Navigation Links
Naurex Inc. Initiates Phase I Clinical Trial of its Novel Mechanism NMDA Modulator GLYX-13 in Treatment-Resistant Depression

EVANSTON, Ill., Dec. 16 /PRNewswire/ -- Naurex Inc., a new clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel GFPA NMDA receptor modulators, today announced that it has initiated a Phase I clinical trial of its lead compound GLYX-13 and has successfully dosed the first subjects in the study. GLYX-13, a glycine site functional partial agonist (GFPA) selective modulator of the NMDA receptor, is initially being developed as a therapy for treatment-resistant depression in severely depressed patients admitted to the hospital. Separately, Naurex announced that data presented at a recent medical meeting reported that GLYX-13 demonstrated robust antidepressant-like and anxiolytic-like activity in animal models with no signs of the CNS-related side effects observed with other drugs targeting the NMDA receptor. The studies also showed that the antidepressant effects of GLYX-13 were evident within 20 minutes and demonstrated a lasting antidepressant effect of greater than four days after administration of a single dose. In these studies, GLYX-13 affected both the positive and negative symptoms of depression.

"Based on its demonstrated safety and antidepressant-like activity in well-validated animal models, we are pleased to have begun assessing GLYX-13 in human trials," said Ronald Burch, MD, PhD, chief medical officer at Naurex. "We are optimistic that this Phase I safety trial will pave the way for rapidly proceeding to more advanced trials in patients admitted to the hospital with severe treatment-resistant depression, a condition with an urgent need for additional treatment options."

The GLYX-13 Phase I trial is a randomized, double-blind, placebo-controlled single ascending dose level study of the safety, tolerability and pharmacokinetics of GLYX-13. The trial is currently recruiting and plans to enroll 20 healthy volunteers. The primary outcome measure is observed and laboratory-confirmed safety. Drug pharmacokinetics will also be measured.

The efficacy of NMDA receptor glycine site functional partial agonists has been demonstrated in animal models and early human studies in a number of CNS disorders, including major depressive disorder, neuropathic pain, schizophrenia, anxiety, Alzheimer's disease and other cognition disorders. In these studies, GFPA modulators did not exhibit the psychosis-like side effects associated with NMDA receptor blockers that interact with other binding sites on the receptor complex. GLYX-13 has demonstrated a wide therapeutic ratio (500:1) between efficacy and side effects, which is the largest therapeutic ratio of any reported molecule that interacts at the NMDA receptor.

For more information about the GLYX-13 Phase I trial, see .

About Naurex

Naurex, Inc. is a private company developing novel therapies for depression and other CNS disorders based on the work of founder Dr. Joseph R. Moskal and colleagues now at The Falk Center for Molecular Therapeutics at Northwestern University, who discovered a new mechanism of action for modulating the NMDA receptor. Naurex has used these discoveries to generate novel chemical drug classes known as glycine site functional partial agonists (GFPAs). Naurex's first GFPA NMDA modulator, GLYX-13, has shown promising signs of antidepressant activity with excellent safety in preclinical studies. It is currently being assessed in a Phase I clinical trial in preparation for evaluation in patients with severe treatment-resistant depression. A second generation series of compounds is advancing rapidly in preclinical development.

    Corporate       Media
    Naurex Inc.     GendeLLindheim BioCom Partners
    Derek Small     Barbara Lindheim
    Acting CEO      212 918-4650

SOURCE Naurex Inc.

SOURCE Naurex Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Naurex Inc. Announces Presentation of Preclinical Data Showing its Novel Mechanism NMDA Modulator Exhibits Robust and Rapid-Onset Antidepressant Activity With No Signs of Classic NMDA-Associated Side Effects
2. Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma
3. ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis
4. Sangart, Inc. Initiates Phase IIa Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock
5. Bayer HealthCare Pharmaceuticals Initiates Phase III Trial with Florbetaben PET Tracer for Imaging of Cerebral beta-Amyloid Plaques, a Pathological Hallmark of Alzheimers Disease
6. Proteon Initiates Second Phase 1/2 Clinical Study of PRT-201 in Hemodialysis Patients
7. Echo Therapeutics Initiates Clinical Study of its New One-Piece Symphony(TM) tCGM Biosensor in Type 1 and Type 2 Diabetic Patients
8. Incept BioSystems Initiates First Human Clinical Trial of its SMART Embryo Culture System for In Vitro Fertilization (IVF)
9. BioMarin Initiates Phase 2 Clinical Study of PEG-PAL in PKU
10. Lexicon Completes Phase 1 Clinical Trial and Initiates Phase 2 Clinical Trial of LX4211 in Patients With Type 2 Diabetes
11. LigoCyte Pharmaceuticals Initiates a Randomized, Double Blind, Placebo Controlled Norovirus Vaccine Study Including Live Virus Challenge
Post Your Comments:
(Date:12/1/2015)... India , December 1, 2015 ... market research report "Immunotherapy Drugs Market by Type of Drug ... Checkpoint Inhibitors), Epidemiology, Regulatory and Pipeline Analysis - Global Forecast ... is poised to reach USD 73,529.2 Million by 2020 from ... from 2015 to 2020. Browse 37 ...
(Date:12/1/2015)... , 1 de diciembre de 2015 /PRNewswire/ ... para cuchillas de precisión, develó hoy un ... identidad de marca. El nuevo logo destaca ... y la ingeniería de productos con cuchillas ... ...
(Date:12/1/2015)... 2015 During the recent 2015 Transcatheter ... Francisco, CA , Medinol Ltd. continued to ... During a satellite symposium, "The BioNIR eDES: The ... Restenosis", a renowned physician panel discussed the key ... Coronary Stent System and the Medinol eDES Coronary ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... ... has been selected as a finalist in this year’s Fierce Innovation Awards: Healthcare ... IT Healthcare was recognized as a finalist in the category of Digital Solutions ...
(Date:12/1/2015)... ... December 01, 2015 , ... Lutronic, a leading innovator of aesthetic and ... to the devices for sale in the United States. Clarity is a Superior ... nm Nd:YAG lasers, into a single platform that is easy to own and operate. ...
(Date:12/1/2015)... ... 01, 2015 , ... PYA’s latest white paper, “ PYA ... main “pain point” for merging or aligning healthcare provider organizations—when mergers and other ... This quick-read guidance suggests that failing to recognize the power of an ...
(Date:12/1/2015)... ... 2015 , ... PartnerTech , a leader in high-tech ... 2008. Gary Bruce, President of PartnerTech North America, currently serves as Director for ... of time in Sweden since joining PartnerTech based in Malmo, Sweden. He has ...
(Date:12/1/2015)... ... December 01, 2015 , ... Nurotron Biotechnology Co., Ltd., maker of ... to date. , The order will be from the China Disabled Persons’ Federation, ... System is an effective solution for children and adults suffering from severe and ...
Breaking Medicine News(10 mins):