Financing Will Support Development of RenovoCath System to Treat Advanced Pancreatic Cancer

May 30, 2018—RenovoRx, Inc., which is developing a catheter-based approach to treating pancreatic cancer, announced a $10 million financing round of which the company closed $7 million in an initial tranche. The financing, led by Boston Scientific Corporation, will be used to support ongoing product development and clinical trials of RenovoRx's RenovoCath for the treatment of patients with locally advanced pancreatic cancer. The financing round also includes new investor, btov Partners, and existing investors Astia Angels; The Angels' Forum; The Halo Fund III, LP; Golden Seeds; and Acorn Campus Taiwan.

According to the company, the RenovoCath system is a drug-device combination designed to deliver chemotherapy directly to solid tumors. The dual-balloon infusion catheter reaches pancreatic tumors and delivers chemotherapy directly to the tumor inside the pancreas, without the need to identify blood vessels locally at the treatment site. An early feasibility study using this targeted approach suggested an improved survival benefit for patients with advanced pancreatic cancer compared with historical controls.

Based on early studies of patients with locally advanced pancreatic cancer and the potential to address a significant unmet need, the US Food and Drug Administration (FDA) recently granted RenovoCath an Orphan Drug Designation and approved an investigational new drug application for the company to advance directly to a pivotal phase 3 clinical study.

RenovoRx advised that enrollment has begun in a randomized, phase 3 study designed to compare intra-arterial chemotherapy via RenovoCath with systemic chemotherapy in approximately 300 patients with locally advanced pancreatic cancer at up to 20 sites across the United States. The primary endpoint is overall survival with secondary endpoints including safety and quality of life.

RenovoCath is indicated for the isolation of blood flow and delivery of fluids, including diagnostic, chemotherapeutic, and/or other therapeutic agents, to selected sites in the peripheral vasculature system. RenovoCath received FDA clearance in 2014, European CE Mark approval in 2015, FDA clearance for expanded labeling in 2017, and Orphan Drug Designation for the potential treatment of locally advanced pancreatic cancer in 2018.