QUEBEC CITY, June 25, 2015 /CNW Telbec/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company") announced today
that it has executed a definitive agreement with Ergomed PLC
("Ergomed"), pursuant to which Ergomed will manage the new,
confirmatory Phase 3 clinical study to demonstrate the efficacy of
Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for
use in evaluating adult growth hormone deficiency ("AGHD").
David A. Dodd, Chairman,
President and Chief Executive Officer of the Company remarked
regarding the selection of Ergomed, "We have great confidence in
Ergomed's ability to conduct our confirmatory clinical study of
Macrilen™ on schedule and within budget. Ergomed's
performance as our clinical research organization supporting our
pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin
in Endometrial Cancer) study with
zoptarelin doxorubicin in women with advanced, recurrent or
metastatic endometrial cancer has been excellent. We are
committed to Macrilen™ because of our confidence in its efficacy
and safety and the medical need for such a convenient test in the
absence of an FDA-approved diagnostic test for AGHD."
Miroslav Reljanovic, M.D., CEO of Ergomed said, "We are
delighted that Aeterna Zentaris has selected us to manage their
confirmatory study of Macrilen™. We have a strong and deep
working relationship with the Company's scientific staff and hold
them in the highest regard."
About the Study
The confirmatory Phase 3 clinical study of Macrilen™ will be
conducted as a two-way crossover study with the insulin tolerance
test as the benchmark comparator. The study population will
consist of patients with a medical history documenting risk factors
for AGHD and will include a spectrum of patients from those with a
low risk of having AGHD to those with a high risk of having the
condition. Based on meetings with the US FDA as well as the
European Medicines Agency (the "EMA") and subsequent written
scientific advice, the Company believes that the study meets FDA's
and EMA's study-design expectations allowing US and European
approval, if successful.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small
molecule that stimulates the secretion of growth hormone.
Macimorelin, under the trade name MacrilenTM, has
been granted orphan drug designation by the FDA for diagnosis of
AGHD. The Company owns the worldwide rights to this novel
patented compound.
About Adult Growth Hormone Deficiency (AGHD)
AGHD affects approximately 75,000 adults across the U.S.,
Canada and Europe. Growth hormone not only plays an
important role in growth from childhood to adulthood, but also
helps promote a hormonally-balanced health status. AGHD
mostly results from damage to the pituitary gland. It is
usually characterized by a reduction in bone mineral density, lean
body mass, exercise capacity, and overall quality of life.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. For more
information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995. Forward-looking statements
involve known and unknown risks and uncertainties that 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 and clinical trials, the successful and
timely completion of clinical studies, the risk that safety and
efficacy data from any of our Phase 3 trials may not coincide with
the data analyses from previously reported Phase 1 and/or Phase 2
clinical trials, the ability of the Company to efficiently
commercialize one or more of its products or product candidates,
the ability of the Company to take advantage of business
opportunities in the pharmaceutical industry, uncertainties related
to the regulatory process, the potential inability to protect our
intellectual property, the potential of liability arising from
shareholder lawsuits and general changes in economic conditions.
Investors should consult the Company's quarterly and annual
filings with the Canadian and US securities commissions for
additional information on risks and uncertainties relating to
forward-looking statements. Investors are cautioned not to place
undue reliance 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, unless required to do so by
a governmental authority or by applicable law.
SOURCE Aeterna Zentaris Inc.