Seattle Genetics begins phase 1/2 trial of SGN-40 for chronic lymphocytic leukemia

New York, Nov. 29 - Seattle Genetics, Inc. said it has started a phase 1/2 clinical trial of SGN-40 in patients with chronic lymphocytic leukemia.

The possible use is the company's third clinical indication for SGN-40, a humanized monoclonal antibody that targets the CD40 antigen. Seattle Genetics is also conducting phase 1 studies of SGN-40 in multiple myeloma and non-Hodgkin's lymphoma.

The Food and Drug Administration has granted orphan drug designation to SGN-40 for chronic lymphocytic leukemia.

"We believe that SGN-40 may be an important therapeutic in the treatment of many types of B-cell malignancies," said Clay B. Siegall, president and chief executive officer of Seattle Genetics, in a news release.

"Initiating this clinical trial in CLL [chronic lymphocytic leukemia] and receiving orphan drug designation are important accomplishments toward further expanding our opportunities for this program."

The single-agent phase 1/2 study will evaluate the tolerability, pharmacokinetic profile and antitumor activity of a multi-dose regimen of SGN-40 in relapsed or refractory chronic lymphocytic leukemia patients. The phase 1/2 study design allows rapid transition from the phase 1 dose-escalation portion into a phase 2 trial.

Seattle Genetics plans to enroll approximately 60 patients at multiple cancer centers in the United States.

Seattle Genetics is a Bothell, Wash., biotechnology company.

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