University of Nebraska Medical Center Begins Patient Enrollment for RenovoRx Phase III TIGeR-PaC Trial

Los Altos, California—RenovoRx, a clinical-stage biopharmaceutical company specializing in precision oncology therapies, has announced that the University of Nebraska Medical Center (UNMC) has begun enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in their ongoing Phase III TIGeR-PaC clinical trial. This pivotal study leverages RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform to evaluate its investigational drug-device combination, RenovoGem™.

The TIGeR-PaC study is a significant endeavor aiming to compare the effectiveness of TAMP with the current standard-of-care, which is systemic intravenous chemotherapy. RenovoGem utilizes pressure-mediated delivery of chemotherapy directly across the arterial wall to target tumor tissue, offering a potentially more effective method for drug delivery in pancreatic cancer treatment. This method addresses a critical challenge in treating pancreatic cancer: the dense scar tissue surrounding tumors that often hinders drug penetration.

Dr. Kelsey Klute, an Associate Professor at UNMC's Division of Oncology & Hematology, highlighted the importance of this study. According to Dr. Klute, over 66,000 Americans are expected to be diagnosed with pancreatic cancer this year alone. One of the key obstacles in treating this type of cancer is the difficulty in delivering drugs effectively to the tumor due to the thick scar tissue. The TIGeR-PaC study aims to circumvent this barrier by delivering chemotherapy directly to the tumor, which could lead to better patient outcomes, including increased survival rates and reduced side effects.

Leesa Gentry, Chief Clinical Officer of RenovoRx, expressed pride in partnering with Dr. Klute and her team for this trial. She praised UNMC for its outstanding educational programs, research innovation, and patient care. According to Gentry, UNMC’s commitment to early detection, prevention education, multidisciplinary care, and novel therapeutic approaches like TAMP aligns perfectly with the goals of the study.

Shaun Bagai, CEO of RenovoRx, emphasized the importance of this phase in the company’s development. He noted that adding top cancer centers like UNMC to the study accelerates the company’s goal to complete patient enrollment by next year. The data collected from the TIGeR-PaC study will also be invaluable as RenovoRx explores the use of TAMP in other cancer types and business development opportunities for their drug-delivery technology.

The Phase III TIGeR-PaC clinical trial is a multi-center study that is currently enrolling patients with unresectable LAPC across various esteemed cancer centers in the United States. The study’s primary endpoint is a 6-month overall survival benefit, with secondary endpoints including reduced side effects compared to the standard of care. The first interim analysis, completed in March 2023, recommended the continuation of the study, and the second interim analysis is expected to occur by late 2024.

Pancreatic cancer has a particularly low five-year survival rate of 13% across all stages, according to the American Cancer Society’s 2023 statistics. Locally Advanced Pancreatic Cancer (LAPC) is typically diagnosed when the disease has not spread extensively but is too advanced for surgical removal, often categorized as Stage 3.

RenovoRx is committed to transforming cancer treatment through innovative solutions. Their TAMP therapy platform is designed to deliver targeted treatment directly to tumors, potentially minimizing the toxicities associated with systemic therapies. Their leading product candidate, RenovoGem™, is currently being investigated for the treatment of LAPC.

RenovoRx continues to focus on developing precision oncology therapies that could revolutionize cancer treatment and improve patient outcomes.

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