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Detection and Staging of Liver Fibrosis by Precise MRI (pMRI)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42AA025863-02
Agency Tracking Number: R42AA025863
Amount: $2,000,012.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIAAA
Solicitation Number: PA17-303
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-01
Award End Date (Contract End Date): 2021-06-30
Small Business Information
5075 LAKE FJORD PASS
Marietta, GA 30068-1641
United States
DUNS: 078419511
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 JENNY YANG
 (404) 413-5520
 jenny@gsu.edu
Business Contact
 JIE YANG
Phone: (404) 429-1434
Email: inlightabiosciencesllc@gmail.com
Research Institution
 GEORGIA STATE UNIVERSITY
 
PO BOX 3999
ATLANTA, GA 30302-3999
United States

 Nonprofit college or university
Abstract

Abstract
Chronic liver injury due to alcohol, metabolic dysfunction, viral hepatitis, or autoimmune disease results in liver
inflammation and fibrosis. Liver fibrosis will progress to cirrhosis which is estimated to affect 1–2% of the world’s
population. The major clinical consequences of cirrhosis are liver failure and hepatocellular carcinoma (HCC),
both of which increase the risk of death. Alcoholic liver disease (ALD) is a leading cause of liver disease and
liver-related deaths globally, particularly in developed nations. The current gold standard diagnostic method,
liver biopsy, has many limitations including sampling error and high inter-observer variability with a 33% error
rate even for the diagnosis of advanced stages of liver fibrosis. In addition, liver biopsy is an invasive, painful
and expensive procedure with the risk of complications involving hospitalization and mortality. Liver biopsy is
therefore of limited use for screening or monitoring disease progression. None of several technologies
investigated offers the desired sensitivity and specificity for the detection or staging of fibrosis. The novel contrast
agent developed in our laboratory, ProCA32.Collagen1, combined with innovative processing techniques made
possible by this agent, promise to significantly enhance the precision of MRI in diagnosing and monitoring liver
fibrosis. We have successfully met all of the proposed aims and milestones for Phase I to obtain proof-of-principle
evidence to achieve early detection of liver fibrosis with significantly improved sensitivity and selectivity. We have
demonstrated that ProCA32.Collagen detects in vivo liver fibrosis in mouse models. In this Phase II project, we
will optimize affinity for collagen binding and biodistribution and validate in vivo capability in the early detection
and staging of liver fibrosis. We will obtain essential data required for filing IND applications leading to clinical
translation.Narratives
It is especially important to develop reliable noninvasive methods to monitor patients at risk for liver fibrosis. A
highly effective MRI contrast agent and improved image processing will allow accurate detection of fibrosis at
early stages, monitoring of liver fibrosis progression and response to treatment. When identified in an early or
moderate stage liver fibrosis can be arrested by ceasing alcohol consumption. The contrast agent can later be
applied to many types of fibrotic diseases.

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

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