Northwell Health Cancer Institute Begins Patient Enrollment for RenovoRx Phase III TIGeR-PaC Trial

RenovoRx, a life sciences company specializing in targeted oncology therapies, has announced the inclusion of the Northwell Health Cancer Institute (NHCI) in New York as a clinical site for its ongoing Phase III TIGeR-PaC clinical trial. This trial aims to evaluate the efficacy of RenovoRx's TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for treating locally advanced pancreatic cancer (LAPC).

Dr. Daniel King, a medical oncologist at NHCI, expressed optimism about the study's potential to revolutionize pancreatic cancer treatment. He highlighted that the TAMP approach could offer more effective chemotherapy delivery to tumor sites with reduced systemic side effects. This sentiment underscores NHCI's dedication to advancing cancer care and providing patients access to cutting-edge therapies.

The TIGeR-PaC study leverages RenovoRx’s TAMP therapy platform, which uses the FDA-cleared RenovoCath® delivery system to administer gemcitabine directly to tumors. This method contrasts with the traditional systemic intravenous chemotherapy by focusing on localized delivery, potentially enhancing the drug's efficacy and minimizing adverse effects.

Leesa Gentry, RenovoRx’s Chief Clinical Officer, praised NHCI as a highly regarded cancer center and a fitting partner for the trial. She emphasized that collaborating with New York's largest healthcare system could expedite patient enrollment and support the trial’s timely completion, anticipated for the first half of 2025.

LAPC is a severe form of pancreatic cancer characterized by its advancement to a stage where surgical removal is not feasible. It typically corresponds to Stage 3 of the disease, according to the TNM grading system. The American Cancer Society reports a 5-year relative survival rate of 13% for all stages of pancreatic cancer combined, underscoring the urgent need for improved treatment options.

RenovoRx’s RenovoCath® device, which has received FDA clearance, is designed for isolating blood flow and delivering diagnostic or therapeutic agents to specific sites in the peripheral vascular system. It is also used for temporary vessel occlusion during procedures like arteriography and chemotherapeutic drug infusion.

The TIGeR-PaC clinical trial is a randomized, multi-center study evaluating the TAMP platform for LAPC treatment. The first interim analysis in March 2023 led to a recommendation to continue the study. The trial aims to demonstrate an overall survival benefit, with secondary endpoints including reduced side effects compared to the current standard of care. The second interim analysis is expected by late 2024 or early 2025, contingent on patient events.

RenovoRx’s mission is to transform cancer treatment by providing innovative solutions for targeted drug delivery. The company’s leading product candidate, an investigational oncology drug-device combination, uses the RenovoCath® device for intra-arterial chemotherapy infusion. This approach is currently under evaluation for LAPC treatment by the FDA’s Center for Drug Evaluation and Research.

RenovoRx is also exploring various commercialization strategies for its TAMP technology and RenovoCath delivery system. The intra-arterial infusion of gemcitabine via RenovoCath has not yet received approval for commercial sale, but it has been granted Orphan Drug Designation for pancreatic and bile duct cancer, offering seven years of market exclusivity upon FDA approval.

As RenovoRx continues to develop its targeted oncology therapies, it remains committed to enhancing safety, tolerance, and efficacy for cancer patients through innovative drug delivery solutions.