RenovoRx announced promising pharmacokinetic data from a sub-study of its ongoing Phase III TIGeR-PaC clinical trial, investigating its Trans-Arterial Micro-Perfusion (TAMP) therapy platform for locally advanced pancreatic cancer (LAPC). The sub-study compared intra-arterial gemcitabine (IAG) delivered via the RenovoCath system with the current standard of care, intravenous gemcitabine. Results indicate that IAG via TAMP reduces systemic gemcitabine levels, potentially increasing local drug potency and minimizing systemic side effects.
This data is crucial for advancing the treatment of LAPC, a notoriously difficult-to-treat cancer with limited effective options. The findings suggest that TAMP could offer a more targeted and potentially less toxic approach to chemotherapy delivery, directly addressing a significant clinical need. Improved local drug concentration could lead to better tumor control and potentially improved patient outcomes. Reducing systemic exposure holds the promise of lessening the debilitating side effects often associated with chemotherapy, thereby improving patients’ quality of life during treatment.
The sub-study, part of the larger TIGeR-PaC trial, analyzed pharmacokinetic data from a sample of trial participants. It directly compared IAG administered via RenovoCath and TAMP with intravenous gemcitabine. The data demonstrated a decrease in systemic gemcitabine levels with the IAG/TAMP approach, suggesting localized drug delivery. The primary endpoint of the main TIGeR-PaC trial is overall survival, with secondary endpoints focusing on reduced side effects compared to standard care. The first interim analysis, completed in March 2023, recommended continuing the study. The second interim analysis, triggered by the 52nd patient death, is anticipated in the first half of 2025. RenovoRx also aims to complete patient enrollment within the same timeframe.
This positive pharmacokinetic data strengthens the potential of RenovoRx’s TAMP platform as a viable treatment option for LAPC. Confirmation of these findings in the final analysis of the TIGeR-PaC trial could significantly impact the LAPC treatment landscape, offering a more targeted and potentially less toxic chemotherapy approach. It could also validate TAMP as a platform technology applicable to other cancer types. Pending successful trial completion and regulatory approval, RenovoRx’s approach holds promise for improved patient outcomes and quality of life in this challenging disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
