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RenovoRx Engages Oklahoma University (OU) Health as First Clinical Site in Preparation for the Pivotal Phase III CouGar Clinical Trial in Bile Duct Cancer

This study will be the Second Clinical Trial Evaluating RenovoGem™, a Combination Drug-Device Product, in a Difficult-to-Access Solid Tumor Cancer LOS ALTOS,

articleRenovorx, Inc.December 21, 20234/company/renovorx-inc/news/renovorx-engages-oklahoma-university-ou-health-as-first-clinical-site-in-preparation-for-the-pivotal-phase-iii-cougar-clinical-trial-in-bile-duct-cancer
RenovoRx Engages Oklahoma University (OU) Health as First Clinical Site in Preparation for the Pivotal Phase III CouGar Clinical Trial in Bile Duct Cancer

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[{"type":"text","content":"\nThis study will be the Second Clinical Trial Evaluating RenovoGem™, a Combination Drug-Device Product, in a Difficult-to-Access Solid Tumor Cancer\n\n\n LOS ALTOS, Calif.--(BUSINESS WIRE)--\nRenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today 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 (eCCA).\n\n\n“We are pleased to engage our first clinical site for our second pivotal clinical trial. The CouGar Trial marks an important milestone for RenovoRx as we expand our clinical pipeline for RenovoGem into bile duct cancer, a difficult-to-treat solid tumor cancer,” said Leesa Gentry, Senior Vice President of Clinical Operations at RenovoRx. “I’m extremely proud of our team and our collaborators for their tremendous work reinforcing our mission to improve patient lives by delivering innovative therapies that can potentially change the current paradigm of cancer care.”\n\n\nThe 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 (OU) Health is the first clinical site for the CouGar study.\n\n\n“Unfortunately, bile duct cancer today has a poor prognosis for patients. Despite early diagnosis, the five-year survival rate is approximately 24%,” said Paula Novelli, MD FSIR, CouGar National Principal Investigator, and Associate Professor of Radiology and Director of Interventional Radiology Research at the University of Pittsburgh Medical Center. “There are currently limited treatment options for patients diagnosed with this aggressive cancer, which only prolongs life by a few months. 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.”\n\n\nDr. David ...

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