RenovoRx Announces Publication Of Sub-Study Data From Its Ongoing Phase III TIGeR-PaC Clinical Trial In The Journal Cancer Chemotherapy And Pharmacology; Data Show Trans-Arterial Micro-Perfusion-Mediated Delivery Concentrated Chemotherapy At The Tumor Site, Extracting ~51% Of Drug Locally Before It Entered The Bloodstream, Meaningfully Lowering Systemic Exposure

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 the publication of pharmacokinetic and pharmacodynamic (PK/PD) data from a sub-study of its ongoing Phase III TIGeR-PaC clinical trial (NCT03257033) in the journal Cancer Chemotherapy and Pharmacology.

The data shows that TAMP (Trans-Arterial Micro-Perfusion)-mediated delivery concentrated chemotherapy at the tumor site, extracting roughly 51% of the drug locally before it entered the bloodstream, meaningfully lowering systemic exposure in a way that could reduce systemic side effects. In addition, a statistically significant correlation between the drug's local metabolism and a drop in the CA 19-9 tumor marker provided an early indication of improved drug penetration into the tumor area and potential tumor response with intra-arterial delivery.

RenovoRx also recently announced the closing of enrollment of the TIGeR-PaC trial, with trial completion expected in the first half of 2027 and expected initial top line data availability in the second half of 2027.

"The findings from this PK/PD study provide additional meaningful mechanistic support for our TAMP platform’s targeted drug-delivery approach," said Ramtin Agah, M.D., Executive Chairman, Chief Medical Officer, and Founder of RenovoRx. "The results provide direct pharmacokinetic evidence supporting TAMP’s potential to deliver chemotherapy more selectively to the tumor while limiting systemic exposure. These findings strengthen TAMP, enabled by our RenovoCath device, as a differentiated approach to improving the therapeutic index of chemotherapy in patients with LAPC."

The PK/PD study, titled "Pharmacokinetic and Pharmacodynamic Sub-study of Trans-arterial vs Intravenous Gemcitabine in the TIGeR-PaC Phase 3 Clinical Trial," compared the systemic drug levels of intra-arterial gemcitabine (IAG) delivered via TAMP using RenovoCath against standard intravenous gemcitabine (IVG) delivered systemically in 16 patients with LAPC across six clinical sites (11 patients received IAG; 5 received IVG). Funding for this study was provided by RenovoRx.

Key Findings:

• Reduced systemic exposure: IAG resulted in significantly lower total systemic gemcitabine exposure compared to IVG, despite being administered at a 50% higher infusion concentration rate, supporting the potential of TAMP to concentrate therapy at the intended treatment site while limiting systemic exposure.
• Substantial local drug extraction: A targeted extraction ratio of 0.511 was observed (derived from a bioavailability estimate of 0.489), indicating approximately 51% of the intra-arterially delivered gemcitabine was extracted at the site of intra-arterial delivery before entering systemic circulation. This finding provides direct pharmacokinetic evidence supporting the targeted drug-delivery mechanism underlying the TAMP platform.
• Tumor marker response: A statistically significant correlation was observed between higher systemic levels of dFdU and greater reductions in CA 19-9 tumor marker levels following IAG treatment (Pearson’s r = -0.75; P = 0.034; based on eight evaluable patients, with three excluded for normal baseline CA 19-9). dFdU is gemcitabine’s inactive metabolite, and higher dFdU levels are consistent with rapid local uptake and metabolism of gemcitabine at the treatment site, providing an initial pharmacodynamic signal linking drug exposure with a biomarker of tumor response.
• Consistent delivery across arterial sites: No statistically significant differences in gemcitabine or dFdU pharmacokinetic parameters were observed based on IAG delivery site, whether administered via the superior mesenteric artery or the celiac artery.
  
  
  
   

The Company believes this data provides evidence that IAG delivery via the TAMP therapy platform achieves meaningful local drug extraction while reducing systemic gemcitabine exposure, supporting RenovoRx’s differentiated approach to targeted intra-arterial chemotherapy in patients with LAPC.