Navigation Links
Naurex Inc. Initiates Phase I Clinical Trial of its Novel Mechanism NMDA Modulator GLYX-13 in Treatment-Resistant Depression
Date:12/16/2009

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 www.clinicaltrials.gov .

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.




    Contacts:
    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:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in Bogota. Colombia ... ... Sandra ... ... Astellas is a pharmaceutical company ...
(Date:6/23/2016)... FRANKLIN, Tenn. , June 23, 2016 ... for automating, integrating and transforming the patient ... launch of several innovative new products and ... depth of its revenue cycle offerings. These ... establish more efficient workflows, remain compliant in ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 2016 , ... A revolution is underway. Brooklyn-based company, ... for the millions of people who require these medical transport services annually. ... the use of technology. Now, SmartEMS has put forth an industry-changing app that ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on ... Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ability ... fumigation is not a common occurrence, but a necessary one in the event that lice ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
Breaking Medicine News(10 mins):