Navigation Links
CeNeRx Initiates Phase II Trial of TriRima™ as Monotherapy in Treatment Resistant Depression
Date:1/6/2011

RESEARCH TRIANGLE PARK, N.C., Jan. 6, 2011 /PRNewswire/ -- CeNeRx BioPharma, Inc., today reported that it has initiated a Phase II trial of its new formulation of TriRima™, the company's novel antidepressant in development as monotherapy for treatment resistant depression.  CeNeRx also announced that it will be presenting at Biotech Showcase™ 2011 on Tuesday, January 11, 2011 at 11:00 AM PST.

TriRima is a member of a novel class of drugs known as RIMAs, or reversible and selective inhibitors of monoamine oxidase A (MAO-A).  MAO inhibitors achieve superior "triple-action" antidepressant efficacy by elevating the levels of all three of the key neurotransmitters that positively affect mood.  However, older MAO inhibitors have been limited by their potential to cause serious cardiovascular side effects when foods containing the naturally occurring substance tyramine are consumed.  

TriRima is designed to achieve the efficacy of the MAO inhibitor class while reducing or eliminating the risk of these food-associated effects.  In a recently reported "tyramine challenge" study, subjects receiving the new formulation of TriRima showed no signs of any negative effects, even after being exposed to large amounts of tyramine.  These positive results further confirmed the good safety profile demonstrated by TriRima in Phase I studies.

The Phase II trial is a double blind, placebo-controlled study designed to assess the efficacy of TriRima administered twice daily as monotherapy in patients with treatment resistant depression.  Secondary objectives include evaluating TriRima's safety and tolerability and assessing its pharmacokinetic profile.  CeNeRx expects to enroll 360 patients in the study, which is being conducted at multiple centers in the U.S.

"We are eager to test the efficacy of our promising new formulation of TriRima in treatment resistant depression, and we are delighted that our Phase II trial is now enrolling patients," said Daniel Burch, MD, Chief Medical Officer of CeNeRx.  "The new formulation of TriRima has demonstrated excellent safety in multiple studies to date, and we believe that it has the potential to become the first agent to achieve the triple action efficacy of MAO inhibitor drugs without their limiting side effects."

The modified release formulation of TriRima has major advantages over the version used in earlier studies.  In addition to displaying excellent pharmacokinetic properties, the dosing frequency has been reduced to one tablet administered once or twice daily.

"TriRima addresses a large unmet medical need -- currently a substantial proportion of patients with major depression do not receive adequate relief from their therapy," noted Barry Brand, Chief Executive Officer of CeNeRx.  "TriRima has the potential to be the first option that provides these patients superior efficacy and a good safety profile as monotherapy, and we look forward to advancing the Phase II trial in the coming year."

CeNeRx will be presenting at the Biotech Showcase 2011 meeting at 11:00 AM PST on January 11.  The conference is being held January 10-12, 2011 at the Parc 55 Wyndham, San Francisco.   More information on the meeting can be found at www.ebdgroup.com/bts/index.php.

.

About CeNeRx BioPharmaCeNeRx is a privately held clinical-stage biopharmaceutical company developing and commercializing innovative treatments for diseases of the central nervous system.  CeNeRx's most advanced compound, a reversible inhibitor of monoamine oxidase, or RIMA, is in Phase II development for treatment resistant depression.  RIMAs may have efficacy advantages over current agents for depression and are expected to have a good safety profile.  The company's CNS pipeline also includes clinical-stage hypothalamic-pituitary adrenal (HPA) axis modulators for the treatment of a variety of CNS disorders including anxiety and depression; a small molecule, orally active agent for the prevention and treatment of neuropathies and neurodegenerative disorders; and a series of selective cannabinoid compounds that have recently completed successful preclinical proof-of-concept studies for the treatment of pain, glaucoma and spasticity.  The company's investors include Perseus Soros Biopharmaceutical Fund, L Capital Partners and Pappas Ventures.  For more information, visit www.cenerx.com.Contact: GendeLLindheim BioCom PartnersBarbara Lindheim212 918 4650
'/>"/>

SOURCE CeNeRx BioPharma, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima(TM)
2. CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study
3. CeNeRx BioPharma Initiates Phase II Clinical Trial of Its Novel Antidepressant Agent Tyrima(TM)
4. CeNeRx BioPharma Obtains Rights to Novel Drug Candidate for Prevention and Treatment of Neurodegeneration Disorders
5. CeNeRx BioPharma Completes $13 Million Series C Financing
6. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
7. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
8. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
9. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
10. MedImmune Initiates Phase 2a Multi-Dose Study in Patients with Asthma
11. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2017)... 19, 2017 Global Prostate Cancer Therapeutics ... the prostate cancer therapeutics market analyzes the current ... prevalence of prostate cancer, launch of promising emerging ... of new drugs & therapeutic biological products, and ... to lesser side effects are some of the ...
(Date:4/19/2017)... DIEGO , April 19, 2017  Sorrento ... an antibody-centric, clinical-stage biopharmaceutical company developing new treatments ... announced the closing of its previously announced underwritten ... stock at a public offering price of $2.00 ... and estimated offering expenses payable by Sorrento.  The ...
(Date:4/19/2017)... , April 19, 2017  Novartis today announced ... National Heart, Lung, and Blood Institute (NHLBI) of ... 58% of patients with treatment-naïve severe aplastic anemia ... treated with eltrombopag at the initiation of and ... study evaluated three sequential treatment groups, or cohorts. ...
Breaking Medicine Technology:
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... ... its new partnership with the Home Care Association of America (HCAOA). This agreement ... Private Duty Accreditation services, as well as discounts on Accreditation University (AU) educational ...
(Date:4/28/2017)... ... , ... Beginning in 2017, Ridgecrest Herbals will be phasing out the homeopathic ... Extra Strength formula. To ensure that the effectiveness of Clear Lungs Extra Strength is ... , Removal of the homeopathic element , Adding their patented ...
(Date:4/28/2017)... ... April 28, 2017 , ... GlycoMark, Inc. ... GlycoMark test throughout the Northeast U.S. , GlycoMark is the only clinically ... GlycoMark test provides a clinically proven one- to two-week measure of hyperglycemic excursions, ...
(Date:4/28/2017)... Fairfax, VA (PRWEB) , ... April 28, 2017 , ... ... elected volunteer board members and officers for 2017-2018. The annual board election process has ... serving on a volunteer basis. , Thomas C. Dickerson, Ed.D., FACHE, succeeds Jim Hamilton, ...
(Date:4/28/2017)... ... , ... The Texas Cord Blood Bank (TCBB), a program of nonprofit biomedical ... Women’s Hospital at Renaissance in Edinburg for their outstanding efforts in collecting umbilical cord ... donate. , “Women’s Hospital at Renaissance has been a collection partner for the ...
Breaking Medicine News(10 mins):