BSYX-L210 meets endpoints of safety and microbiological activity.

2003 NOV 12 - (NewsRx.com & NewsRx.net) -- Biosynexus, Inc., a privately held biotechnology-pharmaceutical company, announced completion of the phase I/II study of its topical anti-staphylococcal cream, BSYX-L210, for the eradication of Staphylococcus aureus nasal carriage.

The study met its endpoints for safety and microbiological activity. The final data will be submitted for publication.

BSYX-L210 is a topical, intranasal cream specifically formulated for use in eradicating S. aureus from the noses of individuals at high risk for infection or transmission of S. aureus. The active agent in BSYX-L210 is lysostaphin, an anti-staphylococcal enzyme. Lysostaphin is ultra-bactericidal against antibiotic sensitive and antibiotic resistant strains of S. aureus, killing greater than three logs of bacteria in 30 minutes.

In a previous phase I study, 18 volunteers received BSYX-L210 or placebo. Seven of the volunteers were S. aureus nasal carriers. Four carriers received BSYX-L210 and three carriers received placebo. All four carriers were completely cleared with BSYX-L210, while none of the three carriers receiving placebo cleared. There were no significant adverse events.

"We are pleased to see the clinical trials validate the results from our preclinical model," stated James Mond MD, PhD, chief scientific officer of Biosynexus. The data from these studies was published in the May 2003 issue of Antimicrobial Agents and Chemotherapy and showed that BSYX-L210 is superior to mupirocin, the only agent approved by the FDA for eradicating S. aureus nasal colonization, as well as Nisin, a potent anti-staphylococcal peptide. Several anti-microbial peptides have failed in human clinical trials.

"The dangers of community- and hospital-acquired Staph infections are becoming more widely known with the increasing incidence of outbreaks across the country," explained Gerald Fischer MD, CEO of Biosynexus. "Up to 30% of the general population actually carries S. aureus - the most common cause of these infections - in their nasal passages. Individuals with compromised immune systems, such as those undergoing dialysis or with diabetes, have a much higher nasal colonization rate, with some patient groups approaching 50%. S. aureus nasal colonization is highly ...