Aeterna Zentaris: Phase 3 Results For AEZS-130 In AGHD Presented At GRS And IGF Society Congress
QUEBEC CITY, Oct. 18, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that Phase 3 results for its ghrelin agonist, AEZS-130, show that it has promise as a safe and simple oral diagnostic test for adult growth hormone deficiency (AGHD), with accuracy comparable to available testing procedures. Results were presented earlier today by George R. Merriam, MD, Director of the Clinical Study Unit at the VA Puget Sound Health Care System, and Professor of Medicine at the University of Washington, Seattle and Tacoma, WA, at the 6 th International Congress of the Growth Hormone Research (GRS) and Insulin-like Growth Factor (IGF) Society, currently being held in Munich, Germany.
Juergen Engel, PhD, President and CEO at Aeterna Zentaris, commented, "The data presented earlier today by Dr. Merriam, extend those presented on this same study last June at ENDO by Dr. Jose M. Garcia, MD, PhD, of the Baylor College of Medicine and the Michael E. DeBakey VA Medical Center. Both confirm AEZS-130's potential as possibly the first approved oral diagnostic test for AGHD, with Dr. Merriam's data set showing the impact of Body Mass Index on cut-off values. We are currently focusing our efforts on submitting a New Drug Application for AEZS-130 in this indication during the first quarter of 2013."
This multicenter open-label study was originally designed as a cross-over trial of AEZS-130 vs growth hormone-releasing hormone (GHRH)+L-Arginine (ARG) in AGHD patients and in controls matched for Body Mass Index (BMI), estrogen status, gender and age. After 43 AGHD patients and 10 controls had been tested, GHRH became unavailable. The study was completed by testing 10 more AGHD patients and 38 controls with AEZS-130 alone.
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