On March 26, 2024 TriSalus Life Sciences Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported that its technology was featured in two oral presentations at the Society of Interventional Radiology Annual Scientific Meeting (Press release, TriSalus Life Sciences, MAR 26, 2024, View Source [SID1234641469]).
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PERIO-03 Phase 1/1b Update
TriSalus is studying an investigational class C toll-like receptor-9 (TLR9) agonist, nelitolimod (formerly SD-101), delivered intravascularly using the Company’s proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration in three Phase 1 trials (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.
Early safety and feasibility data from the 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. This follows a previous report indicating evidence of encouraging immune signals such as decreases in myeloid derived suppressor cells (MDSC) in the treated pancreatic tumors with evidence of T-cell activation.
PEDD Performance in Hypovascular Solid Tumors
In a retrospective study, investigators from The University of Texas MD Anderson Cancer Center reported on a variety of tumor types, the majority of which were notable for being hypovascular metastases and for which embolization may be clinically challenging. Technical success for embolization using the 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 one month, six months, and one year were 94%, 80%, and 70%, respectively.
"The data presented at the Society of Interventional Radiology meeting provide further evidence that the Pressure Enabled Drug Delivery method has the potential to improve therapeutic uptake and clinical outcomes at multiple disease sites, including the liver and pancreas. 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," said Steven C. Katz, M.D., FACS, Chief Medical Officer at TriSalus.
Both TriSalus presentations from SIR are available here.
About Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials The Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials are studying an investigational class C toll-like receptor-9 agonist, nelitolimod, delivered intravascularly by TriSalus’ TriNav Infusion System (TriNav) using the Company’s proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration in three Phase 1 trials:
The PERIO-01 Phase 1 clinical study for uveal melanoma with liver metastases (UMLM) is studying nelitolimod delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.
The PERIO-02 Phase 1b clinical study for hepatocellular carcinoma and intrahepatic cholangiocarcinoma, is studying nelitolimod delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.
The PERIO-03 Phase 1 clinical study for locally advanced pancreatic adenocarcinoma, is studying nelitolimod delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.