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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. |