TriSalus Life Sciences Technology Featured in Two Presentations at the Society of Interventional Radiology Annual Scientific Meeting
2024年3月26日 - 9:00PM
ビジネスワイヤ(英語)
– New safety and feasibility data from Phase
1/1b PERIO-03 trial for locally advanced pancreatic cancer supports
further development of the novel TriSalus Infusion System for
therapeutic delivery via retrograde venous delivery –
– A retrospective clinical study of the
Pressure-Enabled Drug Delivery™ (PEDD™) method supports selection
of the TriNav® Infusion System for treatment-refractory
hypovascular tumors –
Technology from TriSalus Life Sciences® Inc. (Nasdaq: TLSI), an
oncology company integrating its novel delivery technology with
immunotherapy to transform treatment for patients with liver and
pancreatic tumors, was featured in two oral presentations at the
Society of Interventional Radiology Annual Scientific Meeting.
PERIO-03 Phase 1/1b Update
TriSalus is studying an investigational class C toll-like
receptor-9 (TLR9) agonist, nelitolimod (formerly SD-101), delivered
intravascularly using the Company’s proprietary Pressure-Enabled
Drug Delivery™ (PEDD™) method of administration in three Phase 1
trials (periotrial.com). In PERIO-03, nelitolimod is delivered via
the PEDD method with the TriSalus Infusion System using a
retrograde venous approach, leveraging established interventional
radiology access techniques.
Early safety and feasibility data from the PERIO-03 trial for
locally advanced pancreatic adenocarcinoma showed technical success
in all five patients who had received eight treatment interventions
at data cutoff. There were no immediate complications from the
procedure, and there was no evidence of hemorrhage or thrombosis.
This follows a previous report indicating evidence of encouraging
immune signals such as decreases in myeloid derived suppressor
cells (MDSC) in the treated pancreatic tumors with evidence of
T-cell activation.
PEDD Performance in Hypovascular Solid Tumors
In a retrospective study, investigators from The University of
Texas MD Anderson Cancer Center reported on a variety of tumor
types, the majority of which were notable for being hypovascular
metastases and for which embolization may be clinically
challenging. Technical success for embolization using the TriNav
microcatheter was 100%. Tumors were treated in the liver (88%),
bone (9.4%), and adrenal gland (3.1%). Local tumor progression-free
survival rates across organs at one month, six months, and one year
were 94%, 80%, and 70%, respectively.
“The data presented at the Society of Interventional Radiology
meeting provide further evidence that the Pressure Enabled Drug
Delivery method has the potential to improve therapeutic uptake and
clinical outcomes at multiple disease sites, including the liver
and pancreas. The data, which suggest the PEDD method can address
solid tumor delivery challenges, align well with the 2024 outcomes
research study from Current Medical Research and Opinion, which
provides support for the recently awarded Centers for Medicare
& Medicaid Services reimbursement code for procedures involving
the TriNav system,” said Steven C. Katz, M.D., FACS, Chief Medical
Officer at TriSalus.
Both TriSalus presentations from SIR are available here.
About Pressure-Enabled Regional Immuno-Oncology
(PERIO) clinical trials The Pressure-Enabled
Regional Immuno-Oncology (PERIO) clinical trials are studying an
investigational class C toll-like receptor-9 agonist, nelitolimod,
delivered intravascularly by TriSalus’ TriNav® Infusion System
(TriNav) using the Company’s proprietary Pressure-Enabled Drug
Delivery™ (PEDD™) method of administration in three Phase 1
trials:
The PERIO-01 Phase 1 clinical study for uveal melanoma with
liver metastases (UMLM) is studying nelitolimod delivered via PEDD
with TriNav in combination with intravenous checkpoint
inhibitors.
The PERIO-02 Phase 1b clinical study for hepatocellular
carcinoma and intrahepatic cholangiocarcinoma, is studying
nelitolimod delivered via PEDD with TriNav in combination with
intravenous checkpoint inhibitors.
The PERIO-03 Phase 1 clinical study for locally advanced
pancreatic adenocarcinoma, is studying nelitolimod delivered via
PEDD with TriNav in combination with intravenous checkpoint
inhibitors.
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology company integrating novel
delivery technology with immunotherapy to transform treatment for
patients with liver and pancreatic tumors. The Company’s platform
includes devices that utilize a proprietary drug delivery
technology and a clinical stage investigational immunotherapy. The
Company’s two FDA-cleared devices use its proprietary
Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range
of therapeutics: the TriNav® Infusion System for hepatic arterial
infusion of liver tumors and the Pancreatic Retrograde Venous
Infusion System for pancreatic tumors. PEDD is a novel delivery
approach designed to address the anatomic limitations of arterial
infusion for the pancreas. The PEDD approach modulates pressure and
flow in a manner that delivers more therapeutic to the tumor and is
designed to reduce undesired delivery to normal tissue, bringing
the potential to improve patient outcomes. Nelitolimod, the
Company’s investigational immunotherapeutic candidate, is designed
to improve patient outcomes by treating the immunosuppressive
environment created by many tumors and that can make current
immunotherapies ineffective in the liver and pancreas. Patient data
generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO)
clinical trials support the hypothesis that nelitolimod delivered
via PEDD may have favorable immune effects within the liver and
systemically. The target for nelitolimod, TLR9, is expressed across
cancer types and the mechanical barriers addressed by PEDD are
commonly present as well. Nelitolimod delivered by PEDD will be
studied across several indications to address immune dysfunction
and overcome drug delivery barriers in the liver and pancreas.
In partnership with leading cancer centers across the country –
and by leveraging deep immuno-oncology expertise and inventive
technology development – TriSalus is committed to advancing
innovation that improves outcomes for patients. Learn more at
trisaluslifesci.com and follow us on Twitter and LinkedIn.
For Patients
To learn more about the clinical trial treatment protocol and
enrollment, visit http://www.periotrial.com or
http://www.clinicaltrials.gov and search NCT04935229, NCT05220722,
and NCT05607953.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240326745986/en/
For Media and Investor Inquiries: Argot Partners
212.600.1902 TriSalus@argotpartners.com
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