SBIR/STTR Award attributes
According to the CDC inischemic heart disease is the leading cause of death worldwideand in the US approximatelypatients died of ischemic heart diseaseIt is well established in clinical practice that recanalization of the infarct related arteryIRAusing percutaneous coronary interventionPCIenhances myocardial salvage and outcomes in patients with ST segment elevation myocardial infarctionSTEMIWhen the duration of ischemia exceedsh from onset of symptomsreperfusion injury following PCI often leads to infarct expansion due to theno reflowphenomenon in the microvasculature of thearea at riskMultiple mechanisms are thought to contribute tono reflowand no effective treatment to ameliorateno reflowand infarct expansion during reperfusion has been identified in large randomized clinical trials following STEMI and PCIEndoProtechInchas developed a novel therapeutic approach that alters the lipid content of endothelial cellsECsduring PCIwhich has a stabilizing effect on the microvascular endothelium and amelioratesno reflowin thearea at riskduring reperfusionThe overall goal of this project is to demonstrate the safety and efficacy of our therapy in enhancing myocardial salvage following STEMI and PCIThe aims of this Phase II proposal areEvaluate efficacy of therapy in reducingno reflowand infarct sizeCharacterize the effect of the therapy on regenerative reparative cells involved in early post MI remodelingPerform pharmacokinetic studies of therapyandDetermine stability of therapy under various storage conditionsSuccessful completion of these aims will determineathe effective dose of our therapy when delivered during PCIbthe effect of the therapy onno reflowin the area at riskand cprotocols for optimal production and longer shelf life of the therapyAims are consistent with studies that will provide partial support for a new drug application to the FDA Percutaneous coronary interventionPCIto reopen blocked coronary arteries enhances myocardial salvage and outcomesbut when blood flow is re establishedreperfusionit can lead to infarct expansionThis infarct expansion is caused in part by theno reflowphenomenon that occurs in the microvasculature of thearea at riskduring reperfusionTo reduce infarct expansion during reperfusionEndoprotechInchas developed a lipid based treatment that protects the endothelium in the microvasculature from thenoreflowphenomenon and enhances myocardial salvage following PCI!
