Posted by: Thixia | June 14, 2008

Studies to Develop MS Diagnostics

DioGenix Discovers Gene Sets Which Correlate to Multiple Sclerosis


Will Conduct Follow-On Studies to Develop MS Diagnostics


June 09, 2008 01:23 PM Eastern Daylight Time 





Ore Pharmaceuticals Inc. (NASDAQ:ORXED) announced today that DioGenix, its molecular diagnostics subsidiary, has identified novel sets of genes that it believes will form the basis of a new assay to diagnose multiple sclerosis (MS), a disease of the central nervous system (CNS). DioGenix plans to refine these gene sets and further confirm their disease association before it begins to develop an effective commercial assay for diagnosing patients presenting with early symptoms of MS. The Company is seeking strategic alternatives to fund DioGenix’s product development efforts.


To discover these correlative gene sets, DioGenix scientists compared gene expression profiles from a genome-wide analysis of whole blood samples from MS patients, patients with alternative diseases which mimic MS and samples collected from normal donors. The scientists found statistically significant differences in gene expression between the groups, resulting in a novel gene set now covered by the Company’s recent international patent filing. This work confirmed the results of an earlier DioGenix study, based on peripheral blood mononuclear cells, announced in an October 2007 press release.


“This most recent study continues to provide encouraging evidence that we are on the right path to develop a clinically relevant diagnostic for MS,” said Larry Tiffany, Chief Executive of DioGenix. “A blood-based test that can diagnose MS would improve the quality of care for patients who currently must endure a lengthy, costly and invasive medical work-up, even in those cases where MS cannot be definitively diagnosed. This is the first phase of our MS program, as we build on our knowledgebase of MS disease biology and work to find markers that can monitor disease activity, identify sub-types of MS, and assess therapeutic activity.”


MS is a chronic inflammatory disease that selectively destroys the myelin sheaths of neurons within the CNS, leading to loss of neurological function with unpredictable course and severity. In the There are an estimated 2.5 million people with MS Worldwide.  The United States alone, the disease affects approximately 400,000 persons and up to 25,000 new cases are diagnosed each year. Susceptibility to MS is determined by genetic and environmental factors that are not well understood. Current methods of diagnosis require a battery of expensive and, in many cases, invasive tests — including lumbar puncture to access cerebral spinal fluid — that often do not result in an accurate diagnosis.


About DioGenix


DioGenix, Inc., a wholly owned subsidiary of Ore Pharmaceuticals, is a molecular diagnostics enterprise focused on the development and commercialization of novel non-invasive diagnostic, prognostic and treatment response monitoring tests. DioGenix was formed to leverage the significant capital and human resources invested by Gene Logic in the development of a unique set of assets and capabilities. For the past ten years, the DioGenix management team has been working with the world’s largest pharmaceutical companies to identify and exploit biomarkers that correlate with disease activity and therapeutic response, primarily utilizing the tools that are now core assets of DioGenix. Over this period, these assets and the well-established methods for their use have been optimized to a performance level and quality required for diagnostic, as well as pharmaceutical, development. The DioGenix team’s efforts have led to identification of a number of opportunities with significant market appeal that could be developed on an accelerated schedule. DioGenix’s lead program is designed, for the first time, to provide neurologists with a comprehensive set of clinical tests to diagnose early-stage MS, segment MS patients into clinical sub-types and predict response to treatment, all using non-invasive blood tests. Over time, DioGenix plans to utilize its unique assets and capabilities to develop additional tests for indications of significant clinical relevance.



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