With the number of newly diagnosed patients with pancreatic cancer rising and fewer than 20% suitable for surgery, improved treatment options for pancreatic cancer represents a critical health care need. Hence, Roger Williams Medical Center has accepted a role as investigational site for a Phase I clinical trial for a novel delivery technology that may enhance drug delivery capability into pancreatic cancers.
The study’s industry sponsor, biotech tech company TriSalus Life Sciences, a company focused on developing comprehensive solid tumor solutions, will work with Rogers Williams Medical Center on an innovative new treatment that combines its intravascular, tumor-directed proprietary Pressure-Enabled Drug Delivery (PEDD™) with standard of care systemic chemotherapy. The study sponsor TriSalus developed a new retrograde venous proprietary approach using the simpler pancreatic venous system, making it far more suitable for PEDD.
Traditional approaches for targeted therapeutic delivery to the pancreas rely on the use of the arterial system. The pancreatic arterial supply, however, poses unique anatomic challenges as the terminal pancreatic arteries are not large enough to accommodate delivery services. This constrains the ability for highly focused delivery of therapeutics to pancreatic tumors. The presence of highly dense tissue architecture and abnormal poor blood flow into solid tumors are critical barriers to drug delivery, resulting in less than 1 percent of systemic drug administration delivered into tumors with conventional therapies.
The PEDD™ -RVI Clinical Trial
The open-label trial will be conducted at Roger Williams Medical Center as a single-arm, dose-escalation Phase 1 study of patients with unresectable pancreatic adenocarcinoma. The trial will enroll 9 patients, and if dose-limiting toxicities (DLT) are not encountered, a total of 18 patients will be enrolled.
The goal of this clinical trial is to perform targeted delivery of the most toxic components of standard of care treatment regimen deep into pancreatic tumors using a novel approach that accesses the tumor via pancreatic veins. The chemotherapy involved is for the treatment of adults diagnosed with unresectable, pancreatic carcinoma. With the number of newly diagnosed patients with pancreatic cancer rising and fewer than 20% suitable for surgery, improved treatment options for pancreatic cancer are a critical health need.
This study is designed to assess the technical success and safety of administering oxaliplatin through retrograde venous infusion (RVI) followed by systemic administration of FOLFIRI, a regimen containing folinic acid, fluorouracil, and irinotecan. Secondary measures of the study include local progression free survival, systemic progression free survival, overall survival, radiographic response rates, serologic response rates, and neurotoxicity from oxaliplatin. Exploratory measures include correlation of infusion pressures with treatment response, in addition to serum oxaliplatin pharmacokinetics following PEDD™-RVI. Patients, who are new to treatment and have received first-line systemic therapy, are eligible for this trial
The Investigational Treatment
PEDD with SmartValve™ technology is a self-expanding, one-way micro-valve that enables optimal infusion pressures for deeper therapeutic penetration. Treatment is delivered directly into solid tumors with the goal to avoid healthy tissue while optimizing therapeutic effect. This pressurized delivery has the potential to open collapsed vessels in tumors and helps promote therapy delivery.
Research Site Comments
Steven C. Katz, MD, Director of the Office of Therapeutic Development at Roger Williams Medical Center, reports, “We hope this trial not only results in improved outcomes with standard of care chemotherapy treatments for pancreas cancer, but also enables use of this novel delivery platform for immuno-oncology agents in the future. Our focus on improving the therapeutic index for pancreas tumor treatments through regional delivery solutions designed to overcome high intra-tumoral pressures will hopefully have broad application and address critical unmet medical needs,”
About Roger Williams Medical Center
Located in Providence, R.I., Roger Williams Medical Center is a 220-bed acute care teaching hospital affiliated with Boston University Medical Center. It is host to the Roger Williams Cancer Center, a nationally recognized leader in cancer treatment and related research, as well as the state’s only Bone Marrow Transplantation Unit, and also offers clinical centers of excellence in digestive diseases, bariatric surgery and behavioral health. Roger Williams is an affiliate of Prospect Medical Holdings, Inc., a health and hospital system of 17 hospitals including a network of more than 162 outpatient facilities and clinics in Southern California, Connecticut, New Jersey, Pennsylvania and Rhode Island.
TriSalus Life Sciences
TriSalus Life Sciences is dedicated to improving patient outcomes in pancreatic and other highly intractable solid tumors. TriSalus™ Infusion Systems have the potential to deliver diagnostic, therapeutic agents, and immuno-stimulants directly into tumor vasculature powered by its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach with SmartValve™ technology to improve the distribution and penetration of therapy in solid tumors. This innovative approach has the potential to allow for the administration of multiple mechanisms that can work together to overcome inherent immune suppression within the solid tumor microenvironment.
Founded in 2011, they switched their name from Surefire Medical in 2018. They secured a $5 million convertible note in 2018.
Ritesh Rathore, MD at Roger Williams Medical Center