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.
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.
About AEZS-130
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.
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.