On May 19, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that it will present preclinical research supporting its planned second clinical indication, bile duct cancer, also known as cholangiocarcinoma, at the Global Embolization Oncology Symposium Technologies (GEST) 2022, in New York City (Press release, Renovorx, MAY 19, 2022, View Source [SID1234614885]). The study demonstrates the potential utility of RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform for the treatment of cholangiocarcinoma.

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Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts — thin tubes that carry a digestive fluid, called bile, from the liver to other digestive organs. Most people with cholangiocarcinoma do not have symptoms until the disease becomes more advanced, making early diagnoses difficult. Like pancreatic cancer, which the Company is evaluating in a Phase 3 study, bile duct tumors that grow outside of the liver lack tumor feeder blood vessels, which provide a pathway between the blood stream and the tumor. Tumor feeders are critical to the effectiveness of systemic chemotherapy. Published research supports that without direct access to the tumor, systemic chemotherapy circulates through the body, without a significant amount of chemotherapy reaching the tumor.

RenovoRx plans to launch a Phase 2/3 study in cholangiocarcinoma in the second half of 2022. The Company also received Orphan Drug Designation for this clinical indication in April 2021.

"We are pleased to present our preclinical research data studying RenovoTAMP’s utility in cholangiocarcinoma at this peer-reviewed, scientific meeting – GEST 2022," said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder at RenovoRx. "To be effective, chemotherapy must be able to reach the tumor. RenovoTAMP was designed to bring the chemotherapy to the tumor when there is no other pathway available. Through localized delivery of chemotherapy, we are hoping to provide a more effective treatment option for cancer patients, reduce the debilitating side effects typical of standard of care systemic chemotherapy and improve patient survival for cancers like cholangiocarcinoma."

The purpose of the preclinical study was to compare the effectiveness of delivery of a chemotherapeutic agent inside the bile duct via the gall bladder versus intra-arterially, into the tissue surrounding the bile duct (RenovoTAMP). This study determined that delivery via the gallbladder resulted in zero tissue penetration. In comparison, intra-arterial delivery resulted in extensive tissue penetration, confirming the Company’s plan to utilize RenovoTAMP in its planned Phase 2 study.

The abstract and poster for the study, "Localized Delivery of Chemotherapy Through the Bile Duct Using a Double Balloon Catheter in A Porcine Model," are available on RenovoRx’s website: View Source

RenovoTAMP is currently being investigated in the Phase 3 TIGeR-PaC clinical trial as a potential treatment option for patients with unresectable locally advanced pancreatic cancer. RenovoRx received Orphan Drug Designation for pancreatic cancer in 2018.