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.