QUÉBEC CITY, July 26, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that preclinical data for the
Company's targeted cytotoxic luteinizing hormone-releasing hormone
(LH-RH) analog, AEZS-108 (formerly AN-152), in urinary bladder
cancer, have been published in the online edition of
Oncotarget. The article outlines AEZS-108's powerful growth
inhibition of bladder cancers in nude mice, as well as its safety
profile.
Juergen Engel, PhD, President and
CEO of Aeterna Zentaris stated, "Results of this study were the
basis which warranted the development of AEZS-108 into the clinical
stage and eventually led to the current Phase 2 trial in refractory
bladder cancer conducted by lead investigator, Gustavo Fernandez, MD, of the University of Miami, Miller School of
Medicine."
The Study
The study investigated the expression of LH-RH receptors in
clinical bladder cancers and in HT-1376, J82, RT-4 and HT-1197
human bladder cancer lines. The effect of AEZS-108 on growth of
these tumor lines xenografted into nude mice was analyzed.
Molecular and functional assays were used to also evaluate
differences between the effects of AEZS-108 and doxorubicin (DOX),
the cytotoxic moiety of AEZS-108, alone. The study demonstrated the
expression of LH-RH receptors on 18 clinical bladder cancers by
immunohistochemistry and on four human urinary bladder cancer lines
HT-1376, J82, RT-4 and HT-1197 by Western blotting and binding
assays.
Results
AEZS-108 powerfully inhibited growth of these bladder cancers in
nude mice, exerted greater effects than DOX and was less toxic. In
contrast to DOX alone which activated strong multidrug resistance
mechanisms in RT-4 and HT-1197 cancers, AEZS-108 had no or less
such effects. PCR assays and in vitro studies
revealed differences in the action of AEZS-108 and DOX on the
expression of genes involved in apoptosis.
A copy of the article is available by clicking on this link
About Bladder Cancer
Bladder cancer refers to the development of abnormal cells that
amass in the tissues of the bladder to form a malignant tumor. The
most common type of bladder cancer, transitional cell carcinoma (or
urothelial carcinoma), develops in the cells lining the inside of
the bladder. In the U.S., urothelial carcinomas account for more
than 90 percent of all bladder cancers.
In 2012, the National Cancer Institute estimates that 73,510
cases of bladder cancer will be diagnosed in the U.S. alone. The
disease is more commonly found in males than females with
approximately three times more men diagnosed each year. More than
70 percent of all patients with bladder cancer are older than
65.
About AEZS-108
AEZS-108 represents a new targeting concept in oncology using a
hybrid molecule composed of a synthetic peptide carrier and a
well-known chemotherapy agent, doxorubicin. AEZS-108 is the first
intravenous drug in a clinical study that directs the chemotherapy
agent specifically to LH-RH receptor expressing tumors,
resulting in more targeted treatment with less damage to healthy
tissue. The product has successfully completed Phase 2 studies for
the treatment of endometrial and ovarian cancer, and is also in
Phase 2 trials in prostate, bladder and breast cancer. A pivotal
trial in endometrial cancer is expected to be initiated by the end
of 2012. AEZS-108 has been granted orphan drug designation by the
FDA and orphan medicinal product designation from the European
Medicines Agency for the treatment of ovarian cancer. Aeterna
Zentaris owns the worldwide rights to AEZS-108.
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.