Anti-Endotoxin Monoclonal Antibodies

Abstract
Several monoclonal antibodies directed against bacterial lipopolysaccharide (endotoxin) are being developed for the adjunctive treatment of gram-negative sepsis. Two of these, E5 (XOMA, Berkeley, Calif.)1 and HA-1A (Centocor, Malvern, Pa.),2 have been studied in clinical trials and evaluated by the Food and Drug Administration for use in the United States. An open advisory-committee meeting was held by the FDA on September 4, 1991, at which new information was presented about the preclinical and clinical studies of these two products.3 This article discusses some of the issues relating to the development and evaluation of these agents in the context of this . . .