Kelsey Klute, MD, a medical oncologist at the Fred & Pamela Buffett Cancer Center and an associate professor in the UNMC Division of Oncology and Hematology Gastrointestinal Cancer, Pancreatic Cancer, is one of the investigators on a national trial to explore a new treatment for locally advanced pancreatic cancer.
Dr. Klute and her team are part of RenovoRx Inc.’s ongoing Phase III TIGeR-PaC clinical trial (IRB number 747-23-CB).
The TIGeR-PaC study is using RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform to evaluate the company’s RenovoGem investigational drug-device combination product. RenovoGem utilizes pressure-mediated delivery of chemotherapy across the arterial wall to bathe tumor tissue.
The study is comparing treatment with TAMP to the current standard-of-care through systemic intravenous chemotherapy.
Dr. Klute, who noted this year alone more than 66,000 Americans are expected to be diagnosed with pancreatic cancer, said chemotherapy given intravenously is the current standard treatment for most patients with pancreatic cancer. One of the biggest challenges in treating pancreatic cancer, she said, 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.
“This is one of the reasons we think 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 said.
The ongoing TIGeR-PaC study is evaluating RenovoRx’s innovative targeted (intra-arterial) approach to chemotherapy delivery, which in theory can deliver medicine through the layer of scar tissue directly to the tumor in the pancreas. RenovoRx’s first product candidate, RenovoGem, is a novel oncology drug-delivery combination utilizing TAMP administration technology combined with the FDA-approved chemotherapy gemcitabine.
“We are hopeful that this approach will lead to better outcomes for our patients: both improved survival as well as decreased side effects,” Dr. Klute said.
Leesa Gentry, chief clinical officer of RenovoRx, a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, said, “We are proud to partner with Dr. Klute and her team in our Phase III TIGeR-PaC trial. UNMC is renowned for its premier educational programs, innovative research and extraordinary patient care.
“We appreciate UNMC’s commitment to improving patient outcomes in pancreatic cancer through early detection and prevention education, multidisciplinary care and the development of novel therapeutic approaches like TAMP in collaboration with the sponsors.”
Shaun Bagai, CEO of RenovoRx said, “We are at an exciting juncture at RenovoRx, and, importantly, in our pivotal TIGeR-PaC trial. With the addition of top cancer centers, like UNMC, we accelerate towards our goal of completing patient enrollment next year. Moreover, the data we are collecting from the TIGeR-PaC study is invaluable to us as we continue to explore using TAMP in other cancer tumors, as well as other clinical and commercial business development opportunities for our novel drug-delivery technology.”