QUÉBEC CITY, June 21 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), (the "Company") a late-stage drug development company specialized in oncology and endocrine therapy, today announced that a poster on its oral synthetic growth hormone secretagogue/ghrelin receptor agonist, AEZS-130, was presented yesterday at the 92nd Annual Endocrine Society (ENDO) Meeting and Expo, which is held through June 22, 2010 at the San Diego Convention Center in San Diego, California. The preclinical data showed that AEZS-130 is a potent and safe oral synthetic Growth Hormone (GH) releasing compound with potential utility as a diagnostic test for growth hormone deficiencies, as well as a therapeutic for a range of diseases including treatment of cancer induced cachexia. AEZS-130 is currently in a Phase 3 trial as a diagnostic test for GH deficiency in adults.
The poster #851112 entitled, "Pharmacological and Toxicological Evaluation of AEZS-130/Ghrelin Receptor Agonist, a Novel, Oral Synthetic Growth Hormone Secretagogue for the Diagnosis of Growth Hormone Deficiency", Babette Aicher, Peter Schmidt, Elena Bresciani, Vittorio Locatelli, Daniel Perrissoud, Michael Teifel, further confirms the high affinity binding of AEZS-130 to GHS-R1A and demonstrates its functional ghrelin agonistic activity in various cell-based assay systems covering ghrelin receptors of different species. It also shows that a single oral treatment of fed rats with 24 mg/kg of AEZS-130 is capable of inducing significant growth hormone release in a time dependent manner, which is paralleled by AEZS-130 plasma levels.
The ability of AEZS-130 to increase growth hormone levels after repeated oral treatment of five days was demonstrated in beagle dogs, showing a 4-10 fold increase in the area under the curve of growth hormone levels. The fact that the growth hormone secretagogue effect was maintained after repeated dosing paves the way for the future therapeutic use of this compound. Safety of AEZS-130 was shown in various early safety and toxicity assays in vitro, as well as in preclinical safety and toxicity studies in rats and dogs.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "We are very pleased with these preclinical data which confirm AEZS-130's safety as well as its potential, both as a diagnostic test and a therapeutic agent for growth hormone deficiencies. We now look forward to successfully completing our current Phase 3 registration trial with this compound as a diagnostic test for growth hormone deficiency in adults, and the possible subsequent NDA filing in the U.S. for this indication."
A copy of the abstract is currently available on the ENDO website at www.endo-society.org.
AEZS-130 is a novel, oral growth hormone secretagogue (GHS) which exerts its effect by binding to the growth hormone secretagogue receptor GHS-R1A, which is the receptor for the physiological peptide ligand ghrelin. This mechanism of action was determined previously by binding studies assessing the affinity for the GHS-R1A by using membrane preparations from human pituitary gland, as well as transiently expressing LLC-PK1 cells (Ref. 1). AEZS-130 is currently in a Phase 3 trial as a diagnostic test for GH deficiency in adults.
Reference: 1. Guerlavais et al.(2003). New active series of growth hormone secretagogues. J. Med. Chem. 46, 1191-1203.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.
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.
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