Northwell Health Cancer Institute (NHCI) has begun enrolling patients in RenovoRx's pivotal Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer (LAPC). This multi-center study is evaluating RenovoRx's TAMP (Trans-Arterial Micro-Perfusion) therapy platform, a novel approach to delivering targeted chemotherapy directly to the tumor site. The trial aims to improve efficacy and reduce systemic side effects compared to standard intravenous chemotherapy.
The TIGeR-PaC study utilizes RenovoRx’s FDA-cleared RenovoCath device to deliver gemcitabine intra-arterially. This method, known as TAMP, involves pressure-mediated delivery of the drug directly to the tumor. The study's primary endpoint is overall survival, with secondary endpoints including reduced side effects.
Rationale for TAMP Therapy
LAPC is a challenging disease with a poor prognosis. According to the American Cancer Society, the 5-year survival rate for pancreatic cancer is only 13%. LAPC is diagnosed when the cancer has not spread far beyond the pancreas but cannot be surgically removed. Current treatment options, primarily systemic intravenous chemotherapy, often result in significant side effects, limiting their effectiveness.
TAMP therapy offers a potential solution by delivering chemotherapy directly to the tumor, potentially increasing the drug's concentration at the site while minimizing systemic exposure. This targeted approach could improve patient outcomes and quality of life.
Study Design and Enrollment
The TIGeR-PaC trial is a randomized, multi-center study comparing TAMP therapy to standard-of-care intravenous chemotherapy in patients with LAPC. The first interim analysis, completed in March 2023, supported the continuation of the study. RenovoRx anticipates completing patient enrollment in the first half of 2025.
"We are pleased to be part of this pivotal study that holds the potential to transform the way we treat pancreatic cancer," said Dr. Daniel King, MD, PhD of Medical Oncology at NHCI. "TAMP represents a novel approach to targeted chemotherapy delivery near the tumor site, which may improve efficacy while reducing systemic side effects."
RenovoCath and Gemcitabine
RenovoCath is FDA-cleared for the isolation of blood flow and delivery of fluids, including diagnostic and therapeutic agents, to selected sites in the peripheral vascular system. In the TIGeR-PaC trial, it is used to deliver gemcitabine, a commonly used chemotherapy drug for pancreatic cancer, directly to the tumor.
RenovoRx has received Orphan Drug Designation for RenovoCath with gemcitabine for pancreatic cancer and bile duct cancer, granting 7 years of market exclusivity upon NDA approval by the FDA.
