RESEARCH TRIANGLE PARK, N.C., Aug. 29 /PRNewswire-FirstCall/ --
Biotechnology company Icoria, Inc. (OTCBB: ICOR.OB) today announced that it
has received a $1.2 million Phase II Small Business Innovation Research (SBIR)
contract from the National Institute of Environmental Health Sciences,
National Institutes of Health to discover biomarkers for drug-induced liver
injury. This research could lead to the development of new diagnostics for
identifying hepatotoxicity and the progression of liver disease.
Icoria is currently developing multi-analyte biomarker panels to diagnose
drug-induced hepatotoxicity, non-alcoholic fatty liver disease and other liver
problems where present diagnostics approaches may be limited in sensitivity
and accuracy. The contract will support Icoria's continued research into
proprietary serum and urine biomarkers that can measure liver health and
predict the severity of liver pathology.
"Icoria's goal is to develop highly informative, minimally-invasive,
diagnostic tests that can provide health care professionals with more
sensitive and specific views of liver function and how it is affected by drugs
and toxicants," said Thomas Colatsky, Ph.D., Icoria's Chief Scientific
Officer. "Liver injury and its progression to liver disease remain
significant issues in drug development and medical care. We believe this
contract will help us increase our understanding of this critical organ and
how it responds in acute and chronic illnesses."
Drug-induced liver injury can mimic all forms of acute and chronic hepatic
disease and remains a leading cause of drug failures and withdrawals from the
market. An estimated 30 percent of all adults have fatty liver disease, which
can impair normal liver function and is believed to be a cause of insulin
resistance, a component of metabolic syndrome, and a risk factor for
cardiovascular disease. A segment of these patients have advanced fibrosis or
cirrhosis, which may go undetected despite a traditional liver function test
or even a biopsy. Impaired liver function can lead to unforeseen
complications when taking drugs and interfere with the treatment of other
illnesses.
Phase II
Icoria had previously announced the award of this contract in June 2004
with an anticipation that Phase II of this contract would be worth $643,000.
After Icoria submitted the results of a successful Phase I implementation of
its "Metabolomics and Pathway Linkage: Urine, Serum, and Liver" research
program, Phase II of this contract was increased by 89% to $1.2 million.
In the initial phase, Icoria used mass spectrometry to identify individual
metabolites in urine, serum or liver based on studies of a single compound
known to cause liver damage. In Phase II, Icoria will extend the Phase I
study to include two additional liver toxicants and use analytical and data
analysis tools for metabolomics that were developed and tested during Phase I.
The results will be used for metabolomics biomarker discovery with specific
emphasis toward determining markers in urine and serum that are predictive of
liver toxicity.
"As the population ages, and as we become more dependent on long-term drug
therapies to manage chronic illnesses and extend lives, we believe the value
of diagnostics to tell physicians how a patient is reacting to these therapies
will grow," said Colatsky. "This contract will help us identify new ways to
use the liver as an important window into patient health and could lead to the
development of diagnostics that provide earlier, more reliable signals of
liver injury and help screen for these effects in the drug development
process."
"An important goal of our liver biomarker discovery program is to develop
diagnostics that can help identify patients who respond adversely to certain
treatments and to help physicians ensure that patients receive the most
appropriate medications as they progress through different stages of a chronic
illness, such as diabetes or cancer," Colatsky said.
The SBIR Phase II contract is worth up to $1,213,492 over a two-year
period. This project is funded with Federal funds from the National Institute
of Environmental Health Sciences, National Institutes of Health, Department of
Health and Human Services, under Contract No. HHSN291200555540C. The Phase I
contract was worth $99,465 and was funded by Contract No. HHSN291200445524C.
Icoria estimates that the Federal funds allocated under these contracts will
entirely support its "Metabolomics and Pathway Linkage: Urine, Serum, and
liver" research program.
In addition to the current study, Icoria's ongoing liver toxicity research
activities include programs on fatty liver disease and its relationship to
type 2 diabetes, and the interactions between changes in gene expression with
biochemical function and tissue structure. The company is also working to
characterize ADMET Technologies, Inc.'s human adult hepatocytes, to improve
their value as a predictive toxicology screening tool in the early stages of
drug development.
About Icoria
Icoria, Inc. is a biotechnology company focused on the discovery of novel,
multi-parameter biomarkers using its unique multi-platform approach. Icoria
intends to use these future biomarkers internally to develop multi-analyte
diagnostics to define and grade pathology or disease state with a high level
of specificity and sensitivity, and use its technology to help collaborators
and customers develop better, safer drugs and diagnostics and to identify
targets, leads and drug/diagnostic combinations for liver injury, metabolic
disorders and cancer. Icoria's shares trade on the over the counter bulletin
board.
This press release contains forward-looking statements including, but not
limited to, the Company's expectations for its healthcare based business model
and its biomarker discovery platform. Such forward-looking statements are
based on management's current expectations and are subject to a number of
risks, factors and uncertainties that may cause actual results, events and
performance to differ materially from those referred to in the forward-looking
statements. These risks, factors and uncertainties include, but are not
limited to, Icoria's ability to identify biomarkers, early stage of
development, history of net losses, technological and product development
uncertainties, reliance on research collaborations, uncertainty of additional
funding and ability to protect its patents and proprietary rights. Certain of
these and other risks are identified in Icoria's Quarterly Reports on Form 10-
Q for the period ended June 30, 2005, March 31, 2005, as amended, and its
Annual Report on Form 10-K for the year ended December 31, 2004, both as filed
with the Securities and Exchange Commission. The Company does not intend to
update any of the forward-looking statements after the date of this release to
conform these statements to actual results or to changes in our expectations,
except as may be required by law.
SOURCE Icoria, Inc.
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Related links:
http://www.icoria.com
CONTACT:
Media - Public Relations of Icoria, Inc.,
+1-919-425-2999
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