Johns Hopkins Medicine has begun enrolling patients with locally advanced pancreatic cancer (LAPC) in RenovoRx's ongoing Phase III TIGeR-PaC clinical trial, marking a significant expansion of the trial's network of clinical sites across the United States.
The prestigious medical institution will conduct the trial at its Sibley Memorial Hospital campus, joining several other esteemed cancer centers participating in this study. This addition is expected to help RenovoRx achieve its goal of completing patient enrollment during 2025.
Key Leadership Appointments
Dr. Valerie Lee, Medical Oncologist at Johns Hopkins Medicine, has been appointed as the Principal Investigator for the TIGeR-PaC trial at the institution. Dr. Lee brings significant expertise in managing gastrointestinal malignancies, including pancreatic cancer, and oversees multiple early-phase clinical trials.
Dr. Michael J. Pishvaian, Director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs at Johns Hopkins Medicine, will continue in his role as Trial Chairman for the entire TIGeR-PaC trial, a position he has held since the trial's inception.
"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."
Trial Design and Current Status
The TIGeR-PaC trial is evaluating RenovoRx's innovative approach to treating LAPC using their proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform. The investigational treatment involves intra-arterial delivery of gemcitabine (IAG) via the FDA-cleared RenovoCath® device, comparing this targeted approach against the current standard-of-care systemic intravenous chemotherapy.
According to the current protocol, the trial requires 114 randomized patients, with 86 events (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, which RenovoRx anticipates will occur during the second quarter of 2025.
The Data Monitoring Committee's key recommendation on whether to continue the study based on the analyzed data is expected to be announced in the second half of 2025.
The Technology Behind the Trial
RenovoRx's TAMP therapy platform represents a novel approach to cancer treatment. The technology is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site, potentially minimizing toxicities compared to systemic intravenous therapy.
The RenovoCath device, which has already received FDA clearance, is intended for the isolation of blood flow and delivery of fluids, including diagnostic and therapeutic agents, to selected sites in the peripheral vascular system. It is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
While the RenovoCath device itself is FDA-cleared, the combination product candidate of intra-arterial gemcitabine delivered via RenovoCath is currently under investigation and has not been approved for commercial sale.
Potential Clinical Impact
Pancreatic cancer remains one of the most challenging malignancies to treat, with poor survival rates and limited effective treatment options, particularly for patients with locally advanced disease. The TIGeR-PaC trial aims to address this significant unmet medical need by evaluating whether targeted delivery of chemotherapy directly to the tumor site can improve outcomes.
"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," noted Gentry. "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."
Regulatory Status and Future Outlook
RenovoCath with gemcitabine has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon new drug application approval by the FDA.
Beyond the clinical trial, RenovoRx is also implementing commercialization strategies for its TAMP technology and FDA-cleared RenovoCath device as a stand-alone product. The company announced in December 2024 that it had received its first commercial purchase orders for RenovoCath devices, with some customers already initiating repeat orders.
As RenovoRx works to expand the number of medical institutions purchasing RenovoCath, including several National Cancer Institute-designated centers, the company continues to explore further revenue-generating activities either independently or in partnership with medical device commercial partners.
The addition of Johns Hopkins Medicine to the TIGeR-PaC trial represents an important step forward in RenovoRx's mission to transform the lives of cancer patients by providing innovative solutions for targeted delivery of therapeutic agents.
