First patient enrolled in PERIO-02 trial of SD-101 delivery via pressure-enabled drug delivery for hepatocellular carcinoma or intrahepatic cholangiocarcinoma


trisalusTriSalus Life Sciences announced the enrolment of the first patient in its Pressure-Enabled Regional Immuno-Oncology (PERIO-02) clinical study in a press release. 

The trial is evaluating SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in adults with locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). SD-101 will be administered using the Pressure-Enabled Drug Delivery (PEDD) method in combination with systemic checkpoint inhibitors.

Initiated at The University of Texas MD Anderson Cancer Center (Houston, USA) with additional sites anticipated, the study is the second in a series of clinical trials assessing TriSalus’ immunotherapy platform across multiple indications.

The initial trial using this platform, the PERIO-01 study, is actively enrolling and is evaluating the safety of SD-101 administered by PEDD in combination with checkpoint inhibitors in patients with uveal melanoma with liver metastases.

“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, chief medical officer at TriSalus. “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.”

While immunotherapy has yielded significant advances in cancer treatment, unique properties of liver tumours, including immune response suppression and high intratumoral pressure, can prevent optimal delivery and performance of therapeutics and limit the overall effectiveness of immunotherapy for patients with liver cancers.

“With the PERIO-02 trial, we are striving to enable immunotherapy for the most common primary liver tumours,” said Katz. “The study is implementing a multifaceted approach by testing the integration of an immunotherapeutic, SD-101, with a [US Food and Drug Administration]-cleared delivery device, to hopefully induce the type of immune response that we are so eager to see for patients with HCC and ICC.”


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