ENDOPROTECH, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant According to the CDC in ischemic heart disease is the leading cause of death worldwide and in the US approximately patients died of ischemic heart disease It is well established in clinical practice that recanalization of he infarct related artery IRA using percutaneous coronary intervention PCI enhances myocardial salvage and outcomes in patients with ST segment elevation myocardial infarction STEMI When the duration of ischemia exceeds h from onset of symptoms reperfusion injury following PCI often leads to infarct expansion due to the andquot no reflowandquot phenomenon in the microvasculature of the andquot area at riskandquot Multiple mechanisms are thought to contribute to andquot no reflowandquot and no effective treatment to ameliorate andquot no reflowandquot and infarct expansion during reperfusion has been identified in large randomized clinical trials following STEMI and PCI EndoProtech Inc has developed a novel therapeutic approach that alters the lipid content of endothelial cells ECs during PCI which has a stabilizing effect on the microvascular endothelium and ameliorates andquot no reflowandquot in the andquot area at riskandquot during reperfusion The overall goal of this project is to demonstrate the safety and efficacy of our lipotherapy in enhancing myocardial salvage following STEMI and PCI The aims of this Phase I proposal are Evaluate lipotherapy safety with preliminary screening tests for toxicity and Evaluate lipotherapy efficacy in a swine infarct model Successful completion of these aims will demonstrate that administration of our lipotherapy to the IRA during PCI just prior to reperfusion is safe reduces andquot no reflowandquot in the are at risk and enhances myocardial salvage During Phase II aims will be consistent with studies required by the FDA to ultimately provide the necessary data that will support a new drug application PUBLIC HEALTH RELEVANCE Percutaneous coronary intervention PCI to reopen blocked coronary arteries enhances myocardial salvage and outcomes but when blood flow is re established reperfusion it can lead to infarct expansion This infarct expansion is caused in part by the andquot no reflowandquot phenomenon that occurs in the microvasculature of the andquot area at riskandquot during reperfusion To reduce infarct expansion during reperfusion Endoprotech Inc has developed a lipid based treatment that protects the endothelium in the microvasculature from the andquot no reflowandquot phenomenon and enhances myocardial salvage following PCI