Navigation Links
CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima(TM)

- Tyrima Exhibits Excellent Safety Profile and Favorable Pharmacokinetics

in Phase I Studies -

RESEARCH TRIANGLE PARK, N.C., Jan. 16 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced the successful completion of the Phase l clinical program for Tyrima(TM), its lead candidate for the treatment of depression and anxiety. Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A. The Phase l program included acute dose, repeat dose and fed-fasted studies. The results of all studies were favorable, showing that Tyrima was safe and well tolerated and exhibited good pharmacokinetic properties.

"Tyrima has the potential to be the first triple-action antidepressant capable of treating a broad patient population, and we are very pleased with the safety and tolerability observed in the Phase l clinical program," said Dr. Daniel Burch, R&D head and chief medical officer of CeNeRx. "Monoamine oxidase A inhibitors (MAOI) have demonstrated efficacy advantages over conventional antidepressants, but their use has been limited by their potential for serious adverse food effects. In these Phase l studies, Tyrima demonstrated good safety and excellent drug-like properties, with a positive pharmacokinetic profile at all doses tested and minimal signs of fed-fasted effects. We look forward to initiating the Phase ll program in the second quarter of 2008."

Like conventional MAOI agents, the triple-action mechanism of Tyrima elevates the levels of three key neurotransmitters (serotonin, norepinephrine and dopamine) that positively affect mood and anxiety. In contrast, most of the current leading antidepressant drugs affect only the single neurotransmitter serotonin. However, unlike older MAOIs, the unique selectivity and reversibility of CeNeRx's Tyrima should enable patients to benefit from the efficacy advantages of the class while avoiding the food- associated cardiovascular side effects of older MAOIs. The potential for these adverse effects has greatly restricted the use of conventional MAOI agents.

The Phase l program evaluated a range of Tyrima doses in 65 subjects. The repeat dose study results confirmed the positive findings of the acute dose trial that were reported previously. Tyrima was well tolerated, with no clinically significant adverse events reported at any dose. It achieved high plasma concentrations and exhibited a favorable pharmacokinetic half-life consistent with once- or twice-daily dosing.

"Successful completion of the Phase l program is a major milestone for our third-generation RIMA agents, whose triple-action mechanism has the potential to provide greater antidepressant efficacy to the many patients who do not obtain adequate relief from currently available therapies," said Barry Brand, chief executive officer of CeNeRx. "Tyrima offers a mechanism of action that is well-precedented and it has novel safety advantages. We look forward to rapidly advancing the Phase ll program."

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 (SEN-er-ex) 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 completed Phase I 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 preclinical pipeline of selective cannabinoid compounds for the treatment of pain, glaucoma and obesity. 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. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
2. XTL Biopharmaceuticals Presents Data Regarding its Hepatitis C Virus Small Molecule Program at Hep Dart 2007 - an International Scientific Conference on Viral Hepatitis
3. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
4. Immunosyn Announces Biozyme Labs Receipt of MHRA Manufacturing License Approval in Europe for the Biopharmaceutical SF-1019
5. Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
6. Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
7. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
8. Morria Biopharmaceuticals Plc Initiates Phase I Clinical Study of MRX-4 in Allergic Rhinitis
9. Keryx Biopharmaceuticals to Present at William Blair & Company Small-Cap Growth Stock Conference
10. Nabi Biopharmaceuticals Announces Continued Positive NicVAX Phase 2b Data at Nine Months
11. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
Post Your Comments:
(Date:11/30/2015)... , Nov. 30, 2015  Hanger, Inc. (NYSE: ... restatement of the terms of its previously announced consent ... to its $200,000,000 aggregate principal amount 7⅛% Senior Notes ... (i) the consent fees payable pursuant to the Consent ... Notes and (iii) the expiration date of the Consent ...
(Date:11/30/2015)...  Precision Image Analysis Inc. (PIA), a leading ... a dramatic expansion of its capabilities as a ... ISO-9001:2008 certification for its Quality Management System, PIA ... and procedures. This expansion enables PIA to support ... Lab services include design and optimization of protocols, ...
(Date:11/30/2015)... and REHOVOT, Israel , Nov. 30, ... company focused on acquiring and developing innovative therapies for ... appointment of Keith A. Katkin as chairman ... J. Flesher , chief executive officer for OticPharma, Ltd.  ... organizations.  As chairman, he will be able to share ...
Breaking Medicine Technology:
(Date:11/30/2015)... , ... November 30, 2015 , ... ... (ASI) as their exclusive channel partner for the Nutraceutical Specialties products into oral ... the US, effective immediately. , “We are pleased to announce our expanded ...
(Date:11/30/2015)... ... 2015 , ... Medicalis, a leading developer of enterprise-scale Imaging ... (RSNA) annual meeting, being held November 29 – December 3, 2015, that its ... company has completed installations for Integrated Delivery Network (IDN) customers such as WellSpan, ...
(Date:11/30/2015)... ... November 30, 2015 , ... Holcomb – Kreithen Plastic ... surgery practices in Florida, is proud to announce that Dr. Joshua Kreithen, one ... Ethicon Inc., a Johnson & Johnson Company. , Ethicon is a global medical ...
(Date:11/30/2015)... ... November 30, 2015 , ... Insightra Medical, Inc. and ... Mesh technology for soft tissue repair in the US via Insightra’s national direct ... surgical mesh intended to support and reinforce soft tissue for 6-9 months before ...
(Date:11/30/2015)... ... ... TransPack Volume 6 features 30 customizable transitions created exclusively for use within ... with blur & drop shadow options. Utilize the controls in the inspector window ... the next with TransPack's easily customizable styles. , TransPack Volume 6 features ...
Breaking Medicine News(10 mins):