Healthcare Industry News: hemodialysis
News Release - October 2, 2006
Ash Access Technology, Inc. Investigational Antimicrobial / Antithrombotic Therapy (Zuragen(TM)) Pivotal Clinical Trial BeginsPatient Enrollment Initiated at Key Study Sites for Innovative, Injectable Therapy for CRBSI
LAFAYETTE, IN--(Healthcare Sales & Marketing Network)--Oct 2, 2006 -- Ash Access Technology, Inc., a privately held specialty pharmaceutical and medical device company, announced that patient enrollment had been initiated this August for the pivotal clinical trial of its flagship antimicrobial / antithrombotic therapy, Zuragen(TM). The clinical trial is a multi-centered study evaluating the efficacy and safety of Zuragen(TM) for the prevention of catheter related bloodstream infection (CRBSI) in dialysis patients. The trial will enroll 400 patients and consist of 10 study sites, eight of which are associated with DaVita Inc., and two independent clinics in Bakersfield, CA, and Lafayette, IN. The company will finance a portion of the trial through an SBIR Phase I & II NIH grant awarded in 2005 and a grant from the Indiana 21st Century Technology Fund received this year.
Zuragen(TM), also known as AAT-023 for clinical study purposes, is a non-antibiotic, injectable therapy designed to significantly reduce the incidence of catheter related bloodstream infections (CRBSI) as well as maintain catheter patency. The product's unique antimicrobial and antithrombotic components have demonstrated a novel synergy which has led to significant efficacy against a broad spectrum of common bacteria associated with CRBSI and complete elimination of biofilm in pre-clinical lab studies.
"We are excited that patient enrollment has been initiated in our pivotal trial. We have a high level of confidence in our clinical research team and their ability to execute the trial. We believe that if Zuragen(TM) can meet the primary and secondary endpoints established in our study protocol that it will have a tremendous impact on the associated morbidity and quality of life of dialysis patients. The Zuragen(TM) pre-clinical data has demonstrated excellent efficacy against both gram positive and negative strains of bacteria associated with CRBSI as well as complete eradication of biofilm," according to Roland Winger, Vice President of Quality & Engineering at Ash Access Technology, Inc.
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 ($25 million - $55 million per incident). In addition, both the NNIS and CDC continue to report alarming rates of antibiotic (Vancomycin / Methicillin) resistance to the most common strains of bacteria associated with CRBSI including S. aureus, S. epidermidis, P. Aeruginosa and E.Coli.
"Zuragen(TM) has tremendous potential to prevent life-threatening catheter-related infections and the associated complications. It is an exciting technology that addresses a significant unmet medical need in large patient populations. While our pivotal trial is being conducted in hemodialysis, we feel the broader applications of Zuragen(TM) are just as significant. Patients in the acute care/hospital setting are experiencing an explosion in the rates of CRBSI and the medical community is searching for effective solutions without contributing to the escalation in antibiotic resistance," said Bob Truitt, President & CEO of Ash Access Technology, Inc.
Ash Access Technology, Inc. (www.ashaccess.com) 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 R. 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.
Source: Ash Access Technology
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