RenovoRx TAMP System Targets Pancreatic Cancer Chemo in Phase III Trial

Standard chemotherapy saves lives but brings harsh side effects like nausea, exhaustion and infections because it travels through the bloodstream and harms healthy cells. RenovoRx's targeted drug-delivery system aims to change that for some pancreatic cancer patients.

The system, Trans-Arterial Micro-Perfusion or TAMP, sends chemotherapy directly near the tumor. It is under study in a Phase III clinical trial for locally advanced pancreatic cancer. The FDA-cleared RenovoCath device delivers the drug through a catheter placed in an artery near the tumor. A physician uses X-ray imaging to guide it into position.

Shaun Bagai, CEO of RenovoRx, said the platform localizes delivery near the tumor. "Once in position, two small balloons on the catheter are inflated, and the system is adjusted to isolate a targeted segment of artery adjacent to a tumor," Bagai said. "The chemotherapy drug is then infused between the balloons, creating pressure to push the drug across the vessel wall and near the tumor, directly bathing the target tumor."

The procedure is minimally invasive and done outpatient without general anesthesia. Dr. Ripal Gandhi, a vascular interventional radiologist and interventional oncologist at Baptist Health Miami Cardiac & Vascular Institute and Miami Cancer Institute, said standard IV chemotherapy affects healthy cells. "With IV chemotherapy, the drug travels through the bloodstream, affecting both cancerous and healthy cells, which can lead to side effects," Dr. Gandhi said.

Pancreatic cancer is tough to treat because tumors block drug access. "Studies have shown that less than 10% of chemotherapy administered intravenously actually reaches tumor cells due to the few blood vessels in the tumor as well as dense fibrous stroma, which serves as a physical barrier in the tumor microenvironment," Dr. Gandhi said. TAMP delivers drugs directly near the tumor without relying on bloodstream circulation.

Hernando Salcedo, 83, enrolled in the trial at Miami Cancer Institute after standard chemotherapy left him weak and nauseous. Diagnosed with locally advanced pancreatic cancer in August 2015 after stomach swelling and hip pain, he endured stress, inflamed stomach, headaches and no energy while getting chemo and radiation. "My body was going through an incredible amount of stress," Hernando said. "It was a very difficult period, both physically and emotionally."

After eight TAMP sessions every 15 days, he improved. "The difference was tremendous," Hernando said. "I completed eight sessions, one every 15 days, and I felt dramatically better than I did with the original chemotherapy." He regained appetite, energy and weight. He attended a family wedding and danced all night. "That moment meant everything to me," he said. "After everything I had been through, being able to celebrate with my family in that way felt like a gift."

Early data from the Phase III TIGeR-PaC trial show a trend toward six months better overall survival, 8.1 months better progression-free survival and 65% fewer adverse events with TAMP. Completed studies indicated better outcomes and fewer side effects. Enrollment ends mid-2026, with results in 2027. Positive data could support a new drug application for intra-arterial gemcitabine.

Dr. Gandhi said Hernando fit well: his tumor was too advanced for surgery but had not spread. The National Comprehensive Cancer Network recommends clinical trials when possible. TAMP suits non-surgical patients, those who failed chemo or cannot tolerate IV due to side effects. It works before, during or after other treatments.

RenovoRx sees uses for other solid tumors with poor blood supply like bile duct cancer, some lung cancers and sarcomas. "The platform is designed to work with different types of therapies, not just one drug," Bagai said.