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Recombinant Lactoferrin and Necrotizing Enterocolitis

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
71383
Program Year/Program:
2004 / STTR
Agency Tracking Number:
HD046305
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
AGENNIX, INC.
AGENNIX, INC. 8 GREENWAY PLZ, STE 910 HOUSTON, TX 77046 0892
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: Yes
 
Phase 1
Fiscal Year: 2004
Title: Recombinant Lactoferrin and Necrotizing Enterocolitis
Agency: HHS
Contract: 1R41HD046305-01A1
Award Amount: $115,800.00
 

Abstract:

DESCRIPTION (provided by applicant): This feasibility study is based on our hypothesis that recombinant human lactoferrin [rhLF] can prevent or reduce severity of necrotizing enterocolitis [NEC]. NEC is mainly a disease of very low birth weight [VLBW] human infants. It is a leading cause of morbidity and mortality in neonatal intensive care units, with incidence of approximately 10 percent in VLBW infants and mortality of about 25 percent. Hospital costs associated with surgical and medical NEC are very high. Studies show NEC occurs less frequently in breast fed infants. Sufficient amounts of a mother's milk are often not available to prevent abnormal bacterial colonization and to enhance gut development in the crucial days following birth. We anticipate that all VLBW infants would benefit from receiving rhLF for at least 4 weeks after birth or until full human milk feedings are established. Biotechnology has made rhLF available for drug development. LF is known to have anti-bacterial, anti-inflammatory and immuno-stimulating properties. It also promotes gut epithelial growth. Using a neonatal rat model of bacterial translocation, we have shown already that rhLF is highly effective in decreasing bacteremia, illness and death from Escherichia coil-related intestinal infection. Formula-fed newborn rats exposed to hypoxia develop an intestinal disease similar to human NEC. As rat milk does not contain LF, we plan to use this long-accepted neonatal rat model to test whether adding rhLF could prevent or attenuate this disease. Our primary specific aim is therefore to show the efficacy of oral rhLF in preventing or attenuating NEC in the newborn rat model. Secondary aims, utilizing the tissues obtained from animals used in the primary specific aim, will continue beyond the time-frame of this application to explore the mechanisms by which the benefits of rhLF might occur. The data generated by this research are essential for the FDA to grant Investigational New Drug [IND] status for rhLF, and thus enable a NEC clinical trial in human neonates.

Principal Investigator:

Karel Petrak
7135521091
AVARADHACHARY@AGENNIX.COM

Business Contact:

Rick Barsky
7135521091
RBARSKY@AGENNIX.COM
Small Business Information at Submission:

AGENNIX, INC.
AGENNIX, INC. 8 GREENWAY PLZ, STE 910 HOUSTON, TX 77046

EIN/Tax ID: 954405779
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Research Institution Information:
UNIVERSITY OF CALIFORNIA DAVIS
UNIVERSITY OF CALIFORNIA DAVIS
Davis, CA 95616
RI Type: Nonprofit college or university