QUEBEC CITY, Oct. 19 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has initiated activities intended to complete the clinical development of the growth hormone secretagogue (GHS) / ghrelin agonist compound macimorelin (AEZS-130) which could be the first oral diagnostic test approved for growth hormone deficiency (GHD). Macimorelin is the International Non-proprietary Name (INN) designated for the compound by the World Health Organization (WHO).
AEterna Zentaris has already assumed the sponsorship of the Investigational New Drug application (IND) and is discussing with the FDA the best way to complete the ongoing Phase 3 clinical trial, and subsequently file a New Drug Application (NDA) for approval of macimorelin (AEZS-130) as a diagnostic test for GHD in adults.
The Phase 3 clinical trial of macimorelin (AEZS-130), to establish it as a diagnostic test for GHD in adults, was initiated in the USA by AEterna Zentaris' former licensee, Ardana Biosciences Ltd. (Ardana); however, the trial was suspended before completion because of Ardana's insolvency. Additionally, AEterna Zentaris regained all rights and acquired all assets related to macimorelin (AEZS-130) as a result of the insolvency process.
The pivotal Phase 3 trial (listed in clinicaltrials.gov, study #NCT00448747) is designed to investigate the safety and efficacy of the oral administration of macimorelin (AEZS-130) as a growth hormone stimulation diagnostic test compared to GHRH + L-arginine, administered intravenously. Currently available results from this study, previously reported by G. Merriam et al. (Poster P2-749, ENDO '09, June 2009), demonstrated no safety issues and better discrimination between adult GHD patie
|SOURCE AETERNA ZENTARIS INC.|
Copyright©2009 PR Newswire.
All rights reserved