AEterna Zentaris Announces Phase I Positive Results for its Oral Growth Hormone Secretagogue Compound EP-1572
April 19 2005 - 8:32AM
PR Newswire (US)
AEterna Zentaris Announces Phase I Positive Results for its Oral
Growth Hormone Secretagogue Compound EP-1572 Potential applications
for growth disorders in children and cachexia (muscle wasting)
associated with chronic disease QUEBEC CITY, April 19
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) today announced positive results in a Phase I study of its
oral Growth Hormone Secretagogue (GHS), EP-1572. Conducted by
Ardana plc (LSE:ARA), AEterna Zentaris' development and marketing
partner for EP- 1572, the study provides clear evidence that this
compound is able to induce a significant rise in growth hormone
levels. Potential applications include treatment for growth
retardation in children and cachexia associated with chronic
disease such as AIDS and cancer. EP-1572, the only
orally-administered specific GHS in development, presents a major
competitive advantage in terms of ease and convenience of delivery
over current treatments which are only available through
injections. The open, randomised, placebo-controlled
dose-escalation Phase I study involved a total of 36 healthy male
volunteers, divided into three groups of 12 volunteers. Nine
subjects in each group received a single oral dose of EP-1572 -
0.005 mg/kg in the first group, 0.05 mg/kg in the second group and
0.5 mg/kg in the third group - with the other three subjects in
each group receiving a placebo. All subjects had been initially
checked for their ability to release growth hormone by the
intravenous administration of another hormone, growth hormone
releasing hormone (GHRH). The data demonstrated that between 1-2
hours after drug administration there was a statistically
significant increase in the levels of growth hormone in the blood
without any effect on other hormones with the mean GH value being
79.12 ng/ml at the highest dose of EP-1572 (p=0.009), compared to
52.62 ng/ml with GHRH and 3.58 ng/ml for placebo. In all cases,
EP-1572 was well tolerated and no adverse events were reported.
Additional studies are ongoing to accelerate development of EP-1572
for growth hormone disease and the more significant marketing
opportunity of cachexia associated with chronic disease. In 2004
the global growth hormone market was estimated to be worth US$2.3
billion. (Source: Wood Mackenzie's Product View December 2004).
About Growth Hormone Secretagogues (GHS) and EP-1572 Growth Hormone
Secretagogues (GHS) represent a new class of pharmacological agents
which directly stimulate growth hormone (GH) secretion from the
pituitary gland. EP-1572 is the only peptidomimetic GHS compound in
its class to be orally administered; other treatments are available
through daily injections. EP-1572 has potential applications for
the treatment of growth hormone disorders (GHD) such as growth
retardation in children and cachexia in AIDS patients. There are
currently no GHS's on the market. About EP-1572 strategic alliance
with Ardana plc In 2002, AEterna Zentaris granted Ardana an
exclusive worldwide license to develop and market the growth
hormone secretagogue EP-1572. Ardana is funding the activities
necessary to obtain regulatory and marketing approvals.
Furthermore, the agreement provides milestone payments, as well as
royalties on future worldwide net sales of EP-1572 among other
elements to AEterna Zentaris. About Ardana Ardana plc (LSE:ARA) is
an emerging pharmaceutical company focused on the discovery,
development and marketing of innovative products to improve human
reproductive health, a US$23.8 billion market. Since its
foundation, Ardana has maintained a broad and balanced portfolio to
manage risk and actively pursues product and technology
in-licensing and out-licensing to maintain a robust pipeline. About
AEterna Zentaris Inc. AEterna Zentaris Inc. is an oncology and
endocrine therapy focused biopharmaceutical company with proven
expertise in drug discovery, development and commercialization. The
Company's broad 20 product pipeline leverages five different
therapeutic approaches, including LHRH antagonists and signal
transduction inhibitors. The lead LHRH antagonist compound,
cetrorelix, is currently marketed for in vitro fertilization under
the brand name Cetrotide(R). Cetrorelix is also in late-stage
clinical development for endometriosis and benign prostate
hyperplasia (BPH). The lead signal transduction inhibitor compound,
perifosine, is an orally-active AKT inhibitor that is in several
Phase II trials for multiple cancers. AEterna Zentaris owns 50.7%
of Atrium Biotechnologies Inc. (ATB.sv), a leading developer,
manufacturer and marketer of value-added products for the
cosmetics, pharmaceutical, chemical and nutritional industries.
News releases and additional information about AEterna Zentaris are
available on its Web site http://www.aeternazentaris.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. DATASOURCE: AETERNA
ZENTARIS INC. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
CONTACT: Media Relations: Paul Burroughs, (418) 652-8525, ext. 406,
; Investor Relations: Ginette Vallieres, (418) 652-8525, ext. 265,
; Europe: Matthias Seeber, +49-6942602-3425, ; To request a free
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