RenovoRx Enrolls First Patient at University of Nebraska for Phase III TIGeR-PaC Trial

RenovoRx, Inc., a clinical-stage biopharmaceutical company, has announced the enrollment of the first patient at the University of Nebraska Medical Center (UNMC) in its Phase III TIGeR-PaC clinical trial. This trial is investigating RenovoGem™, a drug-device combination designed for the treatment of Locally Advanced Pancreatic Cancer (LAPC). The TIGeR-PaC study employs RenovoRx’s TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform, aiming to deliver chemotherapy directly to the tumor site, potentially improving efficacy and reducing side effects compared to conventional systemic intravenous chemotherapy.

The Phase III trial is being conducted across multiple esteemed clinical sites in the United States. The University of Nebraska Medical Center joined the study in June 2024 and has now successfully enrolled its first patient. Dr. Kelsey Klute, an associate professor at UNMC specializing in gastrointestinal cancers, expressed optimism about the innovative intra-arterial approach of the TIGeR-PaC study. Dr. Klute highlighted the challenge of treating pancreatic cancer due to the thick layer of scar tissue surrounding the tumor, which often impedes effective drug delivery. The hope is that RenovoRx’s targeted therapy will penetrate this scar tissue, delivering higher concentrations of chemotherapy directly to the tumor and thereby improving patient outcomes and reducing adverse side effects.

The RenovoRx team shares this optimism. Leesa Gentry, Chief Clinical Officer of RenovoRx, praised the involvement of UNMC, noting that their participation will significantly contribute to the successful completion of the trial by next year. Gentry emphasized the importance of collaborating with leading medical centers like UNMC to enhance care for patients with challenging conditions such as pancreatic cancer.

The TIGeR-PaC trial targets patients diagnosed with unresectable LAPC, a condition typically associated with Stage 3 pancreatic cancer. This phase of the disease is characterized by the tumor’s advancement within the pancreas without extensive spread, making it inoperable. The trial's primary goal is to assess a six-month overall survival benefit, with secondary objectives including the reduction of side effects compared to traditional chemotherapy.

RenovoRx’s TAMP™ platform and its first product candidate, RenovoGem™, represent a novel approach to cancer treatment. RenovoGem combines gemcitabine, a chemotherapy drug, with the company’s proprietary RenovoCath® device, which facilitates the intra-arterial delivery of the drug. This method aims to precisely target the tumor, potentially enhancing the drug’s effectiveness while mitigating systemic toxicity.

The first interim analysis of the Phase III trial was completed in March 2023, with the Data Monitoring Committee endorsing the continuation of the study. A second interim analysis is slated to occur by late 2024, following the 52nd event in the trial.

Pancreatic cancer remains a formidable health challenge with a dismal five-year survival rate of 13% across all stages, according to the American Cancer Society. It is projected to become the second leading cause of cancer-related deaths by 2030. RenovoRx’s novel approach to delivering chemotherapy could represent a significant advancement in treating this aggressive disease.

RenovoRx continues to explore applications of its TAMP™ platform beyond pancreatic cancer, aiming to develop innovative, targeted oncology therapies to address unmet medical needs. The company’s commitment to transforming cancer care is reflected in its ongoing research and clinical trials, striving to enhance therapeutic outcomes while minimizing side effects for cancer patients.