, Jan. 10, 2014
/PRNewswire/ -- Mezzion Pharma Co. Ltd., announced that it has signed an agreement with New England Research Institutes, Inc., who are authorized by the National Heart, Lung, and Blood Institute-supported Pediatric Heart Network
(PHN) to manage and conduct clinical trials on its behalf. The clinical studies to be conducted under this agreement were developed by a subcommittee made up of representatives of the PHN. The studies will be funded by a grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.
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 will file an Investigational New Drug Application (IND) with the FDA early in 2014 with clinical studies beginning soon after. 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 be entering into this agreement with NERI and to collaborate with the PHN and the NHLBI 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.
Mr. Won Geun KIM
Tel: +82 2 560 8008
Fax: + 82 2 563 6517
James L.Yeager, RPh, PhD
Executive Vice President & Board member
Tel: +1 847-2839176
SOURCE Mezzion Pharma Co. Ltd.