We are Committed to Developing Transformative Therapeutic Applications for Improved Quality of Life, as well as Extended Life in Cancer Patients
While the oncology field has made progress with the treatment of cancers over the past few decades, the toxicity limitations of chemotherapy remain a barrier to effective standard of care treatment. The common objective in chemotherapy treatment innovation is to enhance dosing of the drug, while minimizing systemic toxicity. The standard of care for most cancers is systemic (intravenous) chemotherapy, which delivers chemotherapy throughout the body and as a result, often causes debilitating side effects.
RenovoRx’s lead product candidate, RenovoGem™ (gemcitabine, an FDA-approved chemotherapy, delivered via our patented delivery system) is regulated by the FDA as a novel oncology drug product. RenovoGem utilizes pressure-mediated delivery of gemcitabine across the arterial wall to bathe tumor tissue in chemotherapy. RenovoGem, via the RenovoTAMP® (RenovoRx Trans-Arterial Micro-Perfusion) therapy platform, is currently being evaluated in a Phase III clinical trial in Locally Advanced Pancreatic Cancer (LAPC). RenovoRx plans to evaluate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a Phase II trial beginning in the first half of 2023.
Indications
Pancreatic Cancer:
Pancreatic cancer is the second leading cause of cancer-related deaths with a 5-year combined overall survival rate of 11% (Stages I-IV).* Based on the results of Phase I/II clinical and observational registry studies, treatment with RenovoGem improved patient survival and reduced side effects for LAPC patients.
We have received Orphan Drug Designation for the treatment of pancreatic cancer, which would provide us with seven years of orphan exclusivity to market RenovoGem for our LAPC indication upon NDA approval, provided that we are the first sponsor to obtain FDA approval for intra-arterial gemcitabine for the LAPC indication.
Bile Duct Cancer (extrahepatic Cholangiocarcinoma [eCCA]):
RenovoRx plans to study RenovoGem in the Phase II/III CouGAr clinical trial evaluating its second application, bile duct cancer — a rare and aggressive cancer that forms in bile ducts. Bile ducts are thin tubes that carry a digestive fluid, called bile, from your liver to other digestive organs. eCCA starts in the bile ducts outside the liver. Most people with eCCA do not have symptoms until the disease becomes more advanced. For this reason, it is often difficult for clinicians to diagnose the disease early.
RenovoRx has received Orphan Drug Designation for Cholangiocarcinoma, which, if we are the first to obtain FDA approval for intra-arterial gemcitabine for the treatment of eCCA, could provide us with seven years of orphan exclusivity to market RenovoGem for the eCCA indication.
Lung Cancer, Uterine Tumors and Glioblastoma:
RenovoRx plans to launch preclinical studies to explore the application of RenovoGem for the treatment of other solid tumors such as locally advanced lung cancer, uterine tumors, and glioblastoma.