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Human Lactoferrin in Acetaminophen Overdose-Induced Liver Failure

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AA022260-01
Agency Tracking Number: R41AA022260
Amount: $201,920.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAAA
Solicitation Number: PA11-097
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
320 East Vine Drive
United States
DUNS: 932816929
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (303) 724-4019
Business Contact
Phone: (970) 219-3580
Research Institution
University of Colorado Denver Grants and Contracts, Mail Stop F428 Anschutz Medical Campus, Building 500 13001
AURORA, CO 80045-0508
United States

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 Nonprofit College or University

DESCRIPTION (provided by applicant): An acute or cumulative overdose of acetaminophen (APAP), following either therapeutic overdose or suicide attempts, can cause severe liver damage with the potential to progress to liver failure. APAP overdose accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year, making APAP the most frequent cause of drug-induced liver failure in the U.S. Currently, N- acetylcysteine (NAC) is the only antidote used clinically to ameliorate APAP-induced liver injury (AILI). However, the effectiveness of NAC declines rapidly after APAP ingestion. Therefore, developing new life-saving treatment is critically needed. In our preliminary study with milk- derived lactoferrin, we demonstrate that the lactoferrin has a profound hepato-protective effect in a murine model of AILI. In the present proposal, we will team up with scientists from Ventria Bioscience to investigate the feasibility of developing a noveltreatment o AILI with recombinant human lactoferrin (rhLF) produced by Ventria. There are two aims in the present proposal. Aim 1. Purification of rhLF from rice suitable for intravenous (i.v.) administration. We will purify sufficient amount of rhLF fromrice grain and formulate it for systemic administration to mice. Aim 2. Investigation of the feasibility of the rhLF in attenuating AILI in mice. We will determine the condition in which rhLF can exert maximal/optimal effect on AILI. We expect that the study will prove that the rhLF is able to protect mice from liver injury due to overdose of APAP and establish a base for further study in phase II STTR to develop a novel therapy for AILI. PUBLIC HEALTH RELEVANCE: Acetaminophen overdose cause severe liver damage and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths each year in the U.S. Based on our preliminary study, we propose to develop a novel therapeutic treatment with recombinant human lactoferrin.

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

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