Navigation Links
Marinus Pharmaceuticals Announces Commencement of Phase 2 Trial of Ganaxolone for the Treatment of Posttraumatic Stress Disorder
Date:4/21/2011

BRANFORD, Conn., April 21, 2011 /PRNewswire/ -- Marinus Pharmaceuticals, Inc., the leader in the development of neurosteroids for central nervous system disorders, today announced commencement of a proof-of-concept clinical trial of its lead candidate ganaxolone for the treatment of posttraumatic stress disorder (PTSD). Ganaxolone modulates inhibitory GABA-A receptors, possibly at a specific neurosteroid recognition site. Neurosteroid levels have been implicated in both the severity and treatment outcome in PTSD patients.

"This trial will test the hypothesis that a neurosteroid analog of allopregnanolone will be beneficial in the treatment of PTSD and augment our existing safety database for ganaxolone in humans," stated Gail Farfel, Ph.D., Chief Development and Regulatory Officer of Marinus. "Achieving full remission of PTSD symptoms is difficult with current treatments for PTSD.  New options that can increase efficacy are needed for the growing population of PTSD patients worldwide."

This randomized, double-blind, placebo-controlled clinical trial is being conducted by the INTRuST Consortium to evaluate the safety, tolerability and efficacy of oral ganaxolone after six weeks of dosing in patients with PTSD. The INTRuST Consortium is a group of clinical study centers in the United States funded by a Department of Defense award to advance treatments and medical research in PTSD and traumatic brain injury. This public-private collaboration will study ganaxolone under Marinus' Investigational New Drug Application (IND) filed with the Food and Drug Administration (FDA). The trial will take place in the United States and is designed to enroll approximately 120 PTSD patients.

"Ganaxolone has been shown in clinical studies to be efficacious and well tolerated in refractory epilepsy patients, and we expect the INTRuST PTSD trial to expand ganaxolone's profile into neurosteroid-mediated psychiatric disorders," said Kenneth Shaw Ph.D., Senior Vice President, R&D of Marinus. "We are pleased that the INTRuST Consortium is conducting this trial and await the results expected in 2012".

About Ganaxolone

Ganaxolone is a synthetic neurosteroid and a derivative of the naturally occurring neuromodulator, allopregnanolone.  Ganaxolone has been administered to more than 950 healthy adult volunteers and patients in Phase 1 and Phase 2 studies. Completed Phase II epilepsy studies have generated data supportive of the efficacy and safety of ganaxolone in the treatment of both children and adults suffering from refractory epilepsy (patients who continue to have seizures despite taking multiple anticonvulsant drugs). Scientific research has suggested that ganaxolone therapy may be useful in the treatment of several other central nervous system disorders including posttraumatic stress disorder (PTSD) and Fragile-X syndrome (FXS). Ganaxolone is being developed as a first in class treatment in epilepsy, PTSD and FXS.

Marinus has successfully developed several proprietary and novel patented formulations of ganaxolone.

About Posttraumatic Stress Disorder (PTSD)

PTSD is a severe anxiety disorder that can develop after exposure to a traumatic event, overwhelming the individual's ability to cope. As an effect of psychological trauma, PTSD is less frequent and more enduring than the more commonly seen acute stress response.

Diagnostic symptoms for PTSD include re-experiencing the original trauma(s) through flashbacks or nightmares, avoidance of stimuli associated with the trauma, and increased arousal – such as difficulty falling or staying asleep, anger and hyper-vigilance. PTSD symptoms cause significant impairment in social, occupational or other important areas of functioning.

Lifetime prevalence is at least 1% and may be as high as 15% in the U.S. population. A national comorbidity survey conducted in the early 1990s found that women are twice as likely as men to experience PTSD. In high-risk groups, such as combat veterans and victims of violent crimes, prevalence can range from 20% to over 50%.

About Marinus Pharmaceuticals

Marinus is a specialty pharmaceutical company dedicated to the reformulation, development, and commercialization of novel drugs to treat serious neurological and psychiatric disorders. Marinus is located in Branford, Connecticut. Its investors include Domain Associates, Canaan Partners, Sofinnova Ventures and Foundation Medical Partners. For additional information, please visit the company's Web site at www.marinuspharma.com.

About INTRuST

For more information on INTRuST please visit the consortium's website at http://intrust.sdsc.edu/.


'/>"/>
SOURCE Marinus Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Marinus Pharmaceuticals Issued Patent for Ganaxolone
2. Marinus Pharmaceuticals Announces U.S. Department of Defense Grant to Study Ganaxolone in Fragile-X Syndrome
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
9. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
10. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
11. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... 2022" report to their offering. ... with kidney failure, it replaces the function of kidneys by ... and thus the treatment helps to keep the patient body,s ... Increasing number of ESRD patients & substantial healthcare ...
(Date:6/23/2016)... 23, 2016 Roche (SIX: RO, ROG; OTCQX: ... its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated ... shock. With this clearance, Roche is the first IVD ... solution for sepsis risk assessment and management. ... and PCT levels in blood can aid clinicians in ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events ... turn to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. ... tools for healthy coping following a traumatic event. , Trauma sufferers tend to feel ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... ... 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited to ... Recovery® program to drive cancer patients to and from their cancer treatments. Comfort ... quality of life and ongoing independence. Getting to and from medical treatments is ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... People across ... in Genome magazine’s Code Talker Award, an essay contest in which patients and their ... award to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual ...
Breaking Medicine News(10 mins):