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

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, 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 patients and normal controls with macimorelin (AEZS-130) oral solution, compared to the currently used test with GHRH-Arginine intravenous administration.

Oral administration of macimorelin (AEZS-130) offers more convenience and simplicity over the current GHD tests used, requiring either intravenous or intramuscular administration. Additionally, macimorelin (AEZS-130) may demonstrate a more favorable safety profile than existing diagnostic tests, some of which may be inappropriate for certain patient populations e.g. diabetes mellitus or renal failure, and have demonstrated a variety of side effects which macimorelin (AEZS-130) has not thus far. These factors may be limiting the use of GHD testing and may enable macimorelin (AEZS-130) to become the diagnostic test of choice for GHD.

Juergen Engel, Ph.D., President and CEO of AEterna Zentaris stated, "We intend to file, as quickly as possible, the NDA for the use of macimorelin (AEZS-130) as a diagnostic test for GHD in adults, the timing of which will depend on the outcome of the Company's discussions with the FDA and the completion of the clinical program ultimately agreed upon. We believe an approval for this indication can be achieved in 2011."

Macimorelin (AEZS-130) has been granted Orphan Drug Designation for the diagnosis of growth hormone deficiency by the FDA, and AEterna Zentaris is now the sponsor of this orphan designation. Orphan Drug Designation confers a number of advantages to the further development of the drug, such as additional exclusivity for the molecule and the potential of waiving User fees at the time a NDA is filed.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are required by a governmental authority or applicable law.


Copyright©2009 PR Newswire.
All rights reserved

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:
(Date:11/30/2015)... and PETACH TIKVAH, Israel , Nov. 30, ... BCLI ), a leading developer of adult stem cell technologies ... Cell Therapeutics Ltd., has been awarded an additional grant of ... the Chief Scientist (OCS). This grant, the second this year, ... activities to approximately $1.8 million (approximately NIS7 million).  ...
(Date:11/27/2015)... PA (PRWEB) , ... November 27, 2015 , ... ... Technical Program that includes over 2,000 technical presentations offered in symposia, oral ... chemistry and applied spectroscopy, covers a wide range of applications such as, but ...
(Date:11/26/2015)... November 26, 2015 --> ... specializing in imaging technologies, announced today that it has received ... of the Horizon 2020 European Union Framework Programme for Research ... clinical trial in breast cancer. , --> ... --> --> The study aims ...
(Date:11/25/2015)... 2 nouvelles études permettent d , ... les souches bactériennes retrouvées dans la plaque dentaire ... . Ces recherches  ouvrent une nouvelle voie ... de l,un des problèmes de santé les plus ... --> 2 nouvelles études permettent d , ...
Breaking Biology Technology:
(Date:10/29/2015)... 29, 2015  The J. Craig Venter Institute (JCVI) ... Synthesis and Biosecurity: Lessons Learned and Options for the ... and Human Services guidance for synthetic biology providers has ... --> --> Synthetic biology ... potential to pose unique biosecurity threats. It now is ...
(Date:10/29/2015)... OXFORD, Connecticut , October 29, 2015 /PRNewswire/ ... "Company"), a biometric authentication company focused on the ... Wocket® smart wallet announces that StackCommerce, a leading ... will be featuring the Wocket® smart wallet on ... NXTD ) ("NXT-ID" or the "Company"), a ...
(Date:10/27/2015)... Oct. 27, 2015 Synaptics Inc. (NASDAQ: SYNA ... that Google has adopted the Synaptics ® ClearPad ... to power its newest flagship smartphones, the Nexus 5X ... --> --> Synaptics ... provide strategic collaboration in the joint development of next ...
Breaking Biology News(10 mins):