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Therapeutic Human Hyperimmune Polyclonal Antibodies against Staphylococcal Enterotoxin B

Award Information
Agency: Department of Defense
Branch: Army
Contract: W81XWH-08-C-0004
Agency Tracking Number: A072-154-0249
Amount: $109,774.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: A07-154
Solicitation Number: 2007.2
Solicitation Year: 2007
Award Year: 2007
Award Start Date (Proposal Award Date): 2007-10-19
Award End Date (Contract End Date): 2008-04-18
Small Business Information
Frederick Innovative Technology Center 4539 Metropolitan Ct.
Frederick, MD 21704
United States
DUNS: 601000750
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 M. Javad Aman
 President & Chief Scientific Office
 (301) 644-3910
Business Contact
 Cheryl Mullican
Title: Executive Assistant
Phone: (301) 694-2999
Research Institution

Research Proposed: Determine the feasibility of developing human hyperimmune serum (HIS) against staphylococcal enterotoxin B (SEB). PROBLEM/OPPORTUNITY: Staphylococcus aureus is associated with up to 25% of invasive infections in hospitals and community. Staphylococcal exotoxins (SEs), including SEB, are key virulence factors leading to toxic shock syndrome (TSS). SEB has been weaponized and can cause human incapacitation and mortality. No countermeasures targeting SEs are currently available for human use. Integrated BioTherapeutics (IBT) has a cGMP produced SEB vaccine (STEBVax; currently in IND process) that may be used to generate HIS to treat SEB intoxication. PLAN/PROCESS OUTLINE: Screen human intravenous immunoglobulin and monkey immune sera and use, as HIS surrogates to develop assays and SOPs to test sera for inhibition of superantigenic activity. Evaluate neutralizing activity of antibodies in vitro (>80% inhibition) and in mice (>80% protection). PHASE I OPTION: Develop a clinical protocol for plasmapheresis of volunteers vaccinated with STEBVax. PHASE II PLAN: IBT plans for a cost shared phase II to conduct plasmapheresis for collection of anti-SEB HIS in partnership with Omrix Biopharmaceuticals, a leading plasma fractionation company, using the IND status of STEBvax and preclinical evaluation of anti-SEB HIS in anticipation of filing an IND with FDA.

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

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