Aeterna Zentaris: Preclinical Data for AEZS-108 in Bladder Cancer Published Online in Oncotarget

QUÉBEC CITY, July 26, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that preclinical data for the Company's targeted cytotoxic luteinizing hormone-releasing hormone (LH-RH) analog, AEZS-108 (formerly AN-152), in urinary bladder cancer, have been published in the online edition of Oncotarget. The article outlines AEZS-108's powerful growth inhibition of bladder cancers in nude mice, as well as its safety profile.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "Results of this study were the basis which warranted the development of AEZS-108 into the clinical stage and eventually led to the current Phase 2 trial in refractory bladder cancer conducted by lead investigator, Gustavo Fernandez, MD, of the University of Miami, Miller School of Medicine."

The Study

The study investigated the expression of LH-RH receptors in clinical bladder cancers and in HT-1376, J82, RT-4 and HT-1197 human bladder cancer lines. The effect of AEZS-108 on growth of these tumor lines xenografted into nude mice was analyzed. Molecular and functional assays were used to also evaluate differences between the effects of AEZS-108 and doxorubicin (DOX), the cytotoxic moiety of AEZS-108, alone. The study demonstrated the expression of LH-RH receptors on 18 clinical bladder cancers by immunohistochemistry and on four human urinary bladder cancer lines HT-1376, J82, RT-4 and HT-1197 by Western blotting and binding assays.

Results

AEZS-108 powerfully inhibited growth of these bladder cancers in nude mice, exerted greater effects than DOX and was less toxic. In contrast to DOX alone which activated strong multidrug resistance mechanisms in RT-4 and HT-1197 cancers, AEZS-108 had no or less such effects. PCR assays and in vitro studies revealed differences in the action of AEZS-108 and DOX on the expression of genes involved in apoptosis.

A copy of the article is available by clicking on this link

About Bladder Cancer

Bladder cancer refers to the development of abnormal cells that amass in the tissues of the bladder to form a malignant tumor. The most common type of bladder cancer, transitional cell carcinoma (or urothelial carcinoma), develops in the cells lining the inside of the bladder. In the U.S., urothelial carcinomas account for more than 90 percent of all bladder cancers.

In 2012, the National Cancer Institute estimates that 73,510 cases of bladder cancer will be diagnosed in the U.S. alone. The disease is more commonly found in males than females with approximately three times more men diagnosed each year. More than 70 percent of all patients with bladder cancer are older than 65.

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 LH-RH 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, bladder and breast cancer. A pivotal trial in endometrial cancer is expected to be initiated by the end of 2012. 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.