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:12/2/2016)... 2016  Maxor National Pharmacy Services, LLC ("Maxor"), today announced ... ("PSI").  The combination of Texas -based Maxor ... PSI bring together both company,s clinical expertise and high-touch patient ... industry-leading specialty pharmacy. About Maxor ... , , ...
(Date:12/2/2016)... 2016 Lianluo Smart Limited (Nasdaq: ... which develops, markets and sells medical devices and ... and international markets, recently attended the ... New Progress Forum, co-hosted by the Institute of ... , Guangdong Provincial People,s Hospital and Cardiology Department ...
(Date:12/2/2016)... The concept of rare diseases and the idea that a ... been taking shape in Europe since ... related to orphan medicinal products have been emerging at both ... individually. Many member states in the EU have led the ... products, the result of which took the shape of the ...
Breaking Medicine Technology:
(Date:12/2/2016)... Hawaii (PRWEB) , ... December 02, 2016 , ... ... 2016 at the Hyatt Regency Waikiki Beach Resort and Spa in Honolulu, offering ... in the field of pain management. , The demand for supplemental training ...
(Date:12/2/2016)... ... 02, 2016 , ... Sourced from the Isbre Springs beneath the 5,000 year ... natural purity of just 6 ppm TDS (Total Dissolved Solids) in addition to its ... available in several ShopRite and FoodTown stores in NJ and received rave comments from ...
(Date:12/2/2016)... ... December 02, 2016 , ... Yisrayl Hawkins, at The House ... this current generation fits into Bible Prophecy. Yisrayl says this generation, known as the ... this conclusion, showing how the details line up exactly with Bible Prophecy – a ...
(Date:12/2/2016)... ... 02, 2016 , ... Clarify Health Solutions, Inc., the leading ... in an initial round of funding. The round was led by experienced investors ... receive far better care through the application of the best technologies from other ...
(Date:12/2/2016)... Philadelphia, PA (PRWEB) , ... December 02, 2016 ... ... healthcare and pharmaceutical organizations to build intelligent, connected applications, was named the best ... , The winner announcement was made today by the Software & ...
Breaking Medicine News(10 mins):