Navigation Links
CeNeRx BioPharma Initiates Phase II Clinical Trial of Its Novel Antidepressant Agent Tyrima(TM)

RESEARCH TRIANGLE PARK, N.C., Oct. 17 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced that it has initiated a Phase II clinical trial for its lead product candidate Tyrima(TM) for the treatment of major depressive disorder (MDD). Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A (MAO-A). The primary objective of this Phase II trial is to evaluate the antidepressant efficacy of Tyrima in patients with confirmed MDD. The trial design incorporates a number of features intended to reduce the variability and placebo response often observed in MDD clinical trials.

The randomized, double-blind, placebo-controlled Phase II trial will enroll approximately 272 patients with moderate to severe MDD who will receive either Tyrima or placebo for six weeks. The primary study objective of antidepressant efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary objectives of the study include evaluation of safety, tolerability, and pharmacokinetics of Tyrima. The trial design was supported by a Tyrima Phase I safety database of 106 subjects and a PET (positron emission tomography) study that yielded critical insight into the dose-response relationship of Tyrima. A number of patients are already randomized in the trial and initial results are expected by the end of 2009.

"Tyrima has the potential to be the first triple-action antidepressant with a safety profile appropriate for the treatment of a broad population of patients with depression, and we are committed to generating robust clinical data from this Phase Il trial," said Dr. Daniel Burch, Executive Vice President of R&D and Chief Medical Officer of CeNeRx. "We worked closely with experienced MDD clinical trial experts, disease specialists, and biostatisticians to incorporate a number of features in the study design intended to manage the issues that can confound antidepressant clinical trial results."

Depression clinical trial expert Dr. Norman Rosenthal, Medical Director of Capital Clinical Associates and one of the lead investigators of the Tyrima Phase II study noted, "The CeNeRx team gets high marks for designing a first-class clinical trial. Recent efforts to test new antidepressants have encountered technical difficulties, such as a high placebo effect, which the current trial works hard to avoid. I am optimistic that the present trial should enable us to assess the potential of Tyrima as a potentially valuable new antidepressant agent."

Similar to the mechanism of conventional monoamine oxidase A inhibitors (MAOI), the triple-action mechanism of Tyrima elevates the levels of three key neurotransmitters (serotonin, norepinephrine and dopamine) that positively affect mood and anxiety, compared to the one or two neurotransmitters addressed by most current antidepressant drugs. This triple-action mechanism has the potential to provide improved antidepressant efficacy in some patients, while the selectivity and reversibility of Tyrima are expected to reduce or eliminate the risk of food-associated cardiovascular side effects of conventional MAOIs.

"A substantial subset of patients suffering from depression responds much better to treatment with MAOIs than other therapies, yet the risk of food-associated cardiovascular side effects of conventional MAOIs have greatly restricted their use, to the disadvantage of our patients," said Dr. Alexander Bodkin, a Tyrima Phase II investigator and Director of the Clinical Psychopharmacology Research Program at McLean Hospital of Harvard Medical School. "A novel agent such as Tyrima with proven MAOI activity in the CNS and a good safety and tolerability profile would be a valuable option for the many patients whose depression is refractory to treatment with currently prescribed antidepressant drugs."

CeNeRx has worldwide rights to develop and commercialize Tyrima. This compound, which could be the first RIMA antidepressant available in the U.S. market, has patent protection beyond 2027.

About CeNeRx BioPharma

CeNeRx 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, has entered Phase II development for the treatment of major depressive disorder. RIMAs may have efficacy advantages over current agents for depression and are expected to have a good safety profile. The company is also developing its pipeline of selective cannabinoid compounds that have recently completed successful preclinical proof-of-concept studies for the treatment of pain, glaucoma and spasticity. More information about CeNeRx BioPharma can be found at


GendeLLindheim BioCom Partners

Barbara Lindheim

212 918 4650

SOURCE CeNeRx BioPharma, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study
2. CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima(TM)
3. InCode BioPharmaceutics, Inc. Announces Key Data Supporting New Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
4. XTL Biopharmaceuticals Announces Completion of Patient Randomization Into the Bicifadine Phase 2b Clinical Trial for the Treatment of Diabetic Neuropathic Pain
5. Morria Biopharmaceuticals Plc Announces the Initiation of a Phase II Clinical Multi-dose Study of MRX-4 in Allergic Rhinitis
6. CB1400, Patented by Canopus BioPharma, Enters Phase II Clinical Trials for the Prevention of Mucositis in Patients With Cancer of the Head and Neck
7. Canopus BioPharma Strengthens its CB1400 Platform Technology for Mucositis and Oncology Treatments Through License Agreement With Wisconsin Alumni Research Foundation
8. Morria Biopharmaceuticals Plc Announces Regulatory Approval to Commence Phase II Clinical Study of MRX-4 in Allergic Rhinitis
9. Keryx Biopharmaceuticals, Inc. Announces Phase 2 Results on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Waldenstroms Macroglobulinemia at the 44th Annual Meeting of the American Society of Clinical Oncology
10. Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at the American Society of Clinical Oncology Meeting in Chicago, Illinois
11. Keryx Biopharmaceuticals Announces Termination of SUN-MACRO Phase 4 Trial
Post Your Comments:
(Date:6/26/2016)... , June 26, 2016 ... care operating models within the health care industry is ... financial efficiency , Deloitte offers a suite of ... business issues impacting efficient cost optimization: labor resource analysis, ... These services facilitate better outcomes and better economics ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... ... 24, 2016 , ... Dr. Amanda Cheng, an orthodontist ... has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be used ...
(Date:6/24/2016)... ... 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join ... wage raise to $12 an hour by 2020 and then adjusting it yearly to increase ... of the minimum wage, assure the wage floor does not erode again, and make future ...
Breaking Medicine News(10 mins):