Interim Analysis of Data on Localized Delivery of Chemotherapy for Pancreatic Cancer

Illustration of pancreas

A scientific poster on the interim analysis of a dose-response/safety study of the intra-arterial delivery of chemotherapy using the RenovoCath was presented at this year’s 50th Annual Meeting of the Pancreas Club, one year after the safety study launched. Founded in 1966 in response to the lack of knowledge and study of the exocrine pancreas, the mission of the Pancreas Club is to promote the interchange of ideas between pancreatologists around the world. Each year, members from over twenty countries meet to present and discuss the latest research and developments in pancreatic medicine. The RenovoCath catheter isolates blood flow and enables the physician to deliver therapeutic agents into selected sites in the peripheral vascular system, potentially allowing for higher concentrations of therapeutic agents while reducing outflow and potential systemic side effects.

The study includes 20 patients (nine men and eleven women, with a median age of 70) with unresectable Stage 3 pancreatic cancer. In order to demonstrate the dose effect, the study participants were analyzed and divided into three groups with the intent to receive a four-stage dose escalation of gemcitabine up to 1000 mg/m2. The primary goal of the study is to assess the safety of delivering gemcitabine directly to pancreatic tumors via the peripheral vascular system.  Efficacy, while not the primary endpoint, is also being analyzed.

Enzyme markers, blood count, and constitutional endpoints are being monitored to assess for dose-limiting toxicities. The feasibility and the safety of repeated intra-arterial treatment sessions are also being assessed. Secondary endpoints of the study include tumor size (measured by imaging studies), tumor markers in the bloodstream, and the potential for a surgical option to remove the tumor.

Results indicate that the RenovoCath may safely deliver gemcitabine to the pancreas through the peripheral vascular system. Hematological markers indicate that the isolation of blood flow reduces systemic side effects of gemcitabine while allowing for a more concentrated dose of gemcitabine delivered locally. For patients who have received more than 4 grams of gemcitabine during the course of the study, researchers note a 62.5% reduction of CA 19-9 tumor markers and CT scans indicate tumor stability.

According to one of the study’s lead investigator, Dr. Alexander Rosemurgy, this delivery mechanism has the potential to be an effective treatment for locally advanced pancreatic cancer:

“We can give very, very high levels of chemotherapy … into the tumors and yet have body levels which are very, very acceptable to the patients. We think this will be another arrow in our quiver to treat pancreatic cancer and gives us yet another hope of prolonging survival,” said Dr. Rosemurgy.

The gemcitabine safety study is the first long-term study of RenovoCath. The study is ongoing and will monitor patients through continued gemcitabine treatments as well as resection procedures.

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