RenovoRx, Inc. is making strides in the treatment of locally advanced pancreatic cancer (LAPC) with its ongoing Phase III TIGeR-PaC clinical trial. The trial assesses the efficacy of the company's Trans-Arterial Micro-Perfusion (TAMP) therapy platform, a novel approach designed to deliver targeted chemotherapy directly to the tumor while minimizing systemic side effects. Recent developments include the initiation of patient enrollment at SCRI Oncology Partners and the presentation of promising pharmacokinetic data at the ASCO Gastrointestinal Cancers Symposium 2025.
The TIGeR-PaC study is a randomized, multi-center trial comparing TAMP therapy, which involves intra-arterial infusion of gemcitabine via the RenovoCath delivery system, to the current standard-of-care systemic intravenous chemotherapy in patients with LAPC. The primary endpoint of the study is overall survival, with secondary endpoints including reduced side effects.
SCRI Oncology Partners Joins the TIGeR-PaC Trial
SCRI Oncology Partners in Nashville, TN, has become the latest clinical site to begin enrolling patients in the TIGeR-PaC trial. This collaboration is expected to accelerate patient enrollment and drive the study towards its anticipated completion in the first half of 2025. Meredith S. Pelster, M.D., MSCI, Associate Director for GI Research at SCRI, has been appointed as the principal investigator for the TIGeR-PaC study at SCRI Oncology Partners.
"Pancreatic cancer remains one of the most challenging cancers to treat. This important study potentially may offer patients new hope for improved survival and reduced systemic side effects," said Dr. Pelster.
SCRI's network includes more than 250 locations across 24 states in the U.S., reaching one in five patients with cancer annually. This extensive network is expected to significantly enhance patient recruitment for the TIGeR-PaC trial.
Promising Pharmacokinetic Data Presented at ASCO GI 2025
An abstract presentation at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) 2025 highlighted promising pharmacokinetic (PK) data from a sub-study of the TIGeR-PaC trial. The sub-study compared intra-arterial gemcitabine (IAG) delivery via TAMP to systemic intravenous gemcitabine, the current standard of care for LAPC.
The results indicated that the IAG approach decreased systemic levels of gemcitabine compared to the standard of care. This suggests that TAMP can increase local drug potency while potentially reducing gemcitabine-related systemic side effects.
"TAMP is intended to direct a drug and more effectively target the tumor while minimizing 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," said Paula Novelli MD, TIGeR-PaC Principal Investigator at University of Pittsburgh Medical Center.
TAMP Therapy Platform and RenovoCath Device
RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform is designed to deliver precise therapeutic doses across the arterial wall near the tumor site. The platform utilizes the company's FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy.
The RenovoCath device is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. It is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
Ongoing Phase III TIGeR-PaC Clinical Trial
The TIGeR-PaC trial is currently ongoing, with the second interim analysis expected to be triggered by the 52nd event (i.e., patient death), estimated to occur in early 2025. RenovoRx anticipates completing patient enrollment and the second interim analysis by the end of the first half of 2025.
Pancreatic cancer has a 5-year all stages combined relative survival rate of 13% and is projected to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond the pancreas but cannot be surgically removed, highlighting the urgent need for more effective and less toxic treatment options.
