RenovoRx, Inc. announced the expansion of their clinical development pipeline in preparation for the commencement of a second Phase III trial. The CouGar Trial will evaluate RenovoGem in bile duct cancer, specifically unresectable locally advanced extrahepatic cholangiocarcinoma. The pivotal Phase III CouGar study is a randomized study designed to evaluate the safety and efficacy of unresectable, locally advanced eCCA using intravenous cisplatin, gemcitabine, and durvalumab (all forms of chemotherapy) versus Trans-Arterial Micro-Perfusion via RenovoGem (delivery system and gemcitabine) with intravenous durvalumab.

Oklahoma University Health is the first clinical site for the CouGar study. Dr. David Geller, Director, UPMC Liver Cancer Center, Richard L. Simmons Professor of Surgery, University of Pittsburgh School of Medicine is the CouGar study?s Co-Investigator. RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.