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OFFICIAL RELEASE
Ash Access Technology, Inc. Awarded a $2.7M SBIR Fast- Track Grant
from NIH NIDDK to Fund the Pivotal Trial of the Company's innovative,
flagship antimicrobial / antithrombotic therapy
Wednesday, September 14, 2005
11:45 AM EST - - - (Lafayette, Indiana) Ash Access Technology, Inc. received
official written notice that they have been awarded a fast-track
SBIR grant from NIH to fund the pivotal trial of "AAT023",
the company's flagship antimicrobial / antithrombotic therapy designed
to prevent catheter-related bloodstream infections (CRBSI) and
eradicate biofilm. Dr. Stephen R. Ash is named as the Principal
Investigator on the grant, awarded from the National Institute
of Diabetes and Digestive Kidney Diseases (NIDDK).
"We are extremely excited about this award. We know that it
is no small accomplishment to have a NIH sponsored peer-review panel
carefully analyze the details of our plans surrounding the AAT-023
clinical trial and then award a grant of this magnitude," explained
Bob Truitt, President and CEO. "To have the NIH recognize the
importance of our research and pivotal trial reinforces our enthusiasm
about the breakthroughs we expect AAT-023 to provide in the fight
to prevent deadly and costly catheter-related bloodstream infections," said
Mr. Truitt.
The Centers for Disease Control and Prevention (CDC) have recognized
the alarming and growing rate of infection caused by the use of vascular
access catheters and report that there are approximately 250,000
CRBSI incidents annually in the U.S. with reported mortality rates
from 12% to 25% and treatment costs in excess of $2.0 billion each
year.
"We have been very optimistic about the grant request and now
that we have official notice we are excited to get the trial initiated," said
Mr. Roland Winger, Clinical Trial Manager and Vice President Engineering
and Quality Assurance at Ash Access Technology. "We have retained
the services of STATKING Consulting, Inc., a Fairfield, Ohio company,
to provide data entry and statistical services for the trial and
are in final negotiations with a Contract Research Organization and
Site Management Organization."
The clinical trial is designed to study the safety and efficacy
of AAT-023 as a novel antimicrobial / antithrombotic therapy compared
with heparin, the de facto industry standard. In contrast, AAT-023
is designed as a new therapeutic class that has demonstrated in pre-clinical
tests excellent, broad spectrum (both gram positive and gram negative
strains) antimicrobial efficacy and significant biofilm eradication
between uses of a central venous catheters for dialysis. The clinical
trial will be evaluating the safety and efficacy of AAT-023 as a
new therapeutic option to prevent CRBSI and biofilm buildup as well
as provide antithromotic properties similar to Heparin. The clinical
trial will be conducted among chronic kidney disease (CKD) patients
who are undergoing dialysis, according to a protocol approved by
the FDA. The NIH grant will be awarded in two phases based on meeting
short-term milestones in the first phase.
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. |