RenovoRx said today that it closed a $7 million tranche in a $10 million round to fund the development of its drug-device combination product designed to deliver chemotherapy directly to tumors in patients with locally advanced pancreatic cancer.
The RenovoCath system is a dual-balloon infusion catheter that can deliver chemotherapy to a tumor inside the pancreas, according to RenovoRx, without the need to identify blood vessels near the treatment site.
The company touted results from a feasibility study showing that its approach yields an improved survival benefit for people with advanced pancreatic cancer compared to historical controls.
“There are significant challenges in treating pancreatic cancer and our aim is to overcome these barriers by using a catheter-based, targeted approach to delivering chemotherapy. This funding, along with our FDA orphan drug designation and approval of our IND are three important milestones in bringing this new therapy option to patients,” CEO Shaun Bagai said in prepared remarks.
The FDA has cleared the company to launch a pivotal Phase III trial of its technology and enrollment has already begun, RenovoRx reported. The 300-patient trial is slated to compare intra-arterial chemotherapy via RenovoCath to systemic chemotherapy. The primary endpoint is overall survival.
The RenovoCath device is already approved for the delivery of therapeutic agents to segments of the peripheral vasculature system. In March, RenovoRx won 510(k) clearance from the FDA to expand the product’s indication to include the delivery of chemotherapeutics.