California medical device company RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) system has shown potential for improved drug potency with fewer side effects in a sub-study of a Phase III trial in patients living with locally advanced pancreatic cancer (LAPC).
Presented as part of the ASCO Gastrointestinal Cancers Symposium (ASCO GI) 2025 in San Francisco, pharmacokinetic (PK) data found that drug delivery via the company’s TAMP system decreased systemic levels of gemcitabine versus the intravenous standard of care. Gemcitabine is a chemotherapy used to treat several cancers.
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The ongoing IGeR-PaC Phase III (NCT03257033) trial seeks to compare intra-arterial gemcitabine against intravenous gemcitabine. Results from the sub-study detail how the use of the company’s TAMP system can increase the potency of gemcitabine, with the company saying that results suggest its system has the ability to lessen the impact of gemcitabine-related systemic side effects.
Side effects of gemcitabine include nausea, vomiting and other flu-like symptoms such as chills, fever, general feeling of illness, headache, muscle pain and weakness.
Speaking at the event, the principal investigator for the trial, Paula Novelli, said: “Pancreatic cancer remains one of the most challenging cancers to treat, and this new data further highlights the potential of RenovoRx’s TAMP therapy platform as a transformative therapeutic option.
“TAMP is intended to direct a drug and more effectively target the tumour while minimising systemic impact, and this sub-study shows that despite delivering more gemcitabine in a shorter time, the total systemic drug exposure was significantly lower compared to intravenous treatment.”
The TAMP system acts by using a drug-coated balloon to deliver chemotherapy through the layer of scar tissue via pressure-mediated delivery. The system in large part uses the company’s US Food and Drug Administration-cleared system, RenovoCath, for the intra-arterial administration of gemcitabine.
The TIGeR-PaC trial is a Phase III randomised multi-centre study that published its first interim analysis in 2023. Since then, the trial has quickly gained pace, adding new sites across the US and Europe. The study’s primary endpoint is an overall survival benefit with secondary endpoints including reduced side effects versus typically intravenously administered gemcitabine.
Elsewhere in the world of balloon-based delivery systems, Concept Medical has enrolled the first patient in its MAGICAL trial examining its sirolimus-coated balloon for patients living with below-the-knee peripheral artery disease.
