QUÉBEC CITY, Oct. 25, 2011 /PRNewswire/ -Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today
announced that the U.S. Food and Drug Administration (FDA) has granted
Alberto J. Montero, M.D., Assistant Professor, Department of Medicine,
Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center
at the University of Miami Miller School of Medicine, an
Investigational New Drug (IND) approval for the initiation of a
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
cytotoxic LHRH analog, AEZS-108.
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 cancer, we believe AEZS-108 could
represent a novel targeted treatment for these patients. Expansion into
the breast cancer indication with AEZS-108 after recent positive Phase
2 results in endometrial and ovarian cancer, as well as positive 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 will be an open-label, randomized, two-arm, multicenter Phase 2
study involving up to 74 patients. Eligibility criteria include
histologically documented breast cancer (either primary or metastatic
site) that is ER-negative, PR-negative, HER2 non-overexpressing by
immunohistochemistry (0, 1) or fluorescence in situ hybridization (FISH); expression of LHRH-R receptor confirmed by IHC on
archival (or current biopsy of breast tumor or metastatic site) breast
cancer tissue; prior treatment that includes having received 1 to 3
prior chemotherapy regimens in the metastatic setting; and metastatic
breast cancer (Stage IV) with measurable disease by RECIST 1.1
criteria. 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 discretion of the treating oncologist.
The primary study endpoint will be median time to progression. Secondary
endpoints will also 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.
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 2011, an
estimated 230,480 new cases of invasive breast cancer are expected to
be diagnosed in women in the U.S., and about 39,520 of them are
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
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
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 endometrial and ovarian
cancer, and is also in Phase 2 trials in prostate and bladder cancer. A
pivotal trial in endometrial cancer is expected to be initiated by the
end of 2011. 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 Inc.
Aeterna Zentaris is a late-stage oncology drug development company
currently investigating potential treatments for various cancers
including colorectal, multiple myeloma, endometrial, ovarian, prostate
and bladder cancer. The Company's innovative approach of "personalized
medicine" means tailoring treatments to a patient's specific condition
and to unmet medical needs. Aeterna Zentaris' deep pipeline is drawn
from its proprietary discovery unit providing the Company with constant
and long-term access to state-of-the-art therapeutic options. 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.