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

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.