QUÉBEC CITY, Feb. 20, 2013 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the "Company") today announced that a first patient
has been treated for the randomized Phase 2 trial in chemotherapy
refractory triple-negative ("ER/PR/HER2-negative") luteinizing
hormone-releasing hormone receptor ("LHRH-R")-positive metastatic
breast cancer, with the Company's targeted doxorubicin peptide
conjugate, AEZS-108. Alberto J. Montero, MD, Assistant Professor,
Department of Medicine, Division of Hematology/Oncology, Sylvester
Comprehensive Cancer Center at the University of Miami Miller School of
Medicine, is the lead investigator of this trial which also include
sites at the Universities of Regensburg and Goettingen, in Germany.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated,
"Patients with triple-negative breast cancer have poorer outcomes
compared to other breast cancer subtypes and are in need of a safe and
effective therapeutic regimen. Because LHRH receptors are expressed in
a majority of triple-negative breast cancers, we believe AEZS-108 could
represent a novel targeted treatment for these patients. Expansion into
the breast cancer indication with AEZS-108 after positive Phase 2
results in endometrial and ovarian cancer, as well as positive interim
Phase 1/2 results in prostate cancer, is further proof of the potential
of this innovative compound in a variety of cancer indications for both
women and men."
The Study
This is an open-label, randomized, two-arm, multicenter Phase 2 study
which will involve up to 74 patients. Patients will be randomized in a
1:1 ratio into one of the two treatment arms: AEZS-108 (267 mg/m2 every 21 days) [Arm A] or SSC (standard single agent cytotoxic
chemotherapy [Arm B]) at the discretion of the treating oncologist.
The primary study endpoint is median time of progression-free survival.
Secondary endpoints include overall response-rate, and overall
survival. The study will also evaluate AEZS-108's toxicity profile and
patients' quality of life relative to conventional cytotoxic
chemotherapy.
For more information on this trial, consult clinicaltrials.gov under NCT01698281.
About Breast Cancer and Triple-Negative Breast Cancer
According to the American Cancer Society, breast cancer is the most
prevalent form of cancer in women after skin cancers. In 2012, an
estimated 226,870 new cases of invasive breast cancer were diagnosed in
women in the U.S., and about 39,510 of them were expected to die from
this disease.
About 10% to 20% of breast cancers are triple-negative breast cancer
("TNBC"), a subtype of breast cancer that is clinically negative for
expression of estrogen and progesterone receptors ("ER/PR") and human
epidermal growth factor receptor-2 ("HER2"). It is characterized by its
unique molecular profile, aggressive behavior, distinct patterns of
metastasis, and lack of targeted therapies. Chemotherapy has been the
mainstay of treatment for women with TNBC, but this current
standard-of-care is suboptimal. Despite best available therapy, TNBC
continues to be associated with poorer outcomes when compared with
other breast cancer subtypes.
About AEZS-108 (doxorubicin peptide conjugate)
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 advanced clinical development that directs the chemotherapy agent
specifically to Luteinizing Hormone-Releasing Hormone ("LHRH")-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 ovarian and endometrial cancer and the
Company is currently planning a Phase 3 trial in endometrial cancer
under a Special Protocol Assessment. AEZS-108 is also in Phase 2 trials
in prostate, breast and bladder cancer. 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.