RenovoRx Prepares for CouGar Pivotal Trial of RenovoGem in Bile Duct Cancer

December 27, 2023—RenovoRx, Inc. recently announced key developments in the pivotal phase 3 CouGar trial that will evaluate the company’s RenovoGem in bile duct cancer.

The randomized CouGar study is designed to evaluate the safety and efficacy of unresectable, locally advanced extrahepatic cholangiocarcinoma using intravenous (IV) cisplatin, gemcitabine, and durvalumab versus transarterial microperfusion (TAMP) via the RenovoGem delivery system and gemcitabine with intravenous durvalumab.

According to the company, Oklahoma University Health in Oklahoma City, Oklahoma, was engaged as the first clinical site for the CouGar study. Hassan Hatoum, MD, who serves as a principal investigator in CouGar, is Associate Professor and hematologist and oncologist at Oklahoma University Health’s Stephenson Cancer Center—Gastrointestinal Cancer Clinic.

“The current standard of care for bile duct cancer is systemic IV chemotherapy, which has poor uptake and delivery since there are few blood vessels feeding this type of tumor,” commented Dr. Hatoum in the company’s press release. “RenovoRx’s clinical trial is evaluating targeted, transarterial delivery of chemotherapy that is locally directed to the tumor site. Our team looks forward to participating in the CouGar study to bring this novel therapy to patients.”

The CouGar National Principal Investigator is Paula Novelli, MD. Dr. Novelli is Associate Professor of Radiology and Director of Interventional Radiology Research at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania. David Geller, MD, who is Director, UPMC Liver Cancer Center, Richard L. Simmons Professor of Surgery, at the University of Pittsburgh School of Medicine is coinvestigator of the trial.

“Unfortunately, bile duct cancer today has a poor prognosis for patients,” commented Dr. Novelli in the RenovoRx’s press release. “Despite early diagnosis, the 5-year survival rate is approximately 24%. There are currently limited treatment options for patients diagnosed with this aggressive cancer, which only prolongs life by a few months.”

Dr. Novelli added, “The CouGar study brings hope for a new treatment option. RenovoGem has the potential to meet the urgent clinical need for a safe and effective therapy in this important patient population.”

RenovoRx stated that its TAMP therapy platform is designed to provide precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic IV therapy. RenovoGem, an oncology drug-device combination product, is being investigated under a US investigational new drug designation that is regulated by an FDA 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer by the FDA’s Center for Drug Evaluation and Research.

RenovoGem received FDA Orphan Drug designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon the new drug application approval. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale, advised the company.