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OFFICIAL RELEASE
Ash Access Technology, Inc. Investigational
Antimicrobial / Antithrombotic Therapy (Zuragen™) Pivotal Clinical
Trial Begins
Patient Enrollment Initiated at Key Study Sites
for Innovative, Injectable Therapy for CRBSI
October 2, 2006 4:54 PM EST (Lafayette, Indiana) - - - 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™. The
clinical trial is a multi-centered study evaluating the efficacy
and safety of Zuragen™ 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™, 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™
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™
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™ 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™ 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. 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. |