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RenovoRx Achieves Major Milestone with Full Enrollment in Phase III TIGeR-PaC Trial for Locally Advanced Pancreatic Cancer

RNXT
  • RenovoRx, Inc. announced the completion of patient enrollment in its Phase III TIGeR-PaC trial for locally advanced pancreatic cancer (LAPC) as of August 7, 2026.
  • The trial aims to observe 86 patient deaths (events) for completion, with 78 events recorded as of August 11, 2026.
  • Trial completion is expected during the first half of 2027, with initial top-line data anticipated in the second half of 2027.
  • The study evaluates intra-arterial gemcitabine (IAG) delivered via the RenovoCath device using the Trans-Arterial Micro-Perfusion (TAMP™) platform against standard systemic chemotherapy.
  • The primary endpoint of the trial is overall survival, with secondary goals to assess safety and tolerability.
  • Independent Data Monitoring Committees recommended trial continuation during interim analyses following the 26th event in 2023 and the 52nd event in 2025.
  • Enrollment was supported by multiple U.S. medical institutions, including Johns Hopkins Medicine, University of Pittsburgh Medical Center, UT Southwestern Medical Center, University of Nebraska Medical Center, Baptist Health South Florida, and Stephenson Cancer Center.
  • RenovoRx generated approximately $1.1 million in RenovoCath sales in 2025 and $563,000 in the first quarter of 2026.
  • The IAG combination product has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, granting seven years of market exclusivity upon FDA approval.
  • The trial is currently regulated under a U.S. investigational new drug application by the Center for Drug Evaluation and Research.