$RNXT RenovoRx Engages Oklahoma University (OU) Health as First Clinical Site in Preparation for the Pivotal Phase III CouGar Clinical Trial in Bile Duct Cancer
https://www.businesswire.com/news/home/20231221037143/en/
LOS ALTOS, Calif.--(BUSINESS WIRE)--RenovoRx, 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).
“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.”
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 (OU) Health is the first clinical site for the CouGar study.
“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.”
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.
“The current standard of care for bile duct cancer is systemic (intravenous) chemotherapy, which has poor uptake and delivery since there are few blood vessels feeding this type of tumor,” said Dr. Hassan Hatoum, Principal Investigator, Associate Professor and Hematologist and Oncologist at Oklahoma University Health Stephenson Cancer Center – Gastrointestinal Cancer Clinic. “RenovoRx’s clinical trial is evaluating targeted, trans-arterial 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.”
RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.
https://www.businesswire.com/news/home/20231221037143/en/
LOS ALTOS, Calif.--(BUSINESS WIRE)--RenovoRx, 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).
“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.”
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 (OU) Health is the first clinical site for the CouGar study.
“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.”
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.
“The current standard of care for bile duct cancer is systemic (intravenous) chemotherapy, which has poor uptake and delivery since there are few blood vessels feeding this type of tumor,” said Dr. Hassan Hatoum, Principal Investigator, Associate Professor and Hematologist and Oncologist at Oklahoma University Health Stephenson Cancer Center – Gastrointestinal Cancer Clinic. “RenovoRx’s clinical trial is evaluating targeted, trans-arterial 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.”
RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.
