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:11/26/2015)... , November 26, 2015 ... addition of the "2016 Future Horizons ... of Abuse Testing Market: Supplier Shares, Country ... report to their offering. --> ... the "2016 Future Horizons and Growth ...
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ( ... "Advanced Wound Care Market by Type (Dressings, Therapy Devices, ... (In-Patient Facility, Out-Patient Facility), and Geography - Global Forecast ... --> --> The purpose ... and forecast of the global advanced wound care market. ...
(Date:11/26/2015)... , November 26, 2015 ... --> adds "Global Repaglinide ... "Investigation Report on China Repaglinide Market, ... forecasts data and information to its ... . --> ...
Breaking Medicine Technology:
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... According ... at the recent 2015 American Dental Association meeting in Washington D.C. revolved around the ... protect a patient’s overall health. The talk stressed the link between periodontal disease (more ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... in America. As people age, more care is needed, especially with Alzheimer’s, dementia ... medical professionals are being overworked. The forgotten part of this equation: 80 percent ...
(Date:11/27/2015)... ... November 27, 2015 , ... "When I was traveling, I ... Hillside, N.J. "Many people catch diseases simply from sitting on such dirty toilet ... protected from germs." , He developed the patent-pending QUDRATECS to eliminate the need ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ProSidebar: Fashion ... Final Cut Pro X. With ProSidebar: Fasion, video editors can easily add an ... as a minimalist title opener. Utilize presets featuring self-animating drop zones, lines, bars, ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for end ... Microsoft Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ membership ...
Breaking Medicine News(10 mins):