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Ash Access Technology’s Investigational Antimicrobial/Anthithrombotic Therapy Shows Significant Promise in Pre-clinical Trials for Preventing Catheter-Related Bloodstream Infections

AAT-023 Demonstrates Rapid, Broad Spectrum Efficacy Against Common Bacteria Strains Associated With Deadly Infections

Wednesday, May 4, 2005 7:17 AM EDT - - - (Lafayette, Indiana) Ash Access Technology, Inc., has released pre-clinical laboratory results that demonstrate the effectiveness of their emerging antimicrobial / antithrombotic therapy, AAT-023, for the prevention and treatment of catheter-related bloodstream infections (CRBSI).

According to the Centers for Disease Control, the magnitude of CRBSI in the U.S is significant with an estimated 200,000 to 400,000 episodes annually. Studies have shown that mortality rates associated with CRBSI range from 12 – 25% while annual healthcare costs for treating these infections may exceed $2 billion.

In the pre-clinical tests, AAT-023 was studied along with heparin to evaluate the antimicrobial efficacy (time and duration of complete pathogen eradication) against both gram positive and gram negative strains of bacteria. Testing was done under rigorous conditions to simulate as best as possible the environment of a central venous catheter. High concentrations of bacteria were exposed to growth medium and then placed in heparin and AAT-023. The heparin arm showed little to no efficacy for all bacteria and times tested. AAT-023, on the other hand, showed significant efficacy against most organisms at 60 minutes and “complete eradication” for all tested pathogens at 24 hours, 48 hours, and 72 hours respectively. Table 1 below highlights the antimicrobial results for both AAT-023 and Heparin. Microbes tested in the pre-clinical laboratory study included all organisms associated with catheter-related bloodstream infections such as Staphylococcus aureus and epidermis, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans.

The FDA granted approval last month for an AAT-023 pivotal clinical trial to be completed at a later date. The study will evaluate the efficacy and safety of AAT-023 vs. heparin in the prevention and treatment of CRBSI. The patient population to be enrolled in the trial will be hemodialysis patients who are using a central venous catheter (CVCD) for their vascular access.

Antimicrobial Effectiveness
Rapid and Broad-Based Kill Profile

Heparin (Baseline)
 
60 min
24 hr
48 hr
72 hr
S. aureus 33591        
S. epidermidis 12228        
E. faecalis 376        
E. coli 25922        
E. coli 35218        
P. aerug 27853        
C. albicans 10231        

Zuragen™ (Zuragen™)
 
60 min
24 hr
48 hr
72 hr
S. aureus 33591        
S. epidermidis 2228        
E. faecalis 376        
E. coli 25922        
E. coli 35218        
P. aerug 27853        
C. albicans 10231        

Fully Alive
 
-3-4 Log Kill
 
Complete Kill

Ash Access Technology, Inc. is a privately-held company founded to develop antimicrobial and vascular access technologies, devices and methodologies to combat the deadly and expensive problem of catheter-related bloodstream infections, with an emphasis on prevention. Dr. Stephen A. Ash, Chairman and Director, Research and Development, is a practicing Nephrologist with the Arnett Clinic in Lafayette, Indiana, and is a world-recognized researcher and patent holder in extracorporeal devices, sorbent chemistry, and vascular and peritoneal access devices. Ash Access Technology is located in Lafayette, Indiana in the INOK Business Center.

This press release contains forward-looking statements, which if not based on historical facts, involve risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company's control.