RenovoRx Updates Pivotal TIGeR-PaC Trial of Pancreatic Cancer Treatment

August 20, 2025—RenovoRx, Inc. announced an update of its ongoing pivotal phase 3 TIGeR-PaC trial, which is evaluating the company’s first investigational drug-device combination oncology product candidate, which uses RenovoRx’s TAMP transarterial microperfusion therapy platform enabled by its RenovoCath for the treatment of locally advanced pancreatic cancer.

The combination product candidate utilizes RenovoCath for the intra-arterial administration of the chemotherapy gemcitabine, noted RenovoRx.

The company stated that the current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events—deaths—necessary to complete the final analysis.

In the second quarter of 2025, the 52nd death triggered the second preplanned interim analysis to be reviewed by the independent data monitoring committee (DMC).

As noted in the press release, the DMC has concluded its review and has recommended that the company should continue the trial.

RenovoRx advised that after discussions with the DMC and consultation with its regulatory advisors, it has elected to defer publishing the TIGeR-PaC interim data to avoid compromising the integrity of the trial with the FDA. The company stated it will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal phase 3 trials.

The company also noted that during the second quarter, patient enrollment in TIGeR-PaC was initiated at Johns Hopkins Medicine in Baltimore, Maryland, which became the newest addition to the network of clinical cancer sites across the United States participating in the trial.

After the quarter, RenovoRx launched the PanTheR multicenter postmarketing registry study to follow patients undergoing cancer treatment delivered by its RenovoCath device to solid tumors. The observational registry is aimed at evaluating the long-term safety and effectiveness (survival) of targeted drug delivery of solid tumors via RenovoCath in real-world clinical settings.