QUEBEC CITY, April 22 /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.
Results
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.
Conclusions
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.
Forward-Looking Statements
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CONTACT: Investor Relations: Ginette Vallieres, Investor Relations
Coordinator, (418) 652-8525, ext. 265, gvallieres@aezsinc.com; Media
Relations: Paul Burroughs, Director of Communications, (418) 652-8525, ext.
406, pburroughs@aezsinc.com
