Mezzion Pharma Initiates Clinical Development Program To Evaluate Udenafil In Adolescents With Single Ventricle Heart Defects - WCIV-TV | ABC News 4 - Charleston News, Sports, Weather

Mezzion Pharma Initiates Clinical Development Program To Evaluate Udenafil In Adolescents With Single Ventricle Heart Defects

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

SOURCE Mezzion Pharma Co. Ltd.

SEOUL, South Korea, July 23, 2014 /PRNewswire/ -- Mezzion Pharma Co. Ltd., announced that it has initiated a clinical program to evaluate the use of udenafil to treat adolescents who have undergone the Fontan surgical palliation for single ventricle heart defects. The clinical program will follow protocols developed by a subcommittee made up of representatives of the Pediatric Heart Network (PHN), a multi-center clinical research network funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

The studies, which will be led by PHN researchers, will assess the improvement in certain acute and chronic symptoms in adolescents who had the Fontan procedure earlier in life.

The Fontan operation is the final surgery in the strategy of staged palliation for children born with congenital heart defects resulting in functional single-ventricle physiology. Fontan patients have a significantly shortened life span, often not surviving past the third or fourth decade of life, mainly due to deteriorating ventricular performance and increasing pulmonary vascular resistance.   

PDE5 inhibitors have demonstrated utility in reducing pulmonary vascular resistance and improving ventricular performance in other types of patients. Those characteristics make PDE5 inhibitors, especially a long acting compound such as udenafil, an attractive potential therapy for the Fontan population in which cardiac output is limited by the absence of a sub-pulmonary ventricle. A medication capable of allowing for more efficient transit of blood through the pulmonary vascular bed could allow for improvement in cardiac preload, and therefore improved cardiac output for any given level of systemic venous pressure.

Mezzion Pharma has filed an Investigational New Drug Application (IND) with the FDA and has initiated the first trials in adolescents. There are approximately 19,000 Fontan patients in the US and the company expects that the use of udenafil in such patients for the purpose outlined above will be eligible for orphan-drug designation.

Mr. Dean Park, Chairman, Mezzion Pharma, commented that "We are extremely pleased to collaborate with the PHN in a combined effort to improve the quality of life and lifespan of these adolescents."

Mezzion Pharma Co. Ltd.

Mezzion Pharma is a publicly-listed biotech company in Korea focusing on the development of new drugs.

Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.

Contact:
Mr. Won Geun KIM
General Manager
Tel: +82 2 560 8008
Fax: + 82 2 563 6517
Email: wgkim@mezzion.co.kr

©2012 PR Newswire. All Rights Reserved.

Powered by WorldNow

ABCNews4 WCIV-TV

888 Allbritton Dr.
Mt. Pleasant, SC 29464
843-881-4444 | Advertising Information

Public Information File

For assistance with accessing WCIV-TV's public information file, click here.

Advertising

Advertising Credit Application and Terms and Conditions PDF.

Powered by WorldNow
All content Copyright © 2014 WCIV and Worldnow. All Rights Reserved.
For more information on this site, please read our Privacy Policy and Terms of Service.