Business
Aeterna Zentaris Announces Favorable Top-Line Results of Completed Phase 3 Study on AEZS-130 as First Oral Diagnostic Test for Adult Growth Hormone Deficiency
Company will file New Drug Application QUÉBEC CITY, Aug. 30, 2011 /CNW Telbec/ - ...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nCompany will file New Drug Application\n\n\nQUÉBEC CITY, Aug. 30, 2011 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the \"Company\") today\n announced favorable top-line results of its completed Phase 3 study\n with AEZS-130 as the first oral diagnostic test for Adult Growth\n Hormone Deficiency (AGHD). The results show that AEZS-130 reached its\n primary endpoint demonstrating 90% area-under-the-curve (AUC) of the\n Receiver Operating Characteristic (ROC) curve, which determines the\n level of specificity and sensitivity of the product. The Company is\n currently proceeding with further detailed analyses of the data and\n preparing for a pre-New Drug Application (NDA) meeting with the U.S.\n Food and Drug Administration (FDA) in the upcoming months, which would\n be followed by the filing of a NDA for the registration of AEZS-130 in\n the United States.\n\n\nThe parameters of the study, as defined below under Study Design, were\n achieved as agreed to with FDA under our Special Protocol Assessment\n (SPA). Importantly, the primary efficacy parameters show that the study\n achieved both specificity and sensitivity at a level of 90% or\n greater.  In addition, 8 of the 10 newly enrolled AGHD patients were\n correctly classified by a pre-specified peak GH threshold level. The\n use of AEZS-130 was shown to be safe and well tolerated overall\n throughout the completion of this trial.\n\n\n\"We are pleased with the results obtained and we therefore expect to\n meet with the FDA and work out the content of a submission for an NDA.\n We believe that AEZS-130 could become the first approved oral test for\n the diagnosis of AGHD, providing patients with a potentially safer,\n accurate and more convenient alternative to the current injectable\n tests\", stated Juergen Engel, Ph.D., President and CEO at Aeterna\n 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\n against the then-available diagnostic growth hormone-releasing hormone\n (GHRH) Geref Diagnostic® + Arginine (ARG) standard test. Geref Diagnostic® was subsequently withdrawn from...