Clinical-stage biopharmaceutical company RenovoRx has selected Oklahoma University (OU) Health as its first study centre for the Phase III CouGar Trial of RenovoGem to treat bile duct cancer.
RenovoGem will be analysed in bile duct cancer, specially to treat unresectable locally advanced extrahepatic cholangiocarcinoma (eCCA).
The pivotal, randomised trial is designed to assess the efficacy and safety of trans-arterial micro-perfusion (TAMP) using the RenovoGem delivery system and gemcitabine with intravenous durvalumab to treat unresectable, locally advanced eCCA.
This treatment will be compared with all types of chemotherapy including intravenous cisplatin, gemcitabine and durvalumab.
UPMC Liver Cancer Center director Dr David Geller and University of Pittsburgh School of Medicine surgery professor Richard Simmons will serve as the co-investigators of the trial.
The FDA has granted orphan drug designation for RenovoGem in treating pancreatic cancer and bile duct cancer.
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This designation allows seven years of market exclusivity for the product subject to approval from the regulator for new drug application (NDA).
RenovoRx Clinical Operations senior vice-president Leesa Gentry said: “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 tumour cancer.
“I am 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.”
A lead product candidate of the company, RenovoGem is an oncology drug-device combination product.
It is also being analysed to treat locally advanced pancreatic cancer by the FDA’s Center for Drug Evaluation and Research.
RenovoRx focuses on the development of targeted combination treatment for areas with high unmet medical needs to boost outcomes in cancer patients who are receiving treatment.
The company’s TAMP therapy platform aids in accurately delivering the therapeutic to act on the tumour while cutting down toxicities associated with the therapy as against systemic intravenous treatments.