On April 29, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that Johns Hopkins Medicine is now initiated to enroll patients with locally advanced pancreatic cancer (LAPC) in RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial (Press release, Renovorx, APR 29, 2025, View Source [SID1234652338]). Johns Hopkins Medicine becomes the newest addition to a distinguished network of clinical cancer sites across the United States participating in this important trial.
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The initiation of patient enrollment at Johns Hopkins Medicine will be at their Sibley Memorial Hospital campus and marks the most recent site to support RenovoRx’s path to completing patient enrollment for the trial. RenovoRx is expecting to achieve full enrollment in the TIGeR-PaC trial during 2025.
In addition, RenovoRx announced that John Hopkins Medicine’s Valerie Lee, MD, Medical Oncologist, has been appointed as TIGeR-PaC Principal Investigator (PI) at Johns Hopkins Medicine. Michael J. Pishvaian, MD, PhD, Director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs at John Hopkins Medicine, currently serves as Trial Chairman for the entire TIGeR-PaC trial.
The TIGeR-PaC trial is evaluating RenovoRx’s lead drug-device combination product candidate, intra-arterial delivery of gemcitabine (IAG) via the FDA-cleared RenovoCath device, which uses RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for the treatment of LAPC. This drug-device combination product candidate is currently under FDA investigation and has not been approved for commercial sale. The trial is comparing treatment with IAG in LAPC to the current standard-of-care (systemic intravenous chemotherapy).
"We are pleased that Johns Hopkins Medicine has been initiated to begin enrollment in our ongoing Phase III TIGeR-PaC clinical trial," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "The addition of this prestigious cancer center further strengthens our trial. The philosophy of Johns Hopkins Medicine’s leading researchers and clinicians aligns strongly with our vision of providing specialized medicine that translates into personalized care for improved patient outcomes. Dr. Michael Pishvaian, who has served as our TIGeR-PaC Trial Chair since the trial’s inception, will continue to provide deep understanding of the pancreatic cancer landscape. With the addition of Johns Hopkins Medicine as a clinical trial site, Dr. Valerie Lee will join the trial serving as Principal Investigator. This new clinical site will help drive enrollment of the TIGeR-PaC trial to completion as they treat a large number of patients diagnosed with pancreatic cancer. We are proud to partner with Johns Hopkins Medicine as well as our other TIGeR-PaC clinical sites as they strive to provide the best in care for patients diagnosed with difficult-to-treat tumors like pancreatic cancer."
At Johns Hopkins Medicine, Dr. Lee’s expertise includes management of gastrointestinal malignancies, including gastric, colon, and pancreatobiliary cancers. She also oversees multiple early-phase clinical trials, with her research being published in numerous peer-reviewed journals.
Johns Hopkins Medicine’s Sibley Memorial Hospital campus ranks among the top hospitals in the Washington, D.C., metropolitan area, delivering comprehensive healthcare services to local communities. The hospital provides an extensive array of care, including medical, surgical, intensive care, obstetric, oncology, and orthopedic services, alongside numerous inpatient and outpatient offerings.
The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (i.e., patient deaths) necessary to complete the final analysis. As of March 28, 2025, 90 patients have been randomized with 50 events having occurred. A second interim analysis will be triggered by the 52nd event. The timing required to analyze the data after the 52nd event is expected to take several months and includes a full review with recommendations by the TIGeR-PaC Data Monitoring Committee. RenovoRx currently anticipates the 52nd event to occur during the second quarter of 2025. The key recommendation from the Data Monitoring Committee on whether or not to continue the study based on the data reviewed is expected to be announced in the second half of 2025.