Navigation Links
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 understand 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 Pharmaceuticals

EnVivo Pharmaceuticals (located in Watertown, MA) is a biopharmaceutical company dedicated to discovering and developing small molecule therapeutics for disorders of the central nervous system (CNS), currently focusing on Alzheimer's disease, Parkinson's disease, Huntington's disease, and cognition. The company's lead program, an Alpha-7 Nicotinic Acetylcholine receptor agonist for cognition disorders in Alzheimer's disease and Schizophrenia, will be entering additional trials in both indications this year. The company's advanced pre-clinical program, a Histone Deacetylase inhibitor (HDACi) for Huntington's disease is scheduled for clinical entry later in 2008. The company's other preclinical programs include a Gamma Secretase Modulator and a PDE10 inhibitor. For more information about EnVivo, please visit http://www.envivopharma.com.


'/>"/>
SOURCE EnVivo Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. EnVivo Pharmaceuticals Announces Progress on Major Drug Programs Focusing on Alzheimers, Schizophrenia and Huntingtons Diseases
2. ISTA Pharmaceuticals Announces Results of Clinical Trial of Xibrom(TM) QD (Once-Daily) Formulation
3. Monogram Biosciences Provides Progenics Pharmaceuticals with HIV Assays for Use in Clinical Trials
4. Keryx Biopharmaceuticals Announces Termination of SUN-MACRO Phase 4 Trial
5. Poniard Pharmaceuticals Announces Commercial Manufacturing Agreement With W. C. Heraeus GmbH for Picoplatin
6. Rexinoid Developed by NuRx Pharmaceuticals Shows Promise in Prevention, Treatment of Lung, Breast Cancer, Paper in Clinical Cancer Research Reports
7. Anacor Pharmaceuticals Announces Positive Results from Phase 2a Clinical Trial of AN2728 in Psoriasis Patients
8. NuRx Pharmaceuticals Doses First Patient in Phase I Clinical Trial of First-in-Class RXR Agonist NRX4204
9. MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate
10. VIA Pharmaceuticals Completes Enrollment In Phase 2 Carotid Endarterectomy (CEA) Trial
11. Poniard Pharmaceuticals Announces Clinical Data From Picoplatin Oral Phase 1 to Be Presented at the American Association of Cancer Research Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... 2016   Acsis , a leading provider of ... market research and advisory firm IDC has named it ... Worldwide Pharmaceutical Track and Trace Software 2016 Vendor Assessment ... assessment of the capabilities and business strategies of 10 ... Logo - http://photos.prnewswire.com/prnh/20160427/360791LOGO ...
(Date:4/28/2016)... April 28, 2016 New ... 2016" is a report that provides an overview ... R&D pipelines by identifying new targets and MOAs ... Company Profiles discussed in this H1 2016 Osteoarthritis ... Srl, AbbVie Inc., Abiogen Pharma S.p.A., Ablynx NV, ...
(Date:4/27/2016)... Avril 2016   ... +5% sur le trimestre, soutenu par une croissance ... Croissance de +16% des ventes aux hôpitaux ... Kea Technologies (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), inventeur ... aujourd,hui son chiffre d,affaires pour le premier trimestre ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... Our bodies are bombarded daily by environmental and ... with these stressors is to adopt a more healthful diet, but too many people ... a certified Holistic Nutritionist and the creator of the Newport Beach Cleanse and 14-Day ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... of our nation’s productivity, stability, even security. Most importantly, employees are the single ... Then why are American workers so unhappy? , Just under half of American ...
(Date:4/29/2016)... VA (PRWEB) , ... April 29, 2016 , ... ... with student loans more flexibility in repaying their loans, more information about their ... a time when total outstanding student loan debt, including federal and private loans, ...
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart ... at its new location in the Exchange Furniture Mall at 112 Vilseck Road in ... 50-inch Samsung Smart TV. Plus attendees will have the opportunity to meet general dentists ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... Spine Team ... pain, is proud to announce one of their physicians has been invited to be ... Physicians (Texas ACOFP) Family Practice Review conference on April 30, 2016. , Dr. ...
Breaking Medicine News(10 mins):