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so it’s impossible to accurately compare it to how patients would have done on other treatment. Based on this data, Seattle Genetics plans to start a more rigorous final-stage clinical trial program in the first half of 2009 that could lead to FDA approval to market SGN-35 as its first commercial product.
Getting the clinical trial plan properly designed to make sure SGN-35 is a success has been a top priority of the company for months, as I described in this profile in September with chief medical officer Tom Reynolds. The company has geared up, hiring 65 new employees this year to help do this right, says spokeswoman Peggy Pinkston.
The SGN-35 results overshadowed another data release from Seattle Genetics at the same medical meeting. The company said another antibody it’s developing, SGN-40 or dacetuzumab, caused complete or partial tumor shrinkage in about 10 percent of 38 patients in a clinical trial. The patients were elderly (median age, 72) and very sick, having had a median of four prior rounds of chemotherapy to treat an aggressive form of lymphoma called diffuse large B-Cell lymphoma.
The SGN-40 drug is different from others on the market for lymphoma, like Genentech and Biogen Idec’s rituximab (Rituxan), because it’s designed to hit a different protein target called CD-40. Seattle Genetics is developing the product in a partnership with Genentech (NYSE: DNA). Separately, the companies said they found in animal tests that a combination of rituximab and the newer product was better at treating cancer than either drug on its own. Seattle Genetics and Genentech are running three separate clinical trials of combinations of SGN-40 to see which is most promising, Reynolds said in a statement.
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