An overview of clinical studies in healthy subjects and patients with severe sepsis with IC14, a CD14-specific chimeric monoclonal antibody.

An overview and discussion of clinical studies with IC14, a chimeric monoclonal antibody directed against human CD14 is presented. These studies include phase 1 trials in: (i) healthy subjects; (ii) healthy subjects challenged with lipopolysaccharide (LPS); and (iii) patients with severe sepsis. The results from clinical studies of IC14 demonstrate this chimeric monoclonal antibody diminishes the systemic inflammatory response directed against LPS and may have potential as a treatment to prevent organ dysfunction in patients with severe sepsis. Furthermore, IC14 treatment was generally well-tolerated in both healthy subjects and severe sepsis patients and did not increase the incidence of secondary infections. Analysis of pharmacology data indicate that higher doses of IC14 are required to saturate membrane-bound CD14 receptors effectively in patients with severe sepsis than in healthy subjects. Finally, the results of non-clinical studies indicate that IC14 should only be administered with concurrent antimicrobial therapy in patients with infection.