Linked Life Data

19268719

Source:http://linkedlifedata.com/resource/pubmed/id/19268719

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2009-4-10
pubmed:abstractText
A chimerized (murine/human) monoclonal antibody (pagibaximab) against lipoteichoic acid (LTA) and protective in animal models for coagulase-negative staphylococci (CONS) and Staphylococcus aureus bacteremia, was developed for prevention of staphylococcal infection in high-risk populations. This open label two-dose study of a single intravenous dose of 3 or 10 mg/kg of pagibaximab evaluated the safety/tolerability, pharmacokinetics, and opsonophagocytic activity of pagibaximab in healthy adults. Eight participants were enrolled (four in each dose group). No infusion, drug, or dose related adverse events occurred. Serum anti-LTA levels were dose-related; mean concentrations peaked at 87.75 and 259.24 microg/mL for 3 and 10 mg/kg groups, respectively. The half-life (beta) of pagibaximab was approximately 33 days. Opsonophagocytic activity of serum samples on a human clinical isolate of Staphylococcus epidermidis in a standard bacterial killing assay was dose-related, and peaked at a mean of 88.5 and 95.5% at 1:90 dilution for 3 and 10 mg/kg groups, respectively. Serum anti-LTA and opsonophagocytic activity levels exhibited statistically significant correlation. The results suggest that pagibaximab at 3 and 10 mg/kg administered as a single intravenous dose in healthy adults appears to: 1) provide preliminary safety and tolerability data, 2) produce dose-related serum anti-LTA and opsonophagocytic activity levels, 3) have a half-life similar to other immunoglobulin G1 antibodies, 4) exhibit statistically significant correlation between serum anti-LTA and opsonophagocytic activity levels. This study supports conducting safety and pharmacokinetic trials of pagibaximab in populations at high-risk of developing CONS infection.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
1878-1705
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
9
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
639-44
pubmed:dateRevised
2011-8-2
pubmed:meshHeading
pubmed-meshheading:19268719-Adult, pubmed-meshheading:19268719-Animals, pubmed-meshheading:19268719-Anti-Bacterial Agents, pubmed-meshheading:19268719-Antibodies, Monoclonal, pubmed-meshheading:19268719-Dose-Response Relationship, Drug, pubmed-meshheading:19268719-Female, pubmed-meshheading:19268719-Half-Life, pubmed-meshheading:19268719-Humans, pubmed-meshheading:19268719-Injections, Intravenous, pubmed-meshheading:19268719-Lipopolysaccharides, pubmed-meshheading:19268719-Male, pubmed-meshheading:19268719-Mice, pubmed-meshheading:19268719-Middle Aged, pubmed-meshheading:19268719-Neutrophils, pubmed-meshheading:19268719-Phagocytosis, pubmed-meshheading:19268719-Recombinant Fusion Proteins, pubmed-meshheading:19268719-Serum Bactericidal Test, pubmed-meshheading:19268719-Staphylococcal Infections, pubmed-meshheading:19268719-Staphylococcus aureus, pubmed-meshheading:19268719-Staphylococcus epidermidis, pubmed-meshheading:19268719-Teichoic Acids
pubmed:year
2009
pubmed:articleTitle
Safety and pharmacokinetics of a chimerized anti-lipoteichoic acid monoclonal antibody in healthy adults.
pubmed:affiliation
Department of Pediatrics, Baylor College of Medicine, Houston, TX 77030, USA. lweisman@bcm.edu
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't