SEOUL, South Korea, March 16, 2015 /PRNewswire/ -- Based on preliminary review of data generated via its multicenter, Phase I/II clinical study which evaluated the use of udenafil in adolescents with a single functional ventricle who had previously undergone Fontan surgical palliation, Mezzion Pharma today announced its commitment to proceed with definitive multinational phase III efficacy and safety trials under the Investigational New Drug Application (IND) previously filed with the US FDA.
The protocols for the Phase III trials are currently being finalized with the Pediatric Heart Network (PHN), which is funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
There are approximately 19,000 Fontan patients in the USA and Mezzion Pharma expects that the use of udenafil in such patients will be eligible for orphan-drug designation.
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
Director
Tel: +82 2 560 8008
Email: wgkim@mezzion.co.kr
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mezzion-pharma-commits-to-phase-3-clinical-trials-of-udenafil-in-adolescents-with-a-single-functional-ventricle-that-have-undergone-fontan-surgical-palliation-300050928.html
SOURCE Mezzion Pharma Co. Ltd.
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