RenovoRx Expands Enrollment in TIGeR-PaC Pivotal Trial

August 14, 2024—RenovoRx, Inc. announced an expansion of the ongoing phase 3 TIGeR-PaC randomized multicenter study evaluating the company’s transarterial microperfusion therapy (TAMP) platform for the treatment of locally advanced pancreatic cancer (LAPC).

The University of Nebraska Medical Center (UNMC) in Omaha, Nebraska, has joined the trial with its first patient enrolled in the trial. The TIGeR-PaC clinical trial is currently enrolling unresectable LAPC patients at several sites across the United States.

According to RenovoRx, RenovoGem (the company’s first product candidate using the TAMP technology) is an investigational oncology drug-delivery combination that uses the company’s FDA-cleared RenovoCath device for intra-arterial administration of gemcitabine chemotherapy.

RenovoGem uses pressure-mediated delivery of gemcitabine across the arterial wall near the tumor site to bathe the target tumor. The study compares treatment with TAMP in LAPC to the current standard of care (systemic intravenous chemotherapy).

Kelsey Klute, MD, Associate Professor at UNMC, Division of Oncology & Hematology Gastrointestinal Cancer, Pancreatic Cancer, discussed the trial in the company’s press release.

“Pancreatic cancer is aggressive and difficult to detect and treat,” commented Dr. Klute. “Chemotherapy given intravenously is the current standard treatment for most patients with pancreatic cancer.”

Dr. Klute continued, “One of the biggest challenges in treating pancreatic cancer is that the tumor cells build a thick layer of scar tissue around the tumor, and this scar tissue makes it difficult for drugs to penetrate the tumor itself. I think this is one of the reasons that many investigational drugs tested in pancreatic cancer fail—they simply aren’t reaching the tumor at high enough concentration to have an effect.”

Dr. Klute added, “The ongoing TIGeR-PaC study is evaluating RenovoRx’s innovative targeted (intra-arterial) approach to chemotherapy delivery, which aims to deliver medicine theoretically through the layer of scar tissue directly to the tumor in the pancreas. We are hopeful that this approach will lead to better outcomes for our patients: both improved survival as well as decreased side effects. With this initial enrollment since launching our participation in the study at UNMC just a little over a month ago, I am encouraged by the interest in this important study at UNMC.”