TriSalus Begins PERIO-02 Trial of SD-101 Via Pressure-Enabled Drug Delivery in Adults With HCC or ICC

May 10, 2022—TriSalus Life Sciences announced the enrollment of the first patient in its Pressure-Enabled Regional Immuno-Oncology (PERIO-02) clinical study.

According to the company, PERIO-02 is evaluating SD-101, which is an investigational toll-like receptor 9 agonist, in adults with locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), administered using the company’s pressure-enabled drug delivery (PEDD) method in combination with systemic checkpoint inhibitors.

The PERIO-02 clinical trial will first evaluate the safety of SD-101 delivered by PEDD in varying doses and with checkpoint inhibitors in patients with HCC or ICC. Efficacy will be evaluated based on the tumor response. The phase 1b/2 study will enroll up to 89 patients with HCC or ICC. Future studies will seek to validate this platform in additional liver and pancreatic tumor types.

The trial was initiated at The University of Texas MD Anderson Cancer Center in Houston, Texas, and additional sites are anticipated. The PERIO-02 trial’s Principal Investigator is Milind Javle, MD, Professor in the Department of Gastrointestinal Medical Oncology at MD Anderson Cancer Center.

The company noted that PERIO-02 is the second of three Pressure-Enabled Regional Immuno-Oncology studies planned across multiple indication and builds upon TriSalus’ collaboration with leading cancer research centers.

The initial trial using this platform, PERIO-01, is actively enrolling patients and is evaluating the safety of SD-101 administered by PEDD in combination with checkpoint inhibitors in patients with uveal melanoma with liver metastases. In September 2021, TriSalus Life Sciences announced that the first patient was enrolled in the PERIO-01 trial, which will enroll up to 52 patients in phase 1 and will be initiated at multiple cancer centers across the United States.

The PERIO-01 study has provided initial safety validation for the platform, and early data indicate the ability of SD-101 to favorably reprogram the tumor microenvironment of liver tumors, advised TriSalus.

The company’s website provides more information for SD-101, which aims to reactivate the immune system within the liver, and the PEDD method, which modulates pressure and flow within blood vessels to improve therapy uptake and tumor response.