RESEARCH TRIANGLE PARK — Paradigm Genetics received a double dose of good news in one contract on Monday.
The biotechnology firm received a Phase 1/II contract from the National Institutes of Health to purse a means of detecting biochemicals in urine, serum and liver tissue that predict early onset of liver damage.
The NIT contract, which is worth as much as $742,000 over the next 2 ½ years, also is a “fast track” award which means the NIH could accelerate approval of Paradigm developments.
Also on Monday, Paradigm said it presented data at the Symposium of the Society of Toxicologic Pathology last week that documented how its automated pathology software “could automatically distinguish between normal and diseased liver tissue.”
The NIH grant is titled “Metabolomics and Pathway Linkage: Urine, Serum and Liver”, and Paradigm will pursue preclinical studies on three compounds that cause liver damage. Paradigm will measure changes in biochemicals that “may be linked to liver toxicity,” the company said. “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.”
Paradigm added that technology gained through the acquisition of TissueInformatics would be useful in discovering so-called biomarkers for use in drug development and improving predictability of results.
Researchers from the University of North Carolina at Chapel Hill are also involved.
“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,” said Thomas Colatsky, vice president of human health research at Paradigm. “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.”
At the pathology conference, Paradigm said its tests showed that software can enhance a pathologist’s interpretation of tissue by “accurately and consistently identifying tissue features.”
“These findings demonstrate that Paradigm Genetics’ automated pathology software is readily able to detect tissue changes from normality as well as identify and provide quantitative histological biomarkers of drug-induced liver damage,” said Peter Johnson, Paradigm’s chief medical officer.