is halting development of lintuzumab after the experimental cancer drug failed to prolong survival in leukemia patients, according to results from phase III study announced Monday.
In the study of elderly patients with acute myelogenous leukemia (AML), treatment with lintuzumab plus a relatively mild, low-dose chemotherapy failed to boost survival compared to treatment with a placebo plus the chemo regimen alone.
While a setback for Seattle Genetics, the failure of lintuzumab was not unexpected given the aggressive nature of AML and the fact that a myriad of drugs aimed at benefiting elderly patients with this form of leukemia have likewise failed to produce a survival benefit.
"We're disappointed about the data, but this was the right study, it was executed very well and gave us a clear answer," said Seattle Genetics CEO Clay Siegall, in an interview conducted Sunday afternoon.
Seattle Genetics shares closed Friday at $12.72. Most investors who own the stock or follow it have viewed lintuzumab as a long shot. Much more attention is being paid to Seattle Genetics' lead cancer drug, SGN-35, which is expected to have data from two important clinical trials report within six weeks.
If positive, Seattle Genetics will be in a position to seek regulatory approval for SGN-35 in the first half of 2011, said Siegall.
SGN-35 is being studied in advanced Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). The Japanese drug maker
is Seattle Genetics' development and marketing partner for SGN-35.
Acute myelogenous leukemia, AML, is a fast-growing cancer that affects the blood and bone marrow. Lintuzumab is a naked monoclonal antibody that targets the CD33 antigen on the surface of tumor cells.
By contrast, SGN-35 is a monoclonal antibody attached to a chemotherapy payload.
is expected to begin a phase III study of its drug sapacitabine in elderly AML patients later this year.
--Written by Adam Feuerstein in Boston.
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