Validation of platelet expression of FC?riia as a precision tool

Ended Project Grant Awarded Last action

Award ID
R44HL166003
Recipient
Awarding agency
Obligated
$3,352,388

Award facts

Assistance listing
93.837 Cardiovascular Diseases Research
Completion date
Place of performance
Vermont, USA

Award details come from USAspending.gov.

Description

Abstract
The american heart association estimates that, in 2022, about 720,000 americans will have a first coronary event and 335,000 will have a recurrent event, of which, approximately 87% are ischemic (thrombotic). Anti- thrombotic therapy reduces the risk of recurrent ischemic events at the cost of a greater incidence of bleeding complications. Patients at low thrombotic/ischemic risk should benefit from shortened treatment whereas patients at high thrombotic/ischemic risk should derive greater absolute benefit from longer term treatment with more powerful antiplatelet therapy. Currently available tools such as clinical risk scores and platelet function testing are inadequate to effectively individualize cardiovascular care, and effective precision medicine strategies to enable clinicians to target patients with high residual risk are lacking. Platelet function tests effectively identify patients at risk but failed when used in trials designed to guide treatment. Key weaknesses of platelet function tests include that they demonstrate substantial intra-individual variability, are influenced by both assay conditions as well as the treatment of the patient, and that they measure platelet reactivity in response to a select agonist or group of agonists. To address this GAP in patient care, prolocor identified a biomarker, fcriia, on the surface of platelets. When platelets activate, fcriia amplifies platelet activation. Thus, increased platelet fcriia increases platelet reactivity and leverages the prognostic implications of platelet function tests. Compared to currently available platelet function tests, expression of fcriia shows less intra-individual variability, is substantially less sensitive to perturbations related to assay conditions, and predicts increased platelet reactivity in response to a variety of agonists. In a preliminary study of 197 patients, COX regression analysis demonstrated that platelet expression of fcriia was the sole covariate (hazard ratio 3.9, p=0.035) associated with an increased risk of heart attack, stroke, and death when age, diabetes, and prior revascularization were included as covariates. Thus, quantifying platelet fcriia expression is a novel method to identify cardiovascular risk and should serve as a powerful precision medicine tool. Prolocor has since refined the assay by developing antibodies that bind to fcyriia on the surface of platelets that have been fixed with formaldehyde. Initial analytic testing has demonstrated excellent precision (coefficient of variation of repeated tests

Transactions

Action Obligated Date
Amendment $0
Amendment $50,000
Amendment $693,288
Amendment $693,288
Amendment $687,938
Amendment $0
Amendment $0
Amendment $0
Amendment $613,937
Original award $613,937

Quick answers

Who received award R44HL166003?

R44HL166003 was awarded to Prolocor Inc. by National Heart Lung and Blood Institute (National Institutes of Health) on August 11, 2022.

How much is award R44HL166003 worth?

$3,352,388 has been obligated on R44HL166003.

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