PDAC is the most common tumor arising in the pancreas, accounting for about 85-90% of cases.1 Diagnosis often occurs late, and more than half of patients with pancreatic cancer will have liver metastases at the time of diagnosis.2 Pancreatic liver metastases are associated with poor prognosis, with the median survival time reported to be less than 6 months.3
TriSalus’ PDAC with liver metastases clinical program will initially evaluate our investigational TLR9 agonist, SD-101, delivered deep into the vasculature of the liver tumors using our proprietary, FDA cleared device. Traditionally, TLR9 agonists like SD-101 are not administered intravenously but by direct injection into superficial tumors, making treatment of liver metastases very difficult.
TriSalus’ approach will study the delivery of SD-101 directly into the arteries supplying the liver in order to distribute the drug to PDAC liver metastases within the organ, irrespective of size, number and location of tumors. Infusion by the TriSalus device using the Pressure-Enabled Drug Delivery™(PEDD™) method improves targeted delivery of therapy into high-pressure tumors using a standard intraarterial procedure.
Because immune cells are suppressed throughout the liver and micro-metastases or undetectable additional tumors may be present, tissue that appears normal is also treated with SD-101. Importantly, the SD-101 treatment is being given in combination with a systemic (or intravenous) immunotherapy to enable treatment of tumors within the liver as well as tumors that may be present in other parts of the body.
SD-101 is in clinical development and has not been approved in the US or globally.
We are studying the combination of SD-101 with PEDD to enable immunotherapies in the liver and pancreas. Our clinical research is focused on bringing this potentially transformative treatment platform to patients.
1. Kim SS, et al. J Belg Soc Radiol. 2018; 102(1):71.
2. Ouyang H, et al. Pancreas. 2011;40(1):120-125.
3. Jemal A, et al. CA Cancer J Clin. 2008;58(2):71-96.
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