Navigation Links
CeNeRx BioPharma Announces Positive Phase I Results in First Human,Trial of Third Generation RIMA Antidepressant

- Tyrima Demonstrates Good Safety Profile and Excellent Pharmacokinetic Properties -

RESEARCH TRIANGLE PARK, N.C., March 13, 2007 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced top-line results from a Phase I clinical trial of Tyrima(TM), its lead candidate for the treatment of depression and anxiety. In this study, Tyrima was safe and well tolerated. Tyrima is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMAs.

The single-dose, placebo-controlled trial evaluated Tyrima in 41 subjects with doses escalating from 5 mg to 120 mg over the course of the study. Tyrima was well tolerated with no clinically significant adverse events even at the highest dose of 120 mg. Tyrima achieved high plasma concentrations that increased linearly with dose, and the favorable pharmacokinetic half-life should permit once or twice daily dosing. None of the safety and tolerability issues commonly associated with conventional monoamine oxidase A inhibitors (MAOIs) were seen in this study.

"The triple mechanism of MAOI antidepressants has the potential to provide enhanced efficacy to the 30% of patients who do not respond to current therapies, but use of these drugs has been limited by their propensity to cause serious side effects," said Dr. Atul Pande, chief medical officer of CeNeRx. "It is therefore encouraging that Tyrima, a selective and reversible MAO inhibitor specifically designed to avoid these side effects, demonstrated a promising safety profile in its first clinical trial, even at the highest dose. These results provide a strong foundation for proceeding to multiple dose safety studies."

Tyrima's unique mechanism elevates the levels of three key neurotransmitters (serotonin, norepinephrine and dopamine) that affect mood and anx iety, in contrast to the leading antidepressants available today that affect only the single neurotransmitter serotonin. This triple action mechanism has the potential for enhanced efficacy while the selective and reversible nature of RIMAs is intended to avoid toxic side effects.

"The excellent safety profile demonstrated in this study is the first confirmation in humans that Tyrima has the potential to deliver on the promise of the RIMA approach, and these positive results represent an important milestone for our company," said Barry Brand, chief executive officer of CeNeRx. "In contrast to other MAO inhibitors, our third generation RIMA series is designed to bind selectively and reversibly, with the goal of significantly reducing the cardiovascular risks and other side effects typically associated with the MAOI class. These safety results, along with the high plasma levels and favorable pharmacokinetics demonstrated in the study, support advancing Tyrima into a multiple dose safety study in late spring."

Tyrima could be the first RIMA antidepressant available in the U.S. market, and it has patent protection through 2026. CeNeRx has worldwide rights to develop and commercialize Tyrima.

The Tyrima Phase l safety trials began in January following a successful review of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration.

About CeNeRx BioPharma

CeNeRx (SEN-er-ex) is a privately held clinical stage company developing and commercializing innovative and improved treatments for diseases of the central nervous system. The company focuses on identifying and developing promising therapeutics to treat diseases related to neurotransmitters, including anxiety, bipolar disorder, dementia, depression, epilepsy, neuropathic pain, schizophrenia, and Parkinson's and Alzheimer's diseases. CeNeRx's most advanced compounds, reversible inhibitors of monoamine oxidase, or RIMAs, are in Phase I and late pre-clinical d evelopment for the treatment of major depressive disorder. More information about CeNeRx BioPharma can be found at


    GendeLLindheim BioCom Partners

    Barbara Lindheim

    212 918 4650

CONTACT: Barbara Lindheim of GendeLLindheim BioCom Partners,+1-212-918-4650, for CeNeRx BioPharma, Inc.

Web site:

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
2. Array BioPharma to Present at the C.E Unterbeg, Towbin Emerging Growth Conference
3. DOR BioPharma Announces Issuance of European Patent for Its Oral Multivalent Botulinum Toxin Vaccine BT-VACC
4. DOR BioPharma Announces Publication Describing Results of Its Multivalent Botulinum Toxin Vaccine BT-VACC
5. Array BioPharma Reports New Clinical Data on Its Anti-Inflammatory Drugs
6. PDL BioPharma Announces Long-Term Nuvion Data Presented at 2007 Digestive Disease Week
7. AVI BioPharma Reports Positive Pre-Clinical Influenza Data
8. Helix BioPharma Corp. Announces Positive Phase II Clinical Results with its Topical Interferon Alpha-2b
9. Integrated BioPharmas Proprietary Vaccine Technology Achieves Strong Positive Results
10. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
11. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
Post Your Comments:
(Date:12/1/2015)... Pa. , Dec. 1, 2015  Today, ... announced the launch of CareFront, a first-of-its-kind population ... patients diagnosed with cancer. Designed to be built ... diagnosed cancer patients with resources for their care ... The program also offers tools to help patients ...
(Date:12/1/2015)... , Dec. 1, 2015   Craneware, ... value cycle solutions, today announced the company will ... Pharmacy ChargeLink ® solution at the ... Midyear Clinical Meeting . The new features are ... process of monitoring and managing enterprise-wide pharmacy charges ...
(Date:12/1/2015)... 1, 2015  Booth #3506 – Claymount is featuring its ... meeting of the Radiological Society of North America ... year. Based in the Netherlands , Claymount ... Systems (NYSE: VAR ) and is one of the ... solid state automatic exposure control systems for controlling dose during ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... ... is the first health care provider in the region to offer the vBloc® Therapy ... vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients over ... to 45 kg, or a BMI of at least 35 to 39.9 kg with a ...
(Date:12/1/2015)... ... December 01, 2015 , ... Dr. Paul Vitenas, one of the ... been named by MedEsthetics magazine as the Best Single Physician Practice in the nation. ... many elite aesthetic physicians honored by the industry publication. , Dr. Vitenas said ...
(Date:12/1/2015)... Delaware (PRWEB) , ... December 01, 2015 , ... ... winner at the 7th Annual 2015 Golden Bridge Business Awards under the New ... is a zero capex web based sample management software that helps ...
(Date:12/1/2015)... ... 2015 , ... For many X-rays taken at hospitals, doctors’ ... by the radiologist. The marking utensils are so small, however, they are difficult ... way to alleviate this problem. , He developed the patent-pending MARK N SHOW ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... it has been awarded a fixed price per sprint agile development contract to ... at $34 million over five years, provides software engineering, infrastructure, as well as ...
Breaking Medicine News(10 mins):