Navigation Links
AEterna Zentaris to Complete Phase 3 Clinical Trial of Macimorelin (AEZS-130) as First Oral Diagnostic Test for Growth Hormone Deficiency
Date:10/19/2009

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

Page: 1 2 3

Related biology technology :

1. AEterna Zentaris completes management team with the appointment of Chief Medical Officer
2. AEterna Zentaris to Present at Upcoming UBS Global Life Sciences Conference in New York
3. AEterna Zentaris Announces Outcome of Managements Strategic Review
4. AEterna Zentaris to Further Develop Three Follow-up Multi-targeted Cytotoxic Candidates to AEZS-112 as Potential Novel Cancer Treatment
5. AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers
6. AEterna Zentaris to Present at the Upcoming Roth Capital Partners 20th Annual OC Growth Stock Conference in Dana Point, California
7. Aeterna Zentaris to Announce Fourth Quarter and Full-Year 2007 Financial and Operating Results on March 5, 2008
8. AEterna Zentaris Announces the Departure of SVP, Administrative and Legal Affairs
9. AEterna Zentaris and Paladin Labs Announce Sale and Purchase of Miltefosine Rights
10. Aeterna Zentaris Reports Fourth Quarter and Full-Year 2007 Financial and Operating Results
11. Aeterna Zentaris Begins Second Phase 3 Trial of Cetrorelix for Benign Prostatic Hyperplasia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... Neurotrope, Inc. (OTCQB: NTRP) today announced ... provide an update on Company activities. Access information:Date:Tuesday, ... 505-4369 (U.S. and Canada) or (719) 325-2315 Conference ... under "Investor Relations"The teleconference replay will be available ... 2014 at (888) 203-1112 (U.S. and ...
(Date:8/20/2014)... California (PRWEB) August 20, 2014 ... develop and apply the most complete climate and ... and demanding climate change issues. , Eight national ... forces with the National Center for Atmospheric Research, ... the new effort. Other participating national laboratories include ...
(Date:8/20/2014)...  Decision Resources Group finds that the vascular access device market ... India and China ... to the size of the United States ... much faster growth as a result of strong economic expansion, improving ... findings from Decision Resources Group,s coverage of the BRIC vascular access ...
(Date:8/20/2014)... 20, 2014  PAREXEL International Corporation (NASDAQ: ... at the Baird Healthcare Conference in New York.  ... Officer, will be making a presentation on PAREXEL and ... Sept. 3, 2014. A live webcast of ... of PAREXEL,s website at www.PAREXEL.com in the ...
Breaking Biology Technology:Neurotrope To Host Conference Call 2New Project Is the ACME of Addressing Climate Change 2New Project Is the ACME of Addressing Climate Change 3BRIC Vascular Access Device Market Valued at $1.6 Billion in 2013, Similar to the U.S. Market 2BRIC Vascular Access Device Market Valued at $1.6 Billion in 2013, Similar to the U.S. Market 3PAREXEL International To Present At Baird Healthcare Conference 2
... Institute of Standards and Technology (NIST) may have ... of computer memory now under development. The work, ... University (GMU), aims to optimize nanowire-based charge-trapping memory ... computers and cell phones that can operate for ...
... DIEGO, May 25, 2011 Anadys Pharmaceuticals, Inc. (Nasdaq: ... for the treatment of hepatitis C, announced today that it ... ANA773, the Company,s oral immuno-modulator that acts via the TLR-7 ... Annual Meeting in Chicago, IL.  The data from the completed ...
... 2011 WaferGen Biosystems, Inc. (OTCBB:WGBS), a leading ... it has entered into definitive agreements with three ... LLC, Deerfield Management and Merlin Nexus, and certain ... $30.4 million private placement financing of equity and ...
Cached Biology Technology:NIST 'nanowire' measurements could improve computer memory 2Anadys Highlights ANA773 Data to be Presented at ASCO 2Anadys Highlights ANA773 Data to be Presented at ASCO 3Anadys Highlights ANA773 Data to be Presented at ASCO 4WaferGen Announces $30 Million Financing 2WaferGen Announces $30 Million Financing 3WaferGen Announces $30 Million Financing 4
(Date:8/20/2014)... , Aug. 20, 2014 /CNW/ -  Issue ... warning and can quickly become life threatening for some children. ... many as 1.2 million Canadians have food allergies and this ... per cent of children are estimated to have food allergies.  ... from mild skin irritations and hives to breathing difficulties and ...
(Date:8/20/2014)... University, the Wellcome Trust Sanger Institute and the Swiss ... Mycobacterium pinnipedii from skeletons found in Peru which ... a relative of the TB bacterium that affects seals ... researchers assume that seals carried the pathogens from Africa ... was unexpected" comments Sebastien Gagneux, from the Swiss Tropical ...
(Date:8/20/2014)... are visible in in this image of the Para ... these were most likely intentionally set in order to ... forest or stand of trees where the land is ... include conversion of forestland to farms, ranches, or urban ... green of the Amazon Rainforest in the middle of ...
Breaking Biology News(10 mins):Information Update - Allergens and food safety at school - What's in your child's lunch? 2Information Update - Allergens and food safety at school - What's in your child's lunch? 3
... researchers are among a select group of scientists from ... National Cancer Institute (NCI) for their quest to answer ... Professor and Chair of Oncological Sciences and Ross Cagan, ... received the NCI,s new "Provocative Questions" grant, which was ...
... 2012 Novetta Solutions, LLC (Novetta), a portfolio ... acquisition of International Biometric Group, LLC (IBG). Novetta ... within the National Security community and other organizations ... established in March 2012 through the merger of ...
... can play a key role in feeding people and restoring their ... during their little-known involvement in the liberation of Bergen-Belsen at the ... a historical research paper published in the October issue of the ... been written about the role of the armed forces and medical ...
Cached Biology News:Mount Sinai researchers awarded 'Provocative Questions' grant from National Cancer Institute 2Mount Sinai researchers awarded 'Provocative Questions' grant from National Cancer Institute 3Novetta Solutions Acquires International Biometric Group, LLC 2Novetta Solutions Acquires International Biometric Group, LLC 3Bergen-Belsen lessons underline vital role that nurses can play in patient feeding 2Bergen-Belsen lessons underline vital role that nurses can play in patient feeding 3