AEterna Zentaris Presents Phase 1 Results for AEZS-112 in Patients with Advanced Cancer and Lymphoma at AACR Annual Meeting in Denver
QUEBEC CITY, April 22, 2009 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. , a global biopharmaceutical company focused on endocrine therapy and oncology, today presented a poster outlining Phase 1 results for its orally-active tubulin and topoisomerase II inhibitor compound, AEZS-112, in patients with advanced solid tumors or lymphoma, which may potentially provide a new therapeutic approach for the treatment of cancer. The poster was presented at the American Association for Cancer Research (AACR) Annual Meeting in Denver, Colorado.
The poster (#5567) entitled, "Phase I dose-escalation, safety, and pharmacokinetic study on weekly oral AEZS-112, a small molecule anti-cancer agent in patients with advanced cancer and lymphoma", D.W. Northfelt, reviewed results of this Phase I study designed to evaluate the safety, tolerability and pharmacokinetics of ascending doses of AEZS-112 in patients with the above-mentioned forms of cancer.
In part I, 22 patients (12 men/10 women) were studied on 7 dose levels ranging from 13 to 800 mg/week. In all, 62 treatment cycles were administered. In part II, 22 patients (12 men/10 women) were studied on 5-dose levels ranging from 120 to 600 (=200x3) mg/week. As of April 1, 2009, 62 treatment cycles were administered (mean 3.2/patient); treatment was ongoing in 8 patients. Stable disease (SD) for more than 12 weeks was observed in 16 patients; 4 more patients were ongoing at less than 12 weeks. Prolonged courses of SD ranging from 20 to 39+ weeks were observed in 9 patients with the following primary cancer types: trachea (39+), tongue (30+), thyroid (29+), prostate and melanoma (28), non-small cell lung cancer (26+), pancreas and 2x colorectal (20).
Except for one patient with a background of gastrointestinal problems (GI) who had dose-limiting GI reactions and electrolyte loss at a dose of 200x3mg/week, no clinically relevant drug-related adverse events or changes in laboratory parameters were observed. AEZS-112 was shown to be metabolically stable in human plasma. As predicted by pharmacokinetic modelling based on data from part I of the study, the split-dose scheme leads to a higher Cmax and trough values after administration of comparable doses.
- AEZS-112 was well tolerated over repeated treatment courses; - So far, a maximum tolerated dose for weekly dosing has not been defined; and - Prolonged courses of stable disease in both parts of the study are an encouraging observation.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a 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.aezsinc.com.
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. 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 except if we are requested by a governmental authority or applicable law.
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Posted: April 2009