Reference: PD 10023
The Problem
Interferon (IFN) therapy, the conventional treatment for Hepatitis C (Hep C), presents with several drawbacks. These drawbacks include a long treatment trial to determine patient response to IFN, inefficiency in a significant number of patients, and significant side effects. The response rate to IFN therapy is approximately 19%, and 25-40% with the PEGylated form of IFN. The average response rate with the IFN and ribavirin combination therapy is approximately 50%. In African Americans the IFN response rate is even less, as evidenced by the current study (see table below). A diagnostic test to determine the possibility of clinical success with IFN therapy would be of great clinical value.
The Technology Solution
Researchers at the University of Tennessee Health Science Center (UTHSC) have developed a diagnostic method for predicting whether a Hep C patient will respond to IFN therapy. An IFN signature gene list of 39 genes was established based on microarray analysis and bioinformatics search of IFN stimulated genes (ISG). The researchers examined the expression of the ISG signature in 130 samples of FFPE tissue from liver biopsies obtained prior to therapy in patients whose clinical course and response to IFN therapy were subsequently well-characterized. Of the 39 genes, 11 of them proved to be highly significant in terms of the level of gene expression in responders compared to expression in non-responders (see data plot of representative gene). This gene signature test may have important predictive value to identify patients who most likely will fail to respond to conventional IFN therapy. With the emergence of new Hep C therapies, this type of test will be valuable in determining whether a patient should receive new lines of therapy instead of IFN.
Benefits
• New emerging Hep C therapies create market for this technology.
• This technology creates value for companies developing new Hep C therapies.
• Can identify IFN non-responders early.
• Can determine proper treatment regimen before starting treatment.
• Can eliminate long period of IFN therapy to which patient does not respond.
Patents
• PCT Patent Application PCT/US2011/056063- Filed October 2011
The Inventors
Dr. Lawrence Pfeffer is Muirhead Professor in the Department of Pathology at the UTHSC. His research interests center on an understanding of the cellular and molecular mechanisms of interferon action in cancer and viral disease. The co-inventor of this technology is Dr. Charles Handorf who is chairman of Pathology at UTHSC. His research interests include tissue banking, virtual microscopy, and development of strategies for diagnosis of cancer of unknown primary origin.