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EnVivo Pharmaceuticals Announces Initiation of Clinical Safety and Biomarker Study of Alpha-7 Nicotinic Agonist, EVP-6124, in Patients with Schizophrenia
Date:4/2/2008

erstand the dosing range in which to expect efficacy. This significantly enhances the probability of success of the upcoming biomarker and Phase II studies."

About Electrophysiological Biomarkers in Schizophrenia Patients

Patients with Schizophrenia invariably have abnormalities in sensory gating thought to be responsive to alpha-7 nicotinic receptor stimulation. When repetitive auditory stimuli are presented to a patient with Schizophrenia, the evoked electrophysiologic brain response (the P50 response measured 50 msec after each stimulus) in such patients is abnormal. Normal individuals suppress this response by up to 80% while patients with Schizophrenia have decreased ability to suppress the response to a second stimulus. Sensory gating abnormalities in Schizophrenia have been linked to an allele on chromosome 15, the gene locus for the alpha-7 receptor. Alpha-7 nicotinic agonists have been recently shown to improve cognition and the P50 response in patients with Schizophrenia. Thus, the P50 response may be a sensitive biomarker for assessing the pro-cognitive effect of an alpha-7 nicotinic agonist in Schizophrenia.

Mismatch negativity is another electrophysiological biomarker that has been shown to be abnormal in patients with Schizophrenia. Mismatch negativity is assessed by the ability of the patient to detect a unique stimulus imbedded in a repetitive train of otherwise identical auditory stimuli. Assessments of the effects of EVP-6124 on the P50 evoked response and mismatch negativity may be very useful in determining the threshold and optimal dose of EVP-6124 for further development.

About EVP-6124

EVP-6124 is a potent full agonist of the alpha-7 nicotinic receptor. This drug candidate has been shown to have excellent CNS penetration, oral bioavailability, pharmacokinetics, and metabolic profile. In multiple preclinical animal models of cognition, EVP-6124 has had significant beneficial effects.

About EnVivo Pharma
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SOURCE EnVivo Pharmaceuticals
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