TriSalus Life Sciences® Inc. with MedTech Acquisition Corporation announced that it has expanded the reach of its ongoing Pressure-Enabled Regional Immuno-Oncology⢠(âPERIOâ¢-01â and âPERIOâ¢-02â) clinical program. In recent months TriSalus has opened five new PERIOâ¢-01 (NCT04935229) clinical trial sites, at Stanford University Hospitals, University of California Los Angeles, University of Coloradoâs Anschutz Medical Campus, University of Washington Medical Center and University of Miamiâs Sylvester Comprehensive Cancer Center, in addition to five previously activated sites. The PERIOâ¢-01 trial is studying an investigational drug, SD-101, delivered intravascularly by the TriNav® Infusion System (âTriNav®â) using the companyâs proprietary Pressure-Enabled Drug Delivery⢠(âPEDDâ¢â) method of administration.
The study is evaluating whether this platform approach with SD-101 and PEDD⢠can improve the performance of systemic checkpoint inhibitors in treating patients with uveal melanoma with liver metastases. In addition to these U.S. sites, TriSalus anticipates opening future PERIOâ¢-01 clinical trial sites in the United Kingdom, Europe, and Canada. In parallel, TriSalus opened PERIOâ¢-02 (NCT05220722) trial sites at Columbia University and University of Colorado Denver, along with Rhode Island Hospital â which was announced last month as part of an expanded research collaboration with Lifespan Health System.
The PERIOâ¢-02 trial, expected to add additional sites in 2023, is evaluating whether this same platform approach with SD-101 and PEDD⢠can improve the performance of systemic checkpoint inhibitors in treating patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma. Both the PERIOâ¢-01 and PERIOâ¢-02 trials, which were initiated at The University of Texas MD Anderson Cancer Center as part of a multi-year strategic collaboration agreement, are studying the ability of SD-101 delivered by the PEDD⢠method of administration to overcome two major challenges in treating patients with liver and pancreatic tumors: immunosuppression and high intratumoral pressure. These two barriers can limit the delivery and efficacy of therapeutics, such as immunotherapy drugs, from reaching their targets and result in poor outcomes.