AEterna Zentaris Advances AN-152 Targeted Anti-Cancer Agent into Clinical Development QUEBEC CITY, Jan. 18 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the initiation of a company-sponsored Phase I dose-ranging study for its targeted anti-cancer agent AN-152, a novel cytotoxic conjugate which has the potential to selectively and specifically target certain types of cancer cells that express Luteinizing Hormone Releasing Hormones (LHRH) receptors (LHRH receptor positive tumors) and thereby may offer a better safety and efficacy profile as compared to the cytotoxic agent alone. The Phase I study, which will be conducted at university clinics in Gottingen and Frankfurt/Main in Germany, will evaluate the safety (including maximum tolerated dose and dose-limiting toxicity) and pharmacokinetics of intravenously-administered AN-152 in patients with LHRH receptor positive ovarian, endometrial or breast cancer. A high percentage of these cancers, in addition to hormone-refractory prostate cancer, are known to be LHRH receptor positive and, therefore, represent logical initial indications for AN-152. "The initiation of this study not only marks an important milestone in the development of AN-152, a novel therapeutic approach against cancer, but also provides yet another proof of the extremely successful collaboration between our Company and the laboratory of Nobel Laureate Dr. Andrew Schally at Tulane University in New Orleans", said Prof. Jurgen Engel, Executive Vice President, Global R&D and COO of AEterna Zentaris. AN-152 is a cytotoxic conjugate that is designed to achieve differential delivery, or targeting, of the cytotoxic agent to cancer vs. normal cells. In AN-152, doxorubicin (an FDA-approved cytotoxic agent) is chemically linked to an LHRH agonist, a modified natural hormone with affinity for the LHRH receptor. This design allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor positive tumors. Potential benefits of this targeted approach are several-fold, and include a more favorable safety profile with lower incidence and severity of side effects, as normal tissues are spared from toxic effects of doxorubicin. Doxorubicin use is associated with significant, frequently treatment-limiting cardiac toxicity. In addition, the targeted approach may enable treatment of LHRH receptor positive cancers that have become refractory to doxorubicin given in its non-targeted form. In preclinical studies conducted to date in several animal models of LHRH receptor positive human cancer, AN-152's anti-tumor activity and tolerability were shown to be superior to that of doxorubicin. As would be expected, AN-152 was not active or was significantly less active than doxorubicin in LHRH receptor negative cancer cell lines. AEterna Zentaris has in-licensed worldwide rights to AN-152 from Tulane University. AN-152 is the lead compound in a series of cytotoxic conjugates that are designed to target certain tumor cells expressing receptors for peptide hormones such as LHRH, bombesin and somatostatin. About AEterna Zentaris Inc. AEterna Zentaris Inc. is an oncology and endocrine therapy focused biopharmaceutical company with proven expertise in drug discovery, development and commercialization. The Company's broad, renewable product pipeline leverages five different therapeutic approaches, including LHRH antagonists and signal transduction inhibitors. The lead LHRH antagonist compound, cetrorelix, is currently marketed for in vitro fertilization under the brand name Cetrotide(R), and has successfully completed a broad Phase II program in endometriosis and benign prostatic hyperplasia (BPH). The lead signal transduction inhibitor compound, perifosine, is an orally-active AKT inhibitor that is in several Phase II trials for multiple cancers. AEterna Zentaris also owns 61.1% of Atrium Biotechnologies Inc., an international company that develops, manufactures and markets added-value active ingredients and specialty chemicals for the cosmetics, chemical, pharmaceutical and nutritional industries, as well as health and nutrition products. News releases and additional information about AEterna Zentaris are available on its new Web site http://www.aeternazentaris.com/ . Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which 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 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 the 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. DATASOURCE: AETERNA ZENTARIS INC. 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