Navigation Links
Mezzion Pharma Initiates Clinical Development Program To Evaluate Udenafil In Adolescents With Single Ventricle Heart Defects
Date:7/23/2014

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


'/>"/>
SOURCE Mezzion Pharma Co. Ltd.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Mezzion Pharma Announces Collaboration With New England Research Institutes To Evaluate Udenafil In Adolescents With Single Ventricle Heart Defects
2. Study Finds Utilizing Integrated Medical and Pharmacy Data Improves Ability to Forecast Use of High-cost Specialty Treatments
3. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
4. WuXi PharmaTech Files 2011 Annual Report on Form 20-F
5. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
6. Pharmaceutical Industry Service Company Awarded The UKs Most Prestigious Business Accolade in Recognition of Outstanding Achievement in International Trade
7. Academy of Managed Care Pharmacy (AMCP) Installs 2012-2013 Board of Directors
8. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
9. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
10. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
11. Thomson Reuters Launches New Mobile Oncology Decision Support Solution for R&D Pharmaceutical Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... -- HemaFlo Therapeutics, Inc. announced today that the United States Patent ... covering the use of NephroFlow to treat acute kidney injury ... said, "We are pleased to secure our rights to such ... PhD, HemaFlo,s founder, said, "We are pleased to secure our ... Dale Peterson , PhD, HemaFlo,s founder, said, "We are ...
(Date:2/8/2016)... , Feb. 8, 2016  Dynatronics Corporation ... of advanced-technology medical devices and rehabilitation equipment for ... congratulates the Denver Broncos, football team for winning ... Cullimore Jr. , Chairman and Chief Executive Officer.  ... and we look forward to enhancing their athletic ...
(Date:2/8/2016)... , Feb. 8, 2016  Sangamo BioSciences, ... therapeutic genome editing, announced that the U.S. Food ... Investigational New Drug (IND) application for SB-318, a ... therapy for Mucopolysaccharidosis Type I (MPS I). The ... Sangamo to initiate a Phase 1/2 clinical study ...
Breaking Medicine Technology:
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... Guruji Mahendra ... 9th, 10th and 11th, 2016 in honor of his birthday on February 10th. ... happiness. Mahendra Trivedi is known by over 250,000 people from over 40 different ...
(Date:2/7/2016)... ... February 07, 2016 , ... Women’s Excellence now ... the most minimally invasive approaches. , Women who have had multiple vaginal births ... factors include surgery to the pelvic floor, connective tissue disorders, and obesity. Women ...
(Date:2/7/2016)... ... February 07, 2016 , ... Dr. Todd Hobgood , ... medical and surgical expertise. Technically known as deoxycholic acid or previously as ATX-101, ... non-surgical alternative for reduction of fat below the chin (aka the “double chin”). ...
(Date:2/6/2016)... ... February 06, 2016 , ... With the FCPX ... warm color grades to their footage. A LUT is a Lookup Table that contains ... the corresponding color indicated by the table. By manipulating each pixel, LUT's can change ...
(Date:2/5/2016)... ... , ... Steven Tonkinson, 36, of Coconut Grove, Florida, ran the Miami Marathon ... 2003. This year, he ran all 26.2 miles with a green 25-pound ShelterBox strapped ... Heat. , This Sunday, while many are watching the Superbowl, Steven Tonkinson will strap ...
Breaking Medicine News(10 mins):