QUÉBEC CITY, Aug. 28, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that a first patient has been
recruited for a Phase 2A trial with its ghrelin agonist, AEZS-130
in patients with cancer cachexia. The study is conducted under a
Cooperative Research and Development Agreement (CRADA) between
Aeterna Zentaris and the Michael E. DeBakey Veterans Affairs
Medical Center which is funding the study. Cachexia, characterized
by diminished appetite and food intake in cancer patients, is
defined as an involuntary weight loss of at least 5% of the
pre-illness body weight over the previous 6 months.
Jose M. Garcia, MD, PhD, Assistant
Professor, Division of Diabetes Endocrinology and Metabolism,
Departments of Medicine, Molecular and Cell Biology, the
NCI-designated Dan L. Duncan Cancer Center and the Huffington
Center on Aging at Baylor College of
Medicine and Michael E. DeBakey Veterans Affairs
Medical Center, is acting as the Principal Investigator of this
trial conducted in Houston,
Texas.
Juergen Engel, PhD, President and
CEO of Aeterna Zentaris stated, "This is a key study as it allows
us to venture into the field of cancer-cachexia, an indication with
high unmet medical needs. Because cachexia is very common among
cancer patients, our oral ghrelin agonist, AEZS-130, could
represent a novel treatment option for many of the 1.5 million
people diagnosed with cancer each year, in the U.S. alone."
The Study
This is a double-blind, randomized, placebo-controlled Phase 2A
trial to test the effects of different doses of AEZS-130 in 18 to
26 patients with cancer-cachexia. AEZS-130 will be provided by
Aeterna Zentaris. The study will involve 3 sequential groups
receiving differing doses of AEZS-130. Each dose group will have 6
patients who will receive AEZS-130 and 2-4 patients who will
receive placebo. After analysis of safety and efficacy at each dose
level vs. placebo, a decision will be taken either to
decrease or increase the dose. For this study, adequate efficacy
will be defined as a ≥0.8 kg of body weight gain or a ≥50 ng/mL
increase in plasma IGF-1 levels. The primary objective of the study
is to evaluate the safety and efficacy of repeated oral
administration of AEZS-130 at different doses daily for 1 week in
view of developing a treatment for cachexia. The following
parameters will be recorded to assess efficacy during the study:
change of body weight, change of IGF-1 plasma levels, and change of
quality of life score (Anderson Symptom Assessment Scale, FACIT-F).
Other secondary objectives will include food intake, and changes in
the following: appetite, muscle strength, energy expenditure,
reward from food and functional brain connectivity.
About Cancer Cachexia
Over 1,500,000 new diagnoses of cancer are made in the U.S.
every year. In most cases, this condition can have a significant
impact on the individuals' survival and quality of life. Cachexia,
a complex metabolic syndrome associated with underlying illness, is
common in patients with cancer. These patients have diminished
appetite, food intake and insulin sensitivity all of which
contribute to a decrease in functional performance, take a heavy
toll on patients' quality of life and are associated with poor
survival.
Despite the significant burden that cachexia and other
cancer-related symptoms such as anorexia and poor functional status
represent to cancer patients, these symptoms often remain
undiagnosed and untreated. Moreover, there are currently no
approved treatments for cancer-related cachexia.
About AEZS-130
AEZS-130, a ghrelin agonist, is a novel orally-active small
molecule that stimulates the secretion of growth hormone by binding
to the ghrelin receptor (GHSR-1a). It can be used in both oncology
and endocrinology indications. In oncology, the compound is in a
Phase 2A trial in cancer induced cachexia. Since ghrelin agonists
such as AEZS-130 have been shown to stimulate food intake and
increase body weight in rats and mice, AEZS-130 could lead to
better quality of life for patients with cancer-induced
cachexia.
In endocrinology, final Phase 3 results for AEZS-130 have been
disclosed for use as a simple oral diagnostic test for adult growth
hormone deficiency (AGHD). AEZS-130 works by stimulating a
patient's growth hormone secretion, which normally only occurs
during sleep, after which a healthcare provider will measure how
well the body responds to that stimulation based on the patient's
growth hormone levels over a period of time. Low growth hormone
levels, despite giving an effective stimulating agent, confirm a
diagnosis of AGHD. AEZS-130 has been granted orphan-drug
designation by the FDA for use as a diagnostic test for growth
hormone deficiency. Aeterna Zentaris owns the worldwide rights to
AEZS-130 which, if approved, would become the first
orally-administered diagnostic test for AGHD.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. For more information please visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the U.S. 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, 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 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 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, unless
required to do so by a governmental authority or by applicable
law.
SOURCE AETERNA ZENTARIS INC.