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Biotech / Medical : Seattle Genetics (SGEN) -- Ignore unavailable to you. Want to Upgrade?

To: Steve Lokness who wrote (117)	12/7/2007 11:08:50 AM
From: Steve Lokness	Read Replies (1) \| Respond to of 161

Is this what has been moving the stock? biz.yahoo.com Seattle Genetics Initiates SGN-40 Phase IIb Clinical Trial in Combination with Rituxan and Chemotherapy for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Friday December 7, 9:00 am ET Trial Initiation Triggers $12 Million Milestone Payment from Genentech BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN - News) announced today that it has initiated a phase IIb clinical trial of SGN-40 in combination with Rituxan® (rituximab) plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company’s collaboration agreement with Genentech, Inc., Seattle Genetics will receive a $12 million milestone payment for initiating the study. ADVERTISEMENT “This phase IIb clinical trial will provide key data on the safety and potential efficacy of adding SGN-40 to standard second-line therapy for the treatment of patients with relapsed diffuse large B-cell lymphoma,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “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.” The American Cancer Society estimates that more than 63,000 people will be diagnosed with NHL in the United States in 2007 and approximately 19,000 will die from the disease. The phase IIb, randomized, double-blind, placebo-controlled clinical trial, named SeaGen MARINER, is expected to enroll approximately 200 relapsed or refractory DLBCL patients at more than 60 medical centers worldwide. Patients will receive either Rituxan, ifosfamide, carboplatin and etoposide (R-ICE) plus SGN-40 or R-ICE plus placebo. The primary endpoint of the study is complete response rate. Additional endpoints include safety, tolerability, failure-free and overall survival. SGN-40 Development Program SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies including non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. CD40 is also found on many types of solid tumors, including bladder, renal and ovarian cancer. Under the terms of an exclusive worldwide collaboration agreement for the development and commercialization of SGN-40, Seattle Genetics and Genentech are executing on a development plan that includes initiating multiple clinical trials in non-Hodgkin’s lymphoma and multiple myeloma. 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 lenalidomide (Revlimid®) are ongoing. The companies plan to initiate three additional phase Ib clinical trials in combination with standard regimens for multiple myeloma and non-Hodgkin’s lymphoma by early 2008. Seattle Genetics received an upfront payment of $60 million in February 2007, and has the potential to receive milestone payments exceeding $800 million and escalating double-digit royalties starting in the mid-teens. In addition, Genentech funds research, development, manufacturing and commercialization costs, including reimbursing Seattle Genetics for its costs to conduct SGN-40 clinical trials and development activities