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Aeterna Zentaris Completes Phase 3 Study on AEZS-130 as First Oral Diagnostic Test for Adult Growth Hormone Deficiency
Jul. 26, 2011 (Canada NewsWire Group) -- Company expects to file New Drug Application Q...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n Jul. 26, 2011 (Canada NewsWire Group) -- \n\n#ReleaseContent TABLE\n{\n BORDER-COLLAPSE: collapse\n}\nTR.cnwUnderlinedCell TD\n{\n BORDER-BOTTOM: #000000 1px solid\n}\nTR.cnwDoubleUnderlinedCell TD\n{\n BORDER-BOTTOM: #000000 3px double\n}\nTR.cnwBoldUnderlinedCell TD\n{\n BORDER-BOTTOM: #000000 3px solid\n}\nTD.cnwUnderlinedCell\n{\n BORDER-BOTTOM: #000000 1px solid\n}\nTD.cnwDoubleUnderlinedCell\n{\n BORDER-BOTTOM: #000000 3px double\n}\nTD.cnwBoldUnderlinedCell\n{\n BORDER-BOTTOM: #000000 3px solid\n}\n#ReleaseContent TABLE.cnwBorderedTable TD\n{\n BORDER-RIGHT: black 1px solid;\n PADDING-RIGHT: 2px;\n BORDER-TOP: black 1px solid;\n PADDING-LEFT: 2px;\n PADDING-BOTTOM: 2px;\n BORDER-LEFT: black 1px solid;\n PADDING-TOP: 2px;\n BORDER-BOTTOM: black 1px solid;\n BORDER-COLLAPSE: collapse\n}\n#ReleaseContent TABLE TD\n{\n PADDING-RIGHT: 2px;\n PADDING-LEFT: 2px;\n PADDING-BOTTOM: 2px;\n PADDING-TOP: 2px\n}\n\n\nCompany expects to file New Drug Application\n\n\nQUÉBEC CITY, July 26, 2011 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the "Company") today announced completion of its\n Phase 3 study with AEZS-130 as the first oral diagnostic test for Adult\n Growth Hormone Deficiency (AGHD). The Company is currently proceeding\n with detailed analyses of the data and preparing for a pre-New Drug\n Application (NDA) meeting with the U.S. Food and Drug Administration\n (FDA) in the upcoming months, which would be followed by the filing of\n a NDA for the registration of AEZS-130 in the United States.\n\n\n"We wish to thank all those involved in this project for their utmost\n dedication. Preliminary results are encouraging and we therefore expect\n to submit a NDA to the FDA. We believe that AEZS-130 could become the\n first approved oral test for the diagnosis of AGHD, providing patients\n with a potentially safer, accurate and more convenient alternative to\n the current injectable tests", stated Juergen Engel, Ph.D., President\n and CEO at Aeterna Zentaris.\n\n\nStudy History\n\n\nThe study titled, "A Multi-Center Study Investigating a New, Oral Growth Hormone\n Secretagogue (AEZS-130, formerly ARD-07) as a Growth Hormone (GH)\n Stimulation Test in Terms of Safety and Efficacy", was originally initiated to compare the performance of AEZS-130 against\n the then-avail...