Novel Anti-Inflammatories for Cardiopulmonary Bypass

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.