- Approval Further Validates Paradigm's Metabolomics Strategy -
RESEARCH TRIANGLE PARK, N.C., June 21 /PRNewswire-FirstCall/ -- Paradigm
Genetics, Inc. (Nasdaq: PDGM), a biotechnology company, announced today that
it has received a Small Business Innovation Research Phase I/II contract from
the National Institute of Environmental Health Sciences, National Institutes
of Health, entitled "Metabolomics and Pathway Linkage: Urine, Serum, and
Liver." The Fast Track contract will support Paradigm's efforts to discover
biochemicals in urine, serum and liver tissue that predict the early onset of
drug-induced liver injury. "Fast Track" refers to a mechanism used by the NIH
to expedite the decision and award of applications that have a high potential
for commercialization.
Under the award, Paradigm will conduct preclinical studies on three
compounds known to cause liver damage, using mass spectrometry to measure
changes in hundreds of small molecular weight biochemicals that may be linked
to liver toxicity. These findings could lead to the development of diagnostics
that provide earlier, more reliable signals of liver injury and would help to
screen more consistently for these effects in the drug development process. In
addition, these types of diagnostics would have application in identifying
those patients who respond adversely to certain treatments and may help
physicians ensure that patients receive the most appropriate medications for
particular diseases.
Thomas J. Colatsky, Ph.D., Vice President of Human Health Research at
Paradigm Genetics, commented, "Currently, liver injury is not detected until
the liver is severely damaged. Paradigm's objective through this study is to
identify non-invasive biomarkers that are more sensitive predictors of the
early onset of liver injury. These biomarkers may be useful as diagnostics
that will help pharmaceutical companies to better assess drug candidate
safety. This research represents an important part of our broader commitment
to finding biomarkers for disease and drug action that will streamline drug
trials, stratify patient populations and eventually enable physicians to more
effectively diagnose and treat disease."
The importance of biomarkers has been highlighted by the Food and Drug
Administration (FDA), which issued a March 2004 report outlining the
importance of biomarkers in the drug development process for enhancing
predictability and improving clinical trial efficiency. Paradigm's biomarker
discovery program is focused on developing integrated suites of biomarkers
that can be used to predict, diagnose and monitor drug and chemical-induced
toxicity more reliably than currently used measurements. The Company's
acquisition of TissueInformatics, Inc. provides Paradigm with well-validated
technologies for obtaining quantitative tissue information for use in
Paradigm's biomarker discovery efforts. This competitive advantage positions
Paradigm at the forefront of biomarker discovery research.
The fast-track contract is worth up to $742,000, with $99,000 funded for
the six-month Phase I part of the study and an additional $643,000 over two
years for Phase II, upon the successful completion of Phase I. This project
has been funded in whole or in part with Federal funds from the National
Institute of Environmental Health Sciences, National Institutes of Health,
Department of Health and Human Services, under Contract No. HHSN291200445524C.
In addition to the current study, Paradigm's liver toxicity research
activities include a collaboration with the University of North Carolina at
Chapel Hill to identify biomarkers indicative of choline deficiency, a
physiological state that has been implicated in the onset of liver damage in
humans. Also, the Company is working with UNC-CH, the National Institute of
Environmental Health Science (NIEHS) and NIH to determine the underlying
mechanisms by which acetaminophen causes liver toxicity.
About Paradigm Genetics
Paradigm Genetics is a biotechnology company applying its proprietary
systems biology platform to the discovery of safer, more effective drugs and
agrichemicals. Paradigm Genetics has major collaborations with the National
Institute of Environmental Health Sciences, Bayer CropScience, the Monsanto
Company, Pioneer Hi-Bred International, the National Institute of Standards &
Technology's Advanced Technology Program, and L'Oreal Inc. For more
information, visit http://www.ParadigmGenetics.com .
This press release contains forward-looking statements, including
statements regarding the Company's expectations for using its systems biology
platform to discover safer, more effective drugs and agrichemicals. 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, Paradigm's 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 Paradigm's annual report on Form 10-K
for the year ended December 31, 2003 and in its quarterly report on Form 10-Q
for the quarter ended March 31, 2004, each 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 Paradigm Genetics, Inc.
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http://www.paradigmgenetics.com
CONTACT:
Brian Ritchie or Mark Vincent of EURO RSCG
Life NRP, +1-212-845-4200
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