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Development of Fibrin-Specific Nuclear Probe to Reduce LVAD Adverse Events

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42HL139342-02
Agency Tracking Number: R42HL139342
Amount: $1,496,822.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-01-01
Award End Date (Contract End Date): 2020-12-31
Small Business Information
12042 GARDENGATE DR, Saint Louis, MO, 63146-4809
DUNS: 080307979
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 JAMES BLACKLEDGE
 (636) 866-8262
 jblackledge@galeratx.com
Business Contact
 JUDY BALLARD
Phone: (636) 346-3140
Email: jballard@right-on-site.com
Research Institution
 WASHINGTON UNIVERSITY
 CAMPUS BOX 1054
SAINT LOUIS, MO, 63130-4862
 Nonprofit college or university
Abstract
Despite the myriad major advances in cardiologythe prognosis for patients with severemedically refractive heart failureHFis exceedingly poorApproximatelydeaths occur annually in patients with HF who have endured an impaired quality of life often accompanied by significant economic and personal losses due to recurrent hospitalizationsAt leastof these deaths were directly related to severe heart failureBecause the number of available heart donorsyearhas not increased over the last decadethere is an enormous and expanding gap between medical need for transplant and the woefully low supply of heartsTodayandapos s axial and centrifugal flow left ventricular assist devicesLVADhave reduced size and power requirementsallowing LVADs to become a therapeutic options as a bridge to transplantationBTTand increasingly for destination therapyDTUnfortunately the life saving benefit of LVADs is offset by potential life threatening complications and costly hospital readmissions for bleedinginfectionand thrombosisProphylactic anticoagulation to prevent intra pump thrombus with warfarinin addition to an anti platelet drugexacerbates inherent bleeding complications induced by the high shear high blood flow conditions of the pumpsMulticenter efforts to reduce anticoagulation guidelines tripled the incidence of pump thrombotic complicationsLDHa nonspecific marker of RBC lysisis currently used as the best surrogate indicator for pump thrombosisButgiven clinical results to dateLDH is only an insensitive probably late biomarker of LVAD fibrin accumulationWe have innovated and demonstrated a very high avidity nuclear probe prototypemTc F Ain vitroin excised LVADs operated ex vivoand in rodent modelswhich sensitively localizes thrombus accumulation in LVADsIn Phaseof this Fast track proposal the effectiveness ofmTc F A will be demonstrated in a large animal modelcalveskgusing reimplanted human LVADsKgand a clinical gamma cameraIn Phasethe analyticalchemical processand regulatory development and documentation required to transfer the product candidateFibroScintto contract research organizations for GMP toll manufacturingstability testingand GLP toxicology will be completedFibroScint is anticipated to refine and individualize LVAD clinical management to reduce bleeding eventsthromboembolic complications and pump exchanges

* Information listed above is at the time of submission. *

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