RenovoRx publishes PK/PD data showing 51% tumour-site drug extraction
RenovoRx has highlighted the peer-reviewed publication of pharmacokinetic and pharmacodynamic (PK/PD) data from a sub-study of its ongoing Phase III TIGeR-PaC trial, with findings appearing in the journal Cancer Chemotherapy and Pharmacology. The Mountain View, California-based company said the data provides mechanistic support for its Trans-Arterial Micro-Perfusion (TAMP) platform, which delivers chemotherapy via intra-arterial catheter directly to the tumour site in patients with locally advanced pancreatic cancer (LAPC).
The sub-study compared intra-arterial gemcitabine (IAG) delivered through RenovoRx's FDA-cleared RenovoCath device against standard intravenous gemcitabine in 16 patients across six clinical sites. Eleven patients received IAG and five received intravenous gemcitabine. The study was company-funded.
What the data showed
The headline finding was a targeted extraction ratio of 0.511, indicating that roughly 51% of intra-arterially delivered gemcitabine was extracted at the local delivery site before entering systemic circulation. IAG also produced significantly lower total systemic drug exposure compared to intravenous administration, despite being infused at a 50% higher concentration rate. RenovoRx said this pattern is consistent with the platform's intended purpose: concentrating therapy at the tumour while reducing the body-wide toxicity burden associated with conventional systemic chemotherapy.
A secondary pharmacodynamic signal was also reported. A statistically significant correlation was observed between higher systemic levels of dFdU, the inactive metabolite of gemcitabine, and greater reductions in CA 19-9, a standard tumour marker for pancreatic cancer (Pearson's r = -0.75; P = 0.034; based on eight evaluable patients). The company interprets elevated dFdU as evidence of rapid local drug uptake and metabolism at the tumour site. Delivery site did not appear to influence pharmacokinetic parameters, with no significant differences seen between the superior mesenteric artery and the celiac artery as administration routes.
Ramtin Agah, Executive Chairman, Chief Medical Officer, and Founder of RenovoRx, said the results "provide direct pharmacokinetic evidence supporting TAMP's potential to deliver chemotherapy more selectively to the tumour while limiting systemic exposure."
Trial timeline and commercial context
RenovoRx confirmed that enrolment in TIGeR-PaC closed in August 2026. Trial completion is anticipated in the first half of 2027, with topline data expected in the second half of 2027. The company also noted that RenovoCath with gemcitabine holds Orphan Drug Designation for pancreatic cancer, which would confer seven years of market exclusivity on FDA approval.
The broader context here matters for investors and clinicians. Pancreatic cancer, and LAPC specifically, remains one of oncology's most refractory indications, with five-year survival rates below 15% across all stages. Standard of care for LAPC relies heavily on systemic gemcitabine-based regimens or FOLFIRINOX, both of which carry significant toxicity. A number of groups have explored loco-regional delivery strategies over the years, including irreversible electroporation and stereotactic body radiotherapy, though none has yet substantially shifted the prognosis for LAPC at scale. RenovoRx's intra-arterial approach sits within this broader effort to increase the therapeutic index of existing agents rather than develop entirely new molecular entities.
The PK/PD publication strengthens the mechanistic rationale ahead of the pivotal efficacy readout, but the sub-study's small patient numbers (16 total, eight evaluable for the pharmacodynamic correlation) mean the data is hypothesis-generating rather than conclusive. The Phase III topline results, due in the second half of 2027, will be the decisive test of whether the platform translates pharmacokinetic advantage into meaningful clinical benefit.