Aeterna Zentaris: Phase 3 Results for AEZS-130 in AGHD Presented at GRS and IGF Society Congress

About this update from Cosciens Biopharma Inc.

[{"type":"text","content":"\n\n\n\n\n\nQUEBEC CITY, Oct. 18, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that Phase 3 results\n for its ghrelin agonist, AEZS-130, show that it has promise as a safe\n and simple oral diagnostic test for adult growth hormone deficiency\n (AGHD), with accuracy comparable to available testing procedures.\n Results were presented earlier today by George R. Merriam, MD, Director\n of the Clinical Study Unit at the VA Puget Sound Health Care System,\n and Professor of Medicine at the University of Washington, Seattle and\n Tacoma, WA, at the 6th International Congress of the Growth Hormone Research (GRS) and\n Insulin-like Growth Factor (IGF) Society, currently being held in\n Munich, Germany.\n\n\nJuergen Engel, PhD, President and CEO at Aeterna Zentaris, commented,\n \"The data presented earlier today by Dr. Merriam, extend those\n presented on this same study last June at ENDO by Dr. Jose M. Garcia,\n MD, PhD, of the Baylor College of Medicine and the Michael E. DeBakey\n VA Medical Center. Both confirm AEZS-130's potential as possibly the\n first approved oral diagnostic test for AGHD, with Dr. Merriam's data\n set showing the impact of Body Mass Index on cut-off values. We are\n currently focusing our efforts on submitting a New Drug Application for\n AEZS-130 in this indication during the first quarter of 2013.\"\n\n\nThe Study\n\n\nThis multicenter open-label study was originally designed as a\n cross-over trial of AEZS-130 vs growth hormone-releasing hormone\n (GHRH)+L-Arginine (ARG) in AGHD patients and in controls matched for\n Body Mass Index (BMI), estrogen status, gender and age. After 43 AGHD\n patients and 10 controls had been tested, GHRH became unavailable. The\n study was completed by testing 10 more AGHD patients and 38 controls\n with AEZS-130 alone.\n\n\nOf the 53 AGHD subjects enrolled, 52 received AEZS-130, and 50 who had\n confirmed AGHD prior to study entry were included in this analysis,\n along with 48 controls. Two AGHD subjects could not be matched due to\n the combination of young age, high BMI and estrogen use. The objective\n of this clinical trial was to determine the efficacy and safety of\n AEZS-130 in the diagnosis of AGHD.\n\n\nResults\n\n\nMean peak growth hormone (GH) levels in AGHD patients and controls\n following AEZS-...

More updates from Cosciens Biopharma Inc.