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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

BOSTON, April 2, 2008 /PRNewswire/ -- EnVivo Pharmaceuticals announced today that it has initiated a clinical safety and biomarker study of its alpha-7 nicotinic agonist (EVP-6124) in Schizophrenia patients chronically treated with atypical antipsychotic medications. The objectives of this study are to evaluate the safety of multiple doses of EVP-6124 in this patient population, to investigate potential drug-drug interactions, and to determine the effects of EVP-6124 on sensitive electrophysiology markers (the P50 auditory evoked response and mismatch negativity) in Schizophrenia patients.

The principle investigator is Dr. Sheldon H. Preskorn and the study is being conducted at the Clinical Research Institute (CRI) in Wichita, Kansas. Dr. Preskorn is Chief Executive Officer and Medical Director of the CRI which specializes in early clinical pharmacology studies in patients with psychiatric and neurologic diseases. Dr. Preskorn is also a Professor in the Department of Psychiatry and Behavioral Sciences at the Kansas University of School of Medicine - Wichita.

This trial is enrolling approximately 20 Schizophrenia patients treated with a stable dose of an atypical antipsychotic drug. Patients are receiving one of two doses of EVP-6124 or a placebo for up to 28 days. Previous Phase I studies have characterized the safety and cognitive effects of single and multiple EVP-6124 doses as low as 0.1 mg/day. Based on these studies, two doses of EVP-6124 within the expected efficacy range are being examined in this ongoing study. The results of this safety and biomarker trial will be used to design larger Phase II studies of EVP-6124 in patients with Schizophrenia. These trials will be initiated later in 2008 or in early 2009.

"Our extensive Phase I work has paid off," remarked Kees Been, President and CEO of EnVivo. "We already have results that suggest that EVP-6124 is associated with cognitive benefits in learning and memory and we believe we und
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SOURCE EnVivo Pharmaceuticals
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