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Inhibition of Galectin-3 for Therapy of Remodeling After Myocardial Infarction Supplement

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AG054386-02
Agency Tracking Number: R44AG054386
Amount: $2,001,205.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA16-287
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-04-15
Award End Date (Contract End Date): 2020-03-31
Small Business Information
665 3RD ST STE 250
San Francisco, CA 94107-1953
United States
DUNS: 031636660
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 CONSTANCE JOHN
 (415) 221-4810
 constance.john@ucsf.edu
Business Contact
 CONSTANCE JOHN
Phone: (415) 495-5570
Email: constancejohn@mandalmed.com
Research Institution
N/A
Abstract

This Administrative Supplement is for AimCboldface fontthat is focused on testing
efficacy of a protein inhibitor of galectinin an ischemia reperfusionI Rminiswine model of
myocardial infarctionMIIn the Specific Aims for the Phase II projectAimsshown belowwe are testing efficacy in animal models of MIperforming pharmacokinetics and toxicologyand
developing GLP GMP manufacturing processesAimTo better understand efficacy of GalC therapy in animal modelsADetermine efficacy and optimal dosage of GalC in rat I R MI modelBDetermine efficacy of GalC in comparison to mineralocorticoid receptorantagonistMRAand in combination with ARB in rat I R MI modelCDetermine efficacy of GalC in miniswine I R model of MIAimTo develop GLP GMP production methods and a formulation for GalCAimTo perform pharmacokinetic studies and acute subacute toxicology in ratsIn Phase Iwe found that in rats treated with our protein inhibitor of galectinthere was a
very statistically significant reductionP andltin left ventricular end diastolic volumeEDVatdaysbut no improvement atdaysThe response to injury takes a longer time in larger
animalsBased on our Phase I resultswe will increase total treatment and observation period
tomonthsdaysin the miniswine I R model to detect a reduction in EDVThere is a greater likelihood today that in Phase II clinical trials FDA would accept infarct
sizewhich can be determined from cardiac magnetic resonanceCMRas a surrogate
endpoint rather than only LV volume and ejection fractionwhich can be quantified by
echocardiographythan there was when we submitted the Fast Track application two years agoThusin analysis of the miniswinewe will use CMR imagingwhich that can determine primary
infarct size as well as ejection fraction and EDV because in filing an Investigational New Drug
application these data could better inform FDA regarding the potential efficacy in humans PROJECT NARRATIVE
The overall goal of this project is to develop a protein inhibitor of galectinas a biologic to prevent and treat
harmful remodeling after myocardial infarction andtherebyimprove cardiac function and reduce mortality
from subsequent heart failureMyocardial infarction is the most common cause of cardiac morbidity and
mortality in the western worldThe annual incidence in the United States isnew attacks andrecurrent attacksBecause current standard practice of minimizing time from onset of myocardial infarction to
re opening of the blocked artery has greatly reduced the incidence of death from acute myocardial infarctionheart failure subsequent to myocardial infarction has become the main mortality associated with coronary
events

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

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