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RenovoRx Announces First Patient Enrolled at University of Nebraska Medical Center for the Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial
RNXTRenovoRx(RNXT) GlobeNewswire News Room·2024-08-14 12:30

Core Viewpoint - RenovoRx is advancing its Phase III clinical trial, TIGeR-PaC, for RenovoGem™ aimed at treating Locally Advanced Pancreatic Cancer (LAPC), with the first patient enrolled at the University of Nebraska Medical Center [1][3]. Company Overview - RenovoRx is a clinical-stage biopharmaceutical company focused on developing precision oncology therapies using a local drug delivery platform [8]. - The company’s lead product candidate, RenovoGem™, is a drug-device combination utilizing the FDA-cleared RenovoCath® device for intra-arterial chemotherapy delivery [5][8]. Clinical Trial Details - The TIGeR-PaC study employs the TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform to deliver gemcitabine directly to the tumor site, potentially overcoming barriers posed by scar tissue around pancreatic tumors [2][3]. - The trial is designed as a randomized multi-center study, with primary endpoints focused on 6-month Overall Survival benefits and secondary endpoints assessing reduced side effects compared to standard intravenous chemotherapy [6][5]. Enrollment and Collaboration - Enrollment for the TIGeR-PaC trial began in June 2024, with UNMC being the latest site to participate, expected to enhance patient recruitment due to its high volume of pancreatic cancer cases [1][4]. - The collaboration with UNMC aims to improve patient outcomes and advance the study towards completion [3][4]. Market Context - Pancreatic cancer is characterized by a low 5-year survival rate of 13% across all stages, with LAPC being particularly challenging as it is diagnosed when the cancer cannot be surgically removed [7]. - The ongoing research and development efforts by RenovoRx are positioned to address significant unmet medical needs in the treatment of LAPC [9].