Northwell Health Cancer Institute Launches Patient Enrollment in RenovoRx's Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial

Core Insights - RenovoRx, Inc. is advancing its Phase III TIGeR-PaC clinical trial for the treatment of Locally Advanced Pancreatic Cancer (LAPC) using its TAMP™ therapy platform, with Northwell Health Cancer Institute recently joining the study [1][3][6] - The TIGeR-PaC trial aims to evaluate the efficacy of TAMP in delivering gemcitabine directly to the tumor site, potentially improving treatment outcomes compared to standard systemic chemotherapy [2][6][10] - The study is expected to complete patient enrollment in the first half of 2025, with interim analyses ongoing to assess the treatment's effectiveness [8][7] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies, including the FDA-cleared RenovoCath® local drug-delivery platform [9][10] - The company's TAMP technology is designed to enhance the delivery of therapeutic agents directly to tumors while minimizing systemic side effects [9][11] - RenovoRx's lead product candidate is currently under investigation for its safety and efficacy in treating LAPC, with the potential for Orphan Drug Designation providing market exclusivity upon FDA approval [11][10] Clinical Trial Details - The TIGeR-PaC study is a randomized multi-center trial evaluating the TAMP therapy platform, specifically the intra-arterial infusion of gemcitabine [6][7] - The primary endpoint of the trial is to demonstrate an Overall Survival benefit, with secondary endpoints focusing on reduced side effects compared to standard care [7][8] - The first interim analysis was completed in March 2023, with recommendations to continue the study, and the second interim analysis is anticipated by late 2024 or early 2025 [7][8] Industry Context - Pancreatic cancer has a low 5-year survival rate of 13% across all stages and is projected to become the second leading cause of cancer-related deaths by 2030 [4] - LAPC is characterized by the inability to surgically remove the tumor, typically diagnosed at Stage 3 of the disease [4] - The innovative approach of TAMP therapy represents a significant advancement in the treatment landscape for pancreatic cancer, addressing a high unmet medical need [9][11]