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AEterna Zentaris (AEZS): FDA Grants IND to Investigator at University of Miami School of Medicine for Phase 2 Trial with AEZS-108 in Triple-Negative Breast Cancer


10/25/2011 11:25:31 AM

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.



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