RenovoRx is advancing its Trans-Arterial Micro-Perfusion (TAMP) therapy platform, designed for precise therapeutic delivery directly to tumors. This targeted approach aims to enhance efficacy while reducing the toxic side effects often associated with systemic intravenous (IV) therapies. The company's lead product candidate, currently in Phase III development, is a novel drug-device combination being investigated under a U.S. investigational new drug application regulated by the FDA.
The TAMP platform utilizes RenovoCath, an FDA-cleared device indicated for temporary vessel occlusion in procedures such as arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of gemcitabine via the RenovoCath device is currently under evaluation by the FDA's Center for Drug Evaluation and Research for the treatment of locally advanced pancreatic cancer (LAPC).
RenovoRx emphasizes that the TAMP platform's targeted delivery has the potential to improve both the safety and effectiveness of cancer treatments. By delivering the therapeutic agent directly to the tumor site, the platform aims to minimize exposure to healthy tissues, thereby reducing systemic toxicities. This approach could lead to better patient tolerance and improved clinical outcomes.
Beyond LAPC, RenovoRx is actively exploring other commercialization strategies for its TAMP technology and RenovoCath device as a standalone product. The company believes that the precision and versatility of the TAMP platform make it a promising tool for a range of targeted cancer therapies.