This CE marking will enable ExonHit, from April 2011 on, to put AclarusDx™ at the disposal of Memory Centers, especially expert Memory Centers. ExonHit will set up, in 2011, in close collaboration with the major Alzheimer's key opinion leaders, a study in real clinical setting in order to collect “real life” data allowing to further position AclarusDx™ within the diagnostic algorithm currently used by Memory Centers to diagnose AD.
"We are proud to be able to offer AclarusDx™ to Memory Centers in France and to allow neurologists and geriatricians of these centers to test AclarusDx™ in patients undergoing clinical diagnosis. This collaboration with the French AD experts is essential to understand the role that AclarusDx™ could play in the early diagnosis of the disease," said Loïc Maurel, M.D., President of the Management Board of ExonHit Therapeutics.
AclarusDx™ is being utilized since the end of 2009 in clinical research. It is part of the MAPT (Multidomain Alzheimer Preventive Trial) study whose main objectives are to assess, over 3 years, the comparative efficacy of a pharmacological intervention (omega-3 fatty acid supplement), a “multidomain” intervention (nutrition, physical exercise, cognitive stimulation, and social activities), or their association on the evolution of the cognitive functions in frail individuals aged 70 or more. ExonHit is associated with Toulouse University Hospital, the trial sponsor, and The Institut de Recherche Pierre Fabre in order to evaluate the interest of AclarusDx™, and potentially other transcriptomic signatures, in the early identification of aged frail subjects progressing to Alzheimer’s disease (1).
About AclarusDx™ AclarusDx™ is a blood-based test intended to help in the diagnosis of Alzheimer’s disease (AD). This test is based on the compared analysis of AD patients’ transcriptome with that of healthy subjects. It was developed by identifying a signature gathering biomarkers linked to more than 130 genes including some particularly involved in inflammatory and immune mechanisms observed in AD. A French multicenter blind validation study involving 164 individuals, helped to establish the assay performance: a sensitivity of 81% and a specificity of 67% (2).
About Alzheimer’s disease in France Alzheimer's disease is a neurodegenerative disease which, with related syndromes, affects more than 225,000 new patients each year. The last estimates state that approximately 855,000 patients are suffering from AD and related diseases (3). This disease, for which the certainty of the diagnosis can only be obtained post-mortem, is the leading cause of dependency. Approved treatments for the disease are symptomatic and, according to a recent assessment from the National Institute for Clinical Evidence could delay the loss of independence if they were prescribed early enough (4).
About ExonHit Therapeutics ExonHit Therapeutics (Alternext: ALEHT) is a fast emerging healthcare player active in both therapeutics and diagnostics. The Company is applying its proprietary technology, based on the analysis of alternative RNA splicing, to develop innovative molecular diagnostic tests and therapeutics for neurodegenerative and cancer indications. ExonHit has a balanced investment strategy with internal development programs and strategic collaborations, in particular with Allergan and bioMérieux.
ExonHit is headquartered in Paris, France and has U.S. offices in Gaithersburg, Maryland. The Company is listed on Alternext of NYSE Euronext Paris. For more information, please visit http://www.exonhit.com.
Disclaimer This press release contains elements that are not historical facts including, without limitation, certain statements on future expectations and other forward-looking statements. Such statements are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.
In addition, ExonHit Therapeutics, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.
Finally, this press release may be drafted in the French and English languages. In an event of differences between the texts, the French language version shall prevail.
References (1) http://www.exonhit.com/sites/default/files/PR_MAPT_Nov_2009_FR.pdf. (2) In house data (3) Gallez report, OPEPS, July 2005 (4) http://www.nice.org.uk/nicemedia/live/12248/52515/52515.pdf
Contact:
Media & Investors Corinne Hoff +33 1 58 05 47 04 corinne.hoff@exonhit.com
