Staphylococci, especially
coagulase negative staphylococci (CONS), are responsible for over 75 % of late-onset
infections in very low birth weight infants. These
infections cause increased length of
hospital stay, need for
antibiotics, and cost of medical care. Several
drug companies have developed and evaluated hyperimmune polyclonal and
monoclonal antibodies for the prevention of neonatal
staphylococcal infection including 1)
Altastaph by North American Biologics Inc., 2)
Veronate by Inhibitex Inc., and 3)
Pagibaximab by Biosynexus Inc, and Glaxo Smith Kline Inc. We will review the development and status of these potential products.
Altastaph is a S. aureus serotype 5 and 8
vaccine induced hyperimmune polyclonal antibody whose development has been placed on hold due to its failure to demonstrate any trend toward efficacy in a recently completed Phase II study.
Veronate is a polyclonal antibody obtained by
plasmapheresis from donors with high titers of MSCRAMM (microbial surface components recognizing adhesion matrix molecules) activity against CONS whose development has been placed on hold due to its failure to demonstrate effectiveness in a recently completed Phase III study.
Pagibaximab is a humanized mouse chimeric
monoclonal antibody (previously known as BSYX-A110) directed against
lipoteichoic acid (LTA), a major cell wall component of gram-positive bacteria, that has recently completed a Phase II study suggesting efficacy and is being developed further for clinical investigation.