TriSalus’ Infusion System With Nelitolimod to Treat Pancreatic Cancer Studied in PERIO-03 Trial

March 26, 2024—TriSalus Life Sciences Inc. announced that its technology was featured in two oral presentations. TriSalus is an oncology company integrating its delivery technology with immunotherapy for the treatment for patients with liver and pancreatic tumors.

According to the press release, TriSalus is studying an investigational class C toll-like receptor-9 (TLR9) agonist, nelitolimod (formerly SD-101), delivered intravascularly using the company’s pressure-enabled drug delivery (PEDD) method of administration in three phase 1 PERIO trials. The company’s website for the PERIO trials is periotrial.com.

In PERIO-03, nelitolimod is delivered via the PEDD method with the TriSalus infusion system using a retrograde venous approach, leveraging established interventional radiology access techniques.

The presentations were delivered at SIR 2024, the Society of Interventional Radiology’s annual scientific meeting held March 23-28 in Salt Lake City, Utah.

TriSalus reported that early safety and feasibility data from the phase 1/1b PERIO-03 trial for locally advanced pancreatic adenocarcinoma showed technical success in all five patients who had received eight treatment interventions at data cutoff.

There were no immediate complications from the procedure, and there was no evidence of hemorrhage or thrombosis. These findings come after a report indicating evidence of encouraging immune signals such as decreases in myeloid derived suppressor cells in the treated pancreatic tumors with evidence of T-cell activation.

Rahul A. Sheth, MD, who is Associate Professor at University of Texas MD Anderson Cancer Center in Houston, Texas, presented the findings at SIR 2024. The SIR abstract is available online here.

The second presentation at SIR presented data from a retrospective study of PEDD performance in a variety of tumor types, the majority of which were notable for being hypovascular metastases and for which embolization may be clinically challenging hypovascular solid tumors.

As summarized in the TriSalus press release, technical success for embolization using the company’s TriNav microcatheter was 100%. Tumors were treated in the liver (88%), bone (9.4%), and adrenal gland (3.1%). Local tumor progression-free survival rates across organs at 1 month, 6 months, and 1 year were 94%, 80%, and 70%, respectively.

The study was conducted by investigators from The University of Texas MD Anderson Cancer Center. Koustav Pal, MBBS, a Postdoctoral Research Fellow at MD Anderson delivered the findings at the meeting. The SIR 2024 abstract is available online here.

Steven C. Katz, MD, Chief Medical Officer at TriSalus, and a co-investigator of both studies, discussed the findings in the company’s press release.

“The data presented at the SIR meeting provide further evidence that the PEDD method has the potential to improve therapeutic uptake and clinical outcomes at multiple disease sites, including the liver and pancreas,” commented Dr. Katz. “The data, which suggest the PEDD method can address solid tumor delivery challenges, align well with the 2024 outcomes research study from Current Medical Research and Opinion, which provides support for the recently awarded Centers for Medicare & Medicaid Services reimbursement code for procedures involving the TriNav system.”