Despite advances in our understanding of excessive alcohol intake-related tissue injury, high morbidity and mortality due to infections in alcohol abusers remain a prominent challenge. Milk fat globule epidermal growth factor-factor VIII (MFG-E8) is involved in the clearance of apoptotic cells. We previously discovered that acute alcohol exposure and infections down regulate MFG-E8 expression. Administration of recombinant murine MFG-E8 (rmMFG-E8) reduces apoptosis, decreases inflammatory responses, and attenuates organ damage in a rat model of acute alcohol exposure and subsequent polymicrobial infections. However, one obstacle that hampered development of MFG-E8 as a therapeutic agent for alcoholic patients with infections is the potential immunogenicity of animal proteins in humans. To overcome this, we successfully expressed and purified recombinant human MFG-E8 (rhMFG-E8), and our data indicated that rhMFG-E8 is as effective as animal MFG-E8. In our SBIR Phase I Contract, we scaled up the production of recombinant human MFG-EB (rhMFG-EB) and confirmed the beneficial effect of rhMFG-EB in a rodent model of acute alcohol exposure and sepsis. The goal of this SBIR Phase II Contract is targeted towards completing the preclinical development of rhMFG-EB as a novel therapeutic agent in reducing mortality after alcohol/sepsis.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research – Phase II (N44)
Project #
275201300007C-0-0-1
Application #
8757477
Study Section
Project Start
2013-02-21
Project End
2015-02-20
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$470,529
Indirect Cost
Name
Therasource, LLC
Department
Type
DUNS #
144994972
City
Roslyn
State
NY
Country
United States
Zip Code
11576