Recombinant 21 kDa N-terminal fragment of human bactericidal/permeability-increasing protein (rBPI21):: progress in the clinic

rBPI(21) is a recombinant 193 amino acid protein derived from human BPI, a naturally occurring 456 amino acid host defense molecule made in neutrophils. rBPI(21) possesses multiple properties which include binding, clearing and neutralizing bacterial endotoxin, killing Gram-negative and Grampositive bacteria, and enhancing bactericidal activity of a wide range of antibiotics. Neuprex(R), the intravenous formulation of rBPI(21), has been evaluated in over 1700 patients to date in human volunteer studies and five Phase I/II indications, involving patients with meningococcemia, hemorrhagic trauma, complicated abdominal infections, partial liver resections and cystic fibrosis. The product has demonstrated an excellent safety profile and evidence of biological activity in every study completed to date. Thus far, two indications, meningococcemia and hemorrhagic trauma, have moved into Phase III trials.