ExonHit Therapeutics : promising data on genomic biomarkers in Alzheimer’s disease clinical trials

November 8, 2010 - Aid in the selection of a homogeneous patient population to increase chances of successful study outcomes - Identification of biomarkers to predict response to treatment or monitor efficacy - ExonHit Therapeutics (Alternext: ALEHT) announced that promising data regarding the use of blood-based genomic biomarkers in Alzheimer’s disease (AD) clinical trials were disclosed in two distinct oral presentations at the Third Conference of Clinical Trials on Alzheimer’s Disease (CTAD) from November 3rd to November 5th in Toulouse, France.
The CTAD 2010 brought together current thought leaders involved in AD clinical trials to discuss in particular new results, new drug development, and methodological items (disease modifying outcomes, biomarkers, etc…).
To date, clinical trials designed to evaluate a new treatment for Alzheimer’s disease select patients based on clinical criteria, using psychometric scales, brain imaging and measurements in
cerebrospinal fluid. AD being a complex disease with multiple clinical manifestations, clinical trial results are sometimes difficult to interpret due to the heterogeneity of the patient population. Similarly, treatment response in AD is mainly assessed using psychometric scales with results that also vary according to the rater’s experience or the patient’s disposition.
“Including the use of a simple blood-based molecular biomarker such as AclarusDx™ in Alzheimer’s disease trials may facilitate the recruitment of a more homogeneous Alzheimer patient population and thus contribute to reduce random noise in trial results, hence making it easier to evaluate a drug’s potential efficacy,” stated Professor Serge Gauthier, M.D. from McGill University in Montreal. “In addition, drawing blood from patients can be done almost anywhere and is much easier than collecting cerebrospinal fluid in an aged and fragile patient population.”
“Thanks to the development of comprehensive profiling technologies such as our SpliceArray™ platform, pharmacogenomic analysis can be applied in clinical trials to develop predictive or monitoring biomarkers that can be used to identify patients who will benefit from a treatment or to follow their response to that treatment. This is what we have done with EHT 0202, our Phase II compound in Alzheimer’s disease,” added Matthew Pando, PhD, Executive Vice President, Therapeutics of ExonHit Therapeutics... [PDF] ExonHit Therapeutics' Press Release -

ExonHit, EHT 0202 Counters Scopolamine's Detrimental Effects on Cognition in Humans

March 25, 2008 - ExonHit Therapeutics, a drug and diagnostic discovery company, announced the results of a Phase 1 study assessing the effects of its lead compound, EHT 0202, on scopolamine-induced brain impairments in humans. ExonHit's EHT 0202 is a compound, with a novel mechanism of action, which has shown preclinical benefits on memory and neuronal loss and is currently tested in a Phase 2 clinical trial on Alzheimer disease (AD) patients.

Scopolamine interferes with the transmission of nerve impulses by acetylcholine, a substance to which it is structurally similar, thus depressing nervous system activity. Cognitive impairment due to central cholinergic dysfunction, or scopolamine administration, is measurable through electroencephalography (EEG) changes under both nonstimulus and stimulus conditions. A number of studies indicate that EEG is a sensitive measure of acetylcholine's activity and of the induced alterations elicited by scopolamine. In addition, scopolamine-induced EEG changes have been considered as possible biomarkers for AD as the impairment acetylcholine's activity is one of the landmarks of this disease... ExonHit Therapeutics' Press Release -

ExonHit Therapeutics, Phase 2 clinical trial of its therapeutic compound, EHT 0202, in patients with Alzheimer's disease

20 December 2007 - ExonHit Therapeutics, a drug and diagnostic discovery company, announced today that it has obtained a regulatory approval to initiate a Phase 2 clinical trial of its therapeutic compound, EHT 0202, in patients with Alzheimer's disease. EHT 0202 is a compound, with a novel mechanism of action, which has shown benefits on memory and neuronal loss... ExonHit's Press Release -

EXONHIT , A PROTOTYPE TO DETECT ALZHEIMER'S DISEASE FROM BLOOD

November 8, 2007 - ExonHit Therapeutics, a drug and diagnostic discovery company, has completed a prototype of the first blood-based Alzheimer's disease test. The company expects to have this test certified and to provide it as a service in its GLP (Good Laboratory Practices) compliant laboratories to the pharmaceutical industry as early as 2009... ExonHit's Press Release - Communiqué de Presse ExonHit -