Biosynexus Presents Results of First Clinical Study of an Anti-staphylococcal Monoclonal Antibody
 
Rockville, MD, May 14, 2002
 
Biosynexus Incorporated announced clinical results for the first monoclonal antibody in the field of prevention of staphylococcal infections. BSYX-A110, a chimeric anti-lipoteichoic acid (LTA) antibody, demonstrated outstanding safety, pharmacokinetics, and serum anti-staphylococcal opsonic activity in healthy adults. Studies are currently underway in premature infants at the Baylor College of Medicine.
 
An open label, dose ranging Phase I study of BSYX-A110 involved eight healthy volunteers in two dosage groups of 3 and 10 mg/kg of a 10 mg/ml product. They were treated with a single intravenous injection and monitored for 28 days. Pharmacokinetics were assessed by anti-LTA antibody levels measured by ELISA. The standard neutrophil mediated opsonic assay was used to measure the serum anti-staphylococcal killing activity.
 

• Independent pre-clinical studies demonstrate protection against S. epidermidis and S. aureus in clinically relevant animal models.
   
  
• Primary endpoints of safety and tolerability, and secondary endpoints of anti-LTA antibody levels and opsonic activity were achieved.
   
  
• Anti-LTA levels were dose related, peaking at 264 ±54 ug/ml immediately and at 101±39 ug/ml at 28 days. Bacterial killing levels were dose-related, peaking at 96±2% immediately and at 69±19% at 28 days. These levels were highly correlated (R=0.67). The antibody demonstrated a half-life of 30±10.4 days - similar to other IgG1 antibodies.
   
  
• BSYX-A110 was well tolerated, and no safety issues were identified. There were no infusion, drug or dose-related adverse events observed, and no significant changes in baseline vital signs, blood or urine readings.
   
  
• HAMA/HACA responses were not detected.