dadstimeon Posted January 9, 2007 Share Posted January 9, 2007 small molecule oral anti-cancer drug - IND accepted by FDA http://www.pipelinereview.com/joomla/co ... /9089/110/ AEterna Zentaris Initiates Phase 1 Trial for ZEN-012, a new small molecule oral anti-cancer drug - IND accepted by FDA 08 Jan 2007 Announced the initiation of the Company’s Phase 1 trial with its small molecule oral anti-cancer drug, ZEN-012, in patients with solid tumors and lymphoma, after the Company’s Investigational New Drug (IND) application was accepted by the U.S. Food & Drug Administration (FDA) in late December 2006. QUEBEC, Canada | Jan 08, 2007 | Æterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the initiation of the Company’s Phase 1 trial with its small molecule oral anti-cancer drug, ZEN-012, in patients with solid tumors and lymphoma, after the Company’s Investigational New Drug (IND) application was accepted by the U.S. Food & Drug Administration (FDA) in late December 2006. This open-label, dose-escalation, multi-center, intermittent treatment Phase 1 trial is being conducted in the United States under the supervision of lead investigator, Daniel D. Von Hoff, MD, Senior Investigator at the Translational Genomics Research Institute in Phoenix, Arizona. The trial will include up to 50 patients with advanced solid tumors and lymphoma who have either failed standard therapy or for whom no standard therapy exists. Patients will receive a once-a-week, oral administration of ZEN-012 for three consecutive weeks, followed by a one-week period without treatment. The cycles are to be repeated every four weeks based on toxicity and response, for up to four cycles. The starting dose of ZEN-012 will be 13 mg/week, with dose-escalation in subsequent cohorts depending on toxicity. Once the maximum tolerated dose (MTD) is established, up to 12 additional patients will be enrolled at the MTD level to further evaluate the safety of ZEN-012 at that dose level. Primary endpoints of the Phase 1 trial will focus on determining the safety and tolerability of ZEN-012 as well as establishing the recommended Phase 2 dose and regimen. Secondary endpoints are aimed at establishing the pharmacokinetics and determining the efficacy based on standard response criteria. "Preclinical data has shown that ZEN-012 has favorable safety and toxicity profiles with strong in vivo activity as well as efficacy in multi-drug resistant tumor cell lines," said Dr. Jürgen Engel, Executive Vice President, Global R&D and Chief Operating Officer at Æterna Zentaris. "With this Phase 1 trial, we hope to show that simultaneous inhibition of multiple targets may lead to tumor stabilization and regression. Taking into account the multiple mechanisms of action witnessed in our pre-clinical programs, we believe this compound has the potential to be a novel, promising multi-targeted oral intermittent cancer therapy." Gilles Gagnon, President and Chief Executive Officer at Æterna Zentaris added, "We are excited about initiating this trial, since ZEN-012 is part of an internally developed new class of oral compounds in oncology. Furthermore, this is a key element of our strategy aimed at establishing a risk-adverse profile by targeting earlier stage compounds with high potential for aggressive development, as we continue to build our solid endocrinology and oncology franchises." About ZEN-012 ZEN-012 is a novel small molecule and the first anti-cancer drug in development involving two mechanisms of action: tubulin and topoisomerase II inhibition. ZEN-012 also expresses additional modes of action such as pro-apoptotic and anti-angiogenic properties. ZEN-012 has shown potent in vitro anti-proliferative activity at nanomolar concentrations against human tumor cell lines of different origin. ZEN-012 is active in tumor cell lines which are resistant to cisplatin and doxorubicin as well as to tubulin inhibitors such as vincristine and paclitaxel. Furthermore, it was shown that ZEN-012 is a catalytic inhibitor of the enzyme topoisomerase II with the same potency as amsacrine. Given orally once or twice weekly, ZEN-012 proved to be a potent inhibitor of in vivo tumor growth in different models including mammary, colon, skin, lung, renal and leukemic cancers. About Æterna Zentaris Inc. Æterna Zentaris Inc. is a growing global biopharmaceutical company focused on endocrine therapy and oncology with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at 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. 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