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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.
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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 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 www.aezsinc.com.
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.
SOURCE AETERNA ZENTARIS INC.
