Biosynexus Announces Successful Completion of Phase I/II Trial for Topical Anti-Staph Cream for Eradication of S. aureus Nasal Colonization
 
BSYX-L210 Meets Endpoints of Safety and Microbiological Activity
 
Gaithersburg, MD, October 14, 2003
 
Biosynexus Incorporated, a privately held biotechnology-pharmaceutical company, today announced completion of the Phase I/II study of its topical anti-staphylococcal cream, BSYX-L210, for the eradication of S. 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 pre-clinical 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, Chief Executive Officer 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 correlated with hospital infections and the spread of methicillin resistant Staphylococcus aureus (MRSA).”
 
Each year, more than two million patients contract an infection while in the hospital in the United States, according to the Centers for Disease Control and Prevention (CDC). One-quarter of hospital acquired infections are caused by S. aureus. In addition to the harm caused to patients, these infections are responsible for increasing health care costs in the U.S. by $5-10 billion annually. A recent study in the New England Journal of Medicine demonstrated that using a topical antibiotic to eradicate S. aureus nasal colonization from patients prior to surgery reduced S. aureus infections by almost 50% (4.0% vs 7.7% p=.02).
 
“The staphylococcal bacteria are carried harmlessly by many people, but become dangerous when they spread to a person’s blood, bones, heart or other internal organs, resulting in serious complications, and even death. High-risk patient populations are particularly susceptible to S. aureus infections, such as those undergoing surgery, those fighting chronic illnesses or newborns whose immune systems are not yet developed,” commented Dr. Fischer. “BSYX-L210 is being developed to provide doctors with an easy-to-administer, effective method to restrict the spread of S. aureus in both nasal carriers and susceptible patient populations. We hope this product will help hospitals limit these infections, thus reducing patient complications, as well as the related costs brought on by extended hospital stays.”
 
Nasal eradication of S. aureus presents a valuable alternative to vaccination, another measure being explored to prevent staph infections from occurring. BSYX-L210 has several advantages to a vaccine:

• Vaccines require several months to generate protective antibodies, while BSYX-L210 eradicates staph in hours;
   
  
• Vaccines require the body to generate an immune response, which may be difficult for those populations which are most susceptible to S. aureus infections; and
   
  
• Vaccines are invasive, thus causing greater safety concerns, while BSYX-L210 is topical and the active ingredient, lysostaphin, is not absorbed into the bloodstream.