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 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.
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
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.
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.
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.