Aeterna Zentaris: First Patient Treated for Phase 2 Trial with AEZS-108 in Triple-Negative Breast Cancer

  Aeterna Zentaris: First Patient Treated for Phase 2 Trial with AEZS-108 in
                        Triple-Negative Breast Cancer

PR Newswire

QUÉBEC CITY, Feb. 20, 2013

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/m^2 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.

Contact:

Investor Relations
Ginette Beaudet Vallières
Investor Relations Coordinator
(418) 652-8525 ext. 265
gvallieres@aezsinc.com

Media Relations
Paul Burroughs
Director of Communications
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
 
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