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Ash Access Technology, Inc. Completes Patient Enrollment in AZEPTIC Trial for Zuragen®
Twenty-Five Dialysis Facilities Across the United States Are Participating In the Study
JANUARY 24, 2008 04:23 PM ET (Lafayette, Indiana) - - - Ash Access Technology, Inc., a privately held specialty pharmaceutical and medical device company focused on vascular access innovations announced today that patient enrollment in the AZEPTIC Trial for its flagship antimicrobial / antithrombotic therapy Zuragen® was completed in December of last year. The pivotal trial is a multi-centered, randomized study evaluating the efficacy and safety of Zuragen® for the prevention and treatment of catheter-related bloodstream infection (CRBSI) in end-stage renal disease patients requiring the use of a tunneled central venous catheter for hemodialysis compared to heparin, the current standard of care. The trial enrolled 415 patients at 25 dialysis facilities across the United States. Portions of the AZEPTIC Trial were financed through grants awarded by the National Institutes of Health (NIH) and the Indiana 21st Century Research and Technology Fund.
Zuragen® is a non-antibiotic, injectable solution that is administered into a patient's catheter at the conclusion of each hemodialysis session. The product's unique components have demonstrated a novel synergy which has led to significant and rapid efficacy against a broad spectrum of bacteria and complete elimination of biofilm in pre-clinical studies. Patients will be completing treatments in the AZEPTIC trial during the 2nd Quarter of this year with final study results expected shortly thereafter.
"We are very grateful to the patients and study sites that are participating in the AZEPTIC Trial. Completing enrollment is a significant milestone achievement and we are appreciative of the efforts of all the team members who have joined us in this pioneering research. We are confident Zuragen® will demonstrate a compelling efficacy and safety profile in the clinic which should result in a new standard of care for any patient requiring a catheter for vascular access,” Bob Truitt, President and CEO of Ash Access Technology, Inc.
The Centers for Disease Control has identified CRBSI as 1 of its 7 major healthcare challenges because of an estimated 200,000 to 400,000 episodes annually in the United States. 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. Recent reports from the NNIS and CDC continue to show alarming and rapidly increasing rates of resistance of some of the more common pathogens associated with CRBSI to antibiotics (Methicillin and, more recently, Vancomycin).
“Zuragen® is an exciting technology that holds tremendous promise to address a significant unmet medical need – the ability to prevent and treat life-threatening catheter-related bloodstream infections without contributing to the rising antibiotic resistance of common bacterial strains. Zuragen® could have a considerable impact on a patient's quality of life. I am confident it will become an important tool in the fight against infection for practitioners in the dialysis community and acute care settings,” said Dr. Stephen Ash, Chairman and Director, Research and Development.
About Ash Access Technlogy, Inc.
Ash Access Technology, Inc. is a privately held specialty pharmaceutical / medical device company focused on the development and commercialization of proprietary products and devices to improve vascular access outcomes. The Company's diverse product portfolio includes innovative hemodialysis and peritoneal dialysis catheters and a unique antimicrobial / antithrombotic solution, ZuragenTM, being developed for the prevention and treatment of catheter related bloodstream infection (CRBSI). Ash Access Technology is located in Lafayette, Indiana in the INOK Business Center.
The statements made in this document contain certain forward-looking statements that involve a number of risks and uncertainties. Words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," or variations of such words and similar expressions, are intended to identify such forward-looking statements. Investors are cautioned that actual events or results may differ from the Company's expectations. In addition to the matters described above, the ability of the Company to develop its products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, as well as other risk factors may affect the actual results achieved by the Company.