|>>RESEARCH TRIANGLE PARK, N.C., June 21 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), 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.<<