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Exonhit Aims To Ask For Market Clearance For Blood Diagnostic Test For Alzheimer's Disease

Armen Hareyan's picture

ExonHit Therapeutics will ask for certification in Europe, and for market clearance in the USA, as early as 2009 for a multi-gene expression test assisted by an algorithm to produce a score that determines whether the patient is deemed with Alzheimer's disease.

Certification of a diagnostic test requires proving that the test can achieve what it has been designed to achieve. The certification program defined by ExonHit aims at proving that the test can differentiate Alzheimer's disease from other pathologies such as fronto-temporal dementia, dementia with Lewy bodies, vascular dementia, and even dementia associated with Parkinson's Disease or other disorders that are associated with "reversible" dementia including depression, medication-induced dementia, hypothyroidism, B12 deficiency and systemic infections. To that end, ExonHit is engaged in a large clinical program to collect blood samples to ascertain the specificity of its diagnostic test.

ExonHit has already established that its blood-based AD diagnostic test distinguishes individuals with Alzheimer's disease as judged by a MMSE (Mini Mental State Examination) score below 20 and a GDS (Global Deterioration Scale) score above or equal to 4, from individuals with no cognitive losses. It is this positioning that ExonHit is now targeting in its marketing efforts.

The additional scientific data, which has been obtained in the framework of the ongoing certification clinical program and which are presented at the "BioMarkers for Alzheimer's disease" meeting in Washington DC, on June 7-8 2007, confirm that one can isolate, from blood, RNA biomarkers which are associated with AD and highlight the work which is being carried out to evaluate the test's specificity. The first set of biomarkers identified by ExonHit, and published in March 2007, was established using blood samples from a control group of non-AD patients which included patients suffering from cardiovascular or metabolic disorders such as hypertension, coronary obstruction, type II diabetes, dyslipidemia. Using another control group of non-AD patients with little to no such disorders significantly improved the test's ability to identify the AD patients.

"These results are consistent with the epidemiology and the functional alterations associated with both cardiovascular disorders and AD-related cognitive impairments. Our test will concern primarily aged patients. It is of course essential to take in account additional pathologies that occur in this aged population in order to optimize the diagnostic. To this end, several hundreds of new blood samples will to better define the test's specificity" declared Laurent Bracco, Executive Vice-President for Research at ExonHit.

Once the clinical validations are finalized following ExonHit's protocoles, , ExonHit will seek certification of the test in Europe (i) to first market its AD test directly to pharmaceutical companies wishing to include a quantitative biological test in the patient recruitment protocols of their clinical trials in AD for new or existing drugs, and (ii) to then license the commercial rights for use of its AD test rights by the general medical community to one or more in vitro diagnostic companies.

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Over 150 clinical trials for AD drugs are realized every year and the pharmaceutical industry is looking for quantitative biological tests enabling the recruitment of homogenous patient groups. ExonHit's AD test is being developed to fit that specific need, moreover, it could also be used for AD screening in the aged population. There are about 28 million AD patients world wide with 4.5 million in the USA and 7 million in Europe.

"A blood diagnostic for AD patients would be a very informative and useful step towards the ultimate goal which is the early detection of this debilitating pathology" stated Dr Laurence Hugonot-Diener, geriatric specialist at Rothschild Hospital in Paris.

"We have conducted market analysis confirming the pharmaceutical industry's need for certified blood detection kits for Alzheimer disease. Our objective is to rapidly have this test certified in Europe and to license it to an in vitro diagnostic company while retaining some marketing rights to assist the pharmaceutical industry with the recruitment of AD patients for clinical trials." commented Bruno Tocque President of the Management Board of ExonHit. He added "We have the financial resources needed to implement this strategy and to obtain the licenses which may be required for the commercialisation of this test."

Initially thought of as mainly neuronal, Alzheimer's disease is now better understood and is thought to be caused by alterations in the three main biological systems which ensure the body's homeostasis: the nervous, endocrine and immune system. Hence, alterations of certain neurons lead to modifications in endocrine regulation. This in turn, impacts the activity and viability of other neurons and the function of the immune system. Alteration in the immune response also plays a key role in the development of Alzheimer's disease. As a result of this better understanding of the disease and ExonHit's expertise, it is now potentially possible to measure the various stages of Alzheimer's disease by examining cells circulating in the blood.

ExonHit Therapeutics is the world's leader in the analysis of alternative RNA splicing, a process which when deregulated plays a key role in the onset of various diseases.

ExonHit has a multi-component commercial strategy to capture the maximum value from its leadership in alternative splicing. The Company is already generating revenues from a new generation of microarrays, SpliceArrayTM family of products that enable life science researchers to detect crucial disease-associated information. These products are marketed worldwide in conjunction with Agilent and Affymetrix. In the field of diagnostics, ExonHit has a major collaboration with bioMerieux to develop completely novel predictive blood-based cancer diagnostics, which could play a key role in improving the treatment of breast cancer and other major cancers and develops its own projects for the detection of other chronic diseases such as Alzheimer'disease or atherosclerosis.

In parallel, ExonHit is developing its own therapeutic pipeline in the field of neurodegenerative diseases and cancer. The Company has advanced drug candidates into clinical trials and is evaluating several promising pre-clinical compounds. ExonHit also has a strategic partnership with Allergan, to discover and develop new therapeutics in the areas of pain, neurological diseases and ophthalmology. This collaboration provides on-going research funding to ExonHit.