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www.fdanews.com/articles/100913-seattle-genetics-begins-trial-of-sgn-33-for-aml

Seattle Genetics Begins Trial of SGN-33 for AML

November 9, 2007

Seattle Genetics has started a Phase IIb clinical trial of SGN-33, a monoclonal antibody, in combination with a low-dose regimen of the chemotherapeutic agent cytarabine for patients with acute myeloid leukemia (AML).

The multinational, randomized, double-blind, placebo-controlled study will assess whether SGN-33 (lintuzumab) combined with cytarabine extends survival compared with cytarabine alone in previously untreated patients 60 years of age and older.

The primary endpoint of the study is overall survival. Secondary endpoints include safety and tolerability, pharmacokinetics and hematologic function, including blood counts, transfusion requirements and quality of life, Seattle Genetics said.