ANTIENDOTOXIN MONOCLONAL-ANTIBODIES IN SEPSIS - LESSONS FROM RECENT CLINICAL-TRIALS

Gram-negative bacteria release lipopolysaccharide (endotoxin) that cau ses sepsis and septic shock. Monoclonal antibodies against endotoxins have been proposed as a treatment of sepsis. One such antibody, nebacu mab (HA-1A), was released onto the market in some European countries a nd its approval in the USA was recommended. However, doubts raised by the lack of reproducible preclinical data, and by an independent reana lysis of the results of the first clinical trial, led to a further cli nical trial. This second trial revealed an increase in mortality in ne bacumab-treated patients. The trial was stopped and the drug withdrawn from the market. To avoid such disappointments, the marketing of new biotechnology products should be based on critical scientific analysis , free from commercial pressures, of thorough, reproducible and consis tent preclinical and clinical studies.