Jun 21 2010
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.
Results
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.