TriSalus Life Sciences has enrolled the first patient in its Pressure-Enabled Regional Immuno-Oncology (PERIO™-02) trial evaluating SD-101, a toll-like receptor 9 (TLR9) agonist for adults with locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).

“Patients with advanced HCC or ICC often have limited options when seeking treatment, as checkpoint inhibitors have had some success in these indications but results are not what we want them to be in most cases,” said Steven C. Katz, MD, FACS, chief medical officer at TriSalus, said in a news release.

“The PERIO-02 clinical trial has potential to advance the scientific foundation required to help address this unmet need, deliver new therapies to improve clinical outcomes, and ultimately, give patients a better chance to respond more reliably to different forms of immunotherapy.”

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Up to 89 patients with uveal melanoma with liver metastases are being actively enrolled for this trial. The Pressure-Enabled Drug Delivery™ (PEDD) method will be used to administer SD-101 in conjunction with checkpoint inhibitors. The first trial site is the University of Texas MD Anderson Cancer Center, and more sites are anticipated.

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This trial is the second of 3 planned trials to assess TriSalus’ immunotherapy platform. The platform is particularly designed to address the challenges patients with liver tumors face, such as immune response suppression and high intratumoral pressure.

SD-101 reactivates the immune system inside the liver, and the delivery mechanism helps improve uptake of the medicine by modulating blood vessel pressure and flow. Efficacy will be measured based on the tumor response.

Early data on the safety of the platform have been encouraging, and SD-101 has demonstrated its capacity to reprogram the microenvironment of liver tumors in a positive manner for patients.


TriSalus Life Sciences enrolls first patient in PERIO-02 clinical trial, studying the delivery of SD-101 via pressure-enabled drug delivery in adults with hepatocellular carcinoma or intrahepatic cholangiocarcinoma. News release. TriSalus Life Sciences; May 10, 2022.