Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project, which is led by Ocean NanoTech in collaboration with Washington University, will complete development of a GLP-/GMP-ready 1- fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs.

Public Health Relevance

Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. While the emergent need for cardiac catheterization is self evident from the presentation of some individuals, the determination of whether to admit or discharge a patient with an equivocal history and physical is often problematic. In lieu of missing a critical cardiac diagnosis, patients are admitted for myocardial evaluation and stress testing, which is inconvenient, costly and unnecessary in the majority of cases. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project describes the demonstration of the prototype concept in Phase 1 and the development, demonstration, and characterization of the clinical product candidate in Phase II. The overarching goal of this project, which is led by Ocean NanoTech in collaboration with Washington University, will be to complete development of a GLP- /GMP-ready 1-fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
4R42HL112518-03
Application #
8712764
Study Section
Special Emphasis Panel (ZRG1-SBIB-T (10))
Program Officer
Danthi, Narasimhan
Project Start
2012-07-01
Project End
2016-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
3
Fiscal Year
2014
Total Cost
$500,010
Indirect Cost
Name
Ocean Nanotech, LLC
Department
Type
DUNS #
155516987
City
Springdale
State
AR
Country
United States
Zip Code
72764
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