Seattle Genetics Begins Phase II Clinical Trial of Treatment for Large B-Cell Lymphoma.
Seattle Genetics Inc. has initiated a phase II clinical trial of SGN-40 for the treatment of patients with diffuse large B-cell lymphoma, the most common type of aggressive non-Hodgkin's lymphoma (NHL).
The company said positive phase I data was reported last week at the American Society of Hematology annual meeting demonstrating that SGN-40 is well-tolerated and induces objective antitumor activity in patients with relapsed or refractory NHL.
Out of 31 evaluable patients, five (16%) had measurable objective responses, including one complete response ongoing after 41 weeks. Four patients achieved partial responses, three of which remain durable at 10, 18 and 31 weeks. Three of the five responses were in patients with diffuse large B-cell lymphoma. Eight additional patients (26%) had stable disease at the end of treatment. SGN-40 was well-tolerated using a dose-loading schedule and no dose-limiting toxicity or immunogenicity was identified.
"Advancing SGN-40 into mid-stage clinical trials is a significant milestone for Seattle Genetics," said Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics. "Relapsed and refractory aggressive NHL represents an important market opportunity for SGN-40 because currently available treatment options inadequately address the needs of this patient population."
The single-agent phase II study is designed to assess the antitumor activity, tolerability and pharmacokinetic profile of SGN-40 in patients with relapsed or refractory diffuse large B-cell lymphoma. The trial is expected to enroll up to 40 patients at multiple centers in the United States.
In addition to the diffuse large B-cell lymphoma study, SGN-40 is in phase I clinical trials for relapsed/refractory multiple myeloma and chronic lymphocytic leukemia. The company is also planning combination studies in NHL and multiple myeloma to begin in 2007.
For more information, visit www.seattlegenetics.com.
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|Date:||Dec 20, 2006|
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