Patient Reports Symptom Improvement in Phase III Trial of Experimental Targeted Chemotherapy for Pancreatic Cancer

An 83-year-old patient with locally advanced pancreatic cancer reported dramatic improvement in his daily life after switching from standard intravenous chemotherapy to a targeted delivery system in a Phase III clinical trial. Hernando Salcedo was diagnosed after presenting with a swollen stomach and hip pain.

He began standard chemotherapy and radiation in August 2015 and experienced severe side effects including nausea, exhaustion, inflamed stomach, persistent head pain, weight loss and almost no energy.

"My body was going through an incredible amount of stress," Hernando Salcedo said. " After enrolling in the trial at Miami Cancer Institute, Hernando Salcedo completed eight sessions of TAMP treatment, one every 15 days.

After switching to TAMP he stopped losing weight, regained appetite, improved color, gained energy and felt dramatically better. "The difference was tremendous," Hernando Salcedo said. " He was able to attend a family wedding and dance the entire night after TAMP treatment.

"That moment meant everything to me," he said. " RenovoRx is developing the Trans-Arterial Micro-Perfusion (TAMP) targeted drug-delivery system for chemotherapy. The RenovoRx platform uses the FDA-cleared RenovoCath device to deliver chemotherapy through a catheter placed in an artery near the tumor.

The RenovoCath catheter procedure is minimally invasive, performed in an outpatient setting without general anesthesia. A physician guides the catheter into position using X-ray imaging. Once in position, two small balloons on the catheter are inflated to isolate a targeted segment of artery adjacent to a tumor, after which the chemotherapy drug is infused between the balloons.

Dr. Ripal Gandhi, a vascular interventional radiologist and interventional oncologist at Baptist Health Miami Cardiac & Vascular Institute and Miami Cancer Institute, treated Hernando Salcedo.

Less than 10% of chemotherapy administered intravenously actually reaches tumor cells due to few blood vessels and dense fibrous stroma. "With IV chemotherapy, the drug travels through the bloodstream, affecting both cancerous and healthy cells, which can lead to side effects," Dr. Ripal Gandhi said.

The TIGeR-PaC trial is evaluating intra-arterial gemcitabine (IAG) delivered through RenovoCath for locally advanced pancreatic cancer. In the initial interim analysis of the TIGeR-PaC clinical trial, there was a trend towards improved overall survival by 6 months.

1 months with 65% fewer adverse events in the TAMP arm.

The RenovoCath catheter is already FDA-cleared for general therapy and chemotherapy delivery. Positive TIGeR-PaC trial data could support a new drug application to the FDA for intra-arterial gemcitabine (IAG). Enrollment in the Phase III TIGeR-PaC trial is expected to be completed in mid-2026.

Final results from the TIGeR-PaC trial are expected in 2027. "If positive, data generated from this trial could potentially support a new drug application for this combination product to the FDA for IAG," Shaun Bagai said. TAMP may be an option for patients who are not candidates for surgery, patients who have failed chemotherapy, or patients who no longer want to continue IV chemotherapy because of side effects.

TAMP can be used at any point within the treatment landscape, before, during or after other treatment modalities such as IV chemotherapy or radiation. The National Comprehensive Cancer Network recommends participation in a clinical trial whenever possible for pancreatic cancer patients. Dr.

Ripal Gandhi told Hernando Salcedo that he was an ideal candidate. The platform could apply to other solid tumors with limited blood supply, including bile duct cancer, certain lung cancers and sarcomas. The RenovoRx platform is designed to work with different types of therapies, not just one drug.

"The challenge we are addressing is not unique to pancreatic cancer," Shaun Bagai said.