Novel Anti-Inflammatories for Cardiopulmonary Bypass

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44HL080934-02
Agency Tracking Number: HL080934
Amount: $1,485,330.00
Phase: Phase II
Program: SBIR
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
DUNS: 190155171
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 () -
Business Contact
Phone: (440) 477-9874
Research Institution
DESCRIPTION (provided by applicant): There is evidence that the complement alternative pathway (AP) contributes significantly to the generation of pro-inflammatory agents in post-CPB inflammation. Complement activation products such as C3a, C5a, and C5b-9 have been found in blood samples of patients undergoing bypass. NovelMed has identified a murine monoclonal antibody to factor B which prevents complement and cellular activation. The antibody also prevents the elastase and TNF production. Murine monoclona l antibodies can not be used as therapeutics due to Human Anti Mouse Antibody (HAMA) response. In this phase II proposal we propose to convert the murine monoclonal into a humanized version of the monoclonal. NovelMed currently has three patents pending on the factor B monoclonal antibodies. The phase II studies should result in an Investigational New Drug (IND) application for the treatment of inflammatory conditions. PUBLIC HEALTH RELEVANCE: Currently there is no FDA approved therapeutic for down regulati ng inflammation in bypass. NovelMed's lead drug BikajuMabTM inhibits C3a, C5a, C5b-9 formation. As a result, activation of neutrophils, monocytes, and platelets is also prevented. In addition BikazuMabTM inhibits TNF-alpha and elastase production, major ha ll mark of inflammatory conditions. Humanized version of the monoclonal is expected to produce similar results and thus provide patient benefit in cardiopulmonary bypass.

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

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government