Icoria Awarded $1.2 Million Liver Injury Contract From NIEHS
August 29 2005 - 9:30AM
PR Newswire (US)
RESEARCH TRIANGLE PARK, N.C., Aug. 29 /PRNewswire-FirstCall/ --
Biotechnology company Icoria, Inc. (OCT Bulletin Board: 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. DATASOURCE: Icoria,
Inc. CONTACT: Media - Public Relations of Icoria, Inc.,
+1-919-425-2999 Web site: http://www.icoria.com/
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