TriSalus Life Sciences has enrolled the first subject in its Pressure-Enabled Regional Immuno-Oncology (PERIO-02) clinical trial of investigational therapy, SD-101, to treat adults with hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

A toll-like receptor 9 (TLR9) agonist, SD-101 will be given using the Pressure-Enabled Drug Delivery (PEDD) method along with systemic checkpoint inhibitors.

The trial was launched at The University of Texas MD Anderson Cancer Center in the US with further sites planned.

It will initially analyse the safety of various doses of SD-101 given by PEDD and along with checkpoint inhibitors in locally advanced, metastatic or unresectable HCC or ICC patients.

Furthermore, in PERIO-02, efficacy will be assessed depending on the tumour response.

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This is the second study in a series of trials to evaluate the company’s immunotherapy platform across various indications.

The platform merges investigational immunotherapy, SD-101, and drug delivery technology, PEDD, for addressing specific challenges of individuals with tumours in the liver.

SD-101 is intended for reactivating the immune system within the liver while PEDD is claimed to adjust pressure and flow within blood vessels to enhance uptake of the treatment and tumour response. 

This trial builds upon the company’s partnership with various cancer research centres to advance the development of its organ-specific platform and quickly deliver new therapies to patients. 

TriSalus Life Sciences chief medical officer Steven Katz said: “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.

“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.”