Aeterna Zentaris: Final Phase 3 Results for AEZS-130 in Adult Growth Hormone Deficiency Presented at ENDO Meeting

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[{"type":"text","content":"\n\n\n\n\n\nQUÉBEC CITY, June 26, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that final Phase 3\n results for its oral ghrelin agonist, AEZS-130, show that the drug is\n safe and effective in diagnosing adult growth hormone deficiency\n (AGHD). Jose M. Garcia, MD, PhD, of the Baylor College of Medicine and\n the Michael E. DeBakey VA Medical Center, disclosed these data during\n an oral presentation yesterday at the 94th ENDO Annual Meeting and Expo currently being held in Houston, Texas.\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 body mass index (BMI) and estrogen\n use. The objective of this clinical trial was to determine the efficacy\n and safety of 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-130 administration were 2.36ng/mL (range 0.03-33) and\n 17.71ng/mL (range 10.5-94), respectively. The receiver operating\n characteristic (ROC) plot analysis yielded an optimal GH cut-point of\n 2.7ng/mL, with 82% sensitivity, 92% specificity and a 13%\n misclassification rate. Obesity (BMI>30) was present in 58% of cases\n and controls, and peak GH levels were inversely associated with BMI in\n controls.\n\n\nAdverse events (AE) were seen in 37% of AGHD patients and in 21% of\n controls following AEZS-130. In contrast, 61% of AGHD subjects and 30%\n of controls experienced AEs with L-ARG+GHRH. The most common AEs after\n AEZS-130 were unpleasant taste (19.2%) and diarrhea (3.8%) for the AGHD\n patients and unpleasant taste (4.2%) and diarrhea (4.2%) for the\n matched controls. AEs were generally mild o...

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