion (TAMP) platform utilizes the FDA-cleared RenovoCath device to isolate arterial blood flow and deliver high concentrations of chemotherapy directly at the tumor site. This targeted approach aims to maximize local potency while minimizing systemic exposure and the adverse effects commonly seen with intravenous gemcitabine.
3. Clinical and Commercial Outlook
RenovoRx expects full enrollment in the TIGeR-PaC trial by June 2026, with final efficacy data projected in mid to late 2027. The company reported $1.1 million in RenovoCath sales in 2025 and $563,000 in the first quarter of 2026, and holds orphan drug exclusivity for intra-arterial gemcitabine upon potential FDA approval.
