Seattle starts Phase IIb trial of SGN-40

Dec. 10, 2007 - PRLog -- Seattle Genetics (Bothell, Washington) has begun a Phase IIb clinical trial of its monoclonal antibody SGN-40 as an adjunct to second-line therapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).  Under the terms of its worldwide collaboration agreement with Genentech, Seattle Genetics will receive a $12 million milestone payment for starting the study.

The randomised, double-blind, placebo-controlled trial – named  SeaGen MARINER - is expected to enroll approximately 200 patients at around 60 sites worldwide.  Patients will receive either Rituxan (rituximab), ifosfamide or carboplatin and etoposide (R-ICE) plus SGN-40, or R-ICE plus placebo.  The primary endpoint is complete response rate.  Additional endpoints include safety, tolerability, failure-free and overall survival.

SGN-40 is a humanised mAb that targets the CD40 antigen, which is expressed on most B lineage haematologic malignancies, including non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukaemia.  CD40 is also found on many types of solid tumour, including bladder, renal and ovarian cancer.

In addition to the SeaGen MARINER trial, a Phase II single-agent trial of SGN-40 in DLBCL and a phase Ib trial of SGN-40 in combination with Revlimid (lenalidomide) are ongoing.  The companies plan to begin three additional phase Ib clinical trials in combination with standard regimens for multiple myeloma and non-Hodgkin’s lymphoma by early 2008.

“We are moving forward with this global trial based on the encouraging safety profile and clinical activity observed in our phase I single-agent trial in patients with DLBCL, together with preclinical data demonstrating enhanced efficacy of SGN-40 when combined with chemotherapy,” said Seattle Genetics president and CEO Dr Clay B Siegall. Submitted by www.jobs4dd.com, for the latest news and jobs in the drugs development industry.

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