Development Stage
  • •  Phase IIb randomized, double-blind, placebo-controlled trial of low-dose cytarabine with or without lintuzumab in patients    with acute myeloid leukemia (AML)
  • •  Phase II trial in combination with Velcade (bortezomib) in patients with myelodysplastic syndromes (MDS)

Description
Lintuzumab is a humanized anti-CD33 monoclonal antibody. CD33 is highly expressed on a number of hematologic malignancies, including AML, MDS and several myeloproliferative disorders, but has limited expression on normal cells.

Status
In February 2009, Seattle Genetics reached its enrollment goal of 210 AML patients in a phase IIb clinical trial of low-dose cytarabine plus lintuzumab or placebo. The trial enrolled patients 60 years and older and is designed to determine whether the addition of lintuzumab prolongs overall survival in older patients. Data from the trial are expected in the second quarter of 2010. In addition, an investigator-sponsored phase II clinical trial of lintuzumab in combination with Velcade for MDS is ongoing. Lintuzumab has orphan drug designation from the FDA and the European Medicines Agency for both AML and MDS.

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