On August 11, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported completion of enrollment in the Company’s Phase III TIGeR-PaC trial in locally advanced pancreatic cancer (LAPC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of August 7, 2026, TIGeR-PaC trial investigators have been notified by RenovoRx that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial top line trial data is expected to be available during the second half of 2027.

This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating intra-arterial gemcitabine (IAG) via RenovoCath delivered through RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) platform as a novel drug-device product candidate for difficult-to-treat LAPC. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane).

Pancreatic cancer continues to represent a major unmet medical need, with limited treatment options and current standards of care centered largely on systemic chemotherapy, which can cause significant toxicity and related side effects for patients. TAMP is designed to deliver chemotherapy directly near the tumor site while potentially reducing systemic exposure.

"The TIGeR-PaC Phase III study represents an exciting step forward in the treatment of LAPC," said Hassan Hatoum, MD Associate Professor of Medicine Medical Director, GI Oncology Disease Site Chair, GI Oncology Disease Site Group Stephenson Cancer Center University of Oklahoma Health Sciences Center and principal investigator at the University of Oklahoma Health for the TIGeR-PaC trial. "For far too long, patients with LAPC have had limited options beyond systemic chemotherapy. This novel treatment approach offers hope by adding an innovative, locoregional and targeted intervention that has the potential to improve outcomes beyond the current standard of care. The preliminary results of this study have been encouraging and reinforce the importance of continuing to explore new strategies for this challenging disease."

Dr. Hatoum continued, "What makes this approach particularly promising is its adaptability. Because the FDA-approved RenovoCath device administers chemotherapy directly near the tumor, it can continue to be integrated with a systemic therapy protocol regardless of how standard systemic treatment evolves in the future, this provides a versatile platform that can remain relevant as new chemotherapy regimens and targeted therapies emerge."

"I am proud to be part of the Phase III trial evaluating IAG, working alongside an exceptional multidisciplinary team committed to advancing care for patients with LAPC. Together, we are developing innovative treatment strategies that have the potential to improve outcomes and quality of life for our patients. Beyond pancreatic cancer, this novel platform also offers hope for expanding targeted regional chemotherapy delivery to other cancers, potentially opening new therapeutic opportunities across multiple solid tumors," concluded Dr. Hatoum.

"Completing enrollment in the Phase III TIGeR-PaC trial marks a major milestone for RenovoRx," said Ramtin Agah, M.D., Executive Chairman, Chief Medical Officer, and Founder of RenovoRx. "TIGeR-PaC is the cornerstone of our clinical development program, and we are now closer than ever in our efforts to validate IAG and its efficacy through rigorous, long-term evaluation. We thank the participating clinical sites, the patients and their families for their dedication, support, and trust in this important study. With enrollment complete, we are now focused on advancing toward completion and data analysis. We believe TIGeR-PaC will provide meaningful additional validation of our TAMP therapy platform in an area with significant unmet need and limited therapeutic progress. The validation of this approach both in terms of tolerability and efficacy should provide additional tools for clinicians to offer patients in this challenging disease."

The study’s enrollment was supported by participation from nationally recognized cancer centers and academic medical institutions across the United States, including Johns Hopkins Medicine, University of Pittsburgh Medical Center, UT Southwestern Medical Center, University of Nebraska Medical Center, Baptist Health South Florida, Stephenson Cancer Center at the University of Oklahoma, and more.

The study has also progressed through two independent interim analyses triggered following the 26th event in 2023 and the 52nd event in 2025, with the study’s independent Data Monitoring Committee (DMC) recommending continuation of the trial on both occasions. Together, these accomplishments reflect the successful execution of RenovoRx’s lead clinical program and support continued evaluation of its proprietary TAMP therapy platform.

About RenovoCath
Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx’s first investigational drug-device combination product candidate, using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath device, is designed for the intra-arterial administration of chemotherapy, gemcitabine (IAG).

(Press release, Renovorx, AUG 11, 2026, View Source [SID1234669974])