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Aeterna Zentaris Announces First Patient Enrolled for Confirmatory Phase 3 Trial of Macrilen(TM) for the evaluation of AGHD
Aeterna Zentaris Announces First Patient Enrolled for Confirmatory Phase 3 Trial of Macril...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\nAeterna Zentaris Announces First Patient Enrolled for Confirmatory Phase 3 Trial of Macrilen™ for the evaluation of AGHD\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nAeterna Zentaris Announces First Patient Enrolled for Confirmatory Phase 3 Trial of Macrilen™ for the evaluation of AGHD\nCanada NewsWire\nQUEBEC CITY, Nov. 19, 2015\n\n\n\nQUEBEC CITY, Nov. 19, 2015 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZ) (the \"Company\") announced today that the first patient has been enrolled for the Company's confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (\"AGHD\").\n\nDavid A. Dodd, Chairman, President and Chief Executive Officer of the Company, remarked, \"We remain committed to the development of Macrilen™ because of our confidence in its efficacy and safety, as well as the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD.\"  \n\nAbout the Study\n\nThe confirmatory Phase 3 clinical study of Macrilen™, entitled Confirmatory validation of oral macimorelin as a growth hormone (GH) stimulation test (ST) for the diagnosis of adult growth hormone deficiency (AGHD) in comparison with the insulin tolerance test (ITT), is designed as a two-way crossover study with the insulin tolerance test as the benchmark comparator and will involve some 30 sites in the United States and Europe.  The study population will consist of approximately 110 subjects (at least 55 ITT-positive and 55 ITT-negative) with a medical history documenting risk factors for AGHD, and will include a spectrum of subjects from those with a low risk of having AGHD to those with a high risk of having the condition.  The primary endpoint is validation of a single oral dose of macimorelin for the diagnosis of AGHD, using the ITT as a comparator.  The coordinating investigator is Jose Manuel Garcia, MD, PhD, Associate Professor of Medicine-Endocrinolog...