Seattle Genetics will report results today at ASH Meetings of its clinical trials with SGN-35 (brentuximab vedotin) on relapsing Hodgkin's disease patients. In the latest clinical trial, 94 percent of the patents had at least some observable tumor shrinkage - 75% saw at least 50% shrinkage and 34% went into complete remission. Side effects were mostly mild compared to conventional chemotherapy.
The results are being hailed as groundbreaking by company officials and some clinicians involved in the clinical trials. This is the first success of a so-called empowered antibody (antibody drug conjugate) and is being closely watched in the industry. Seattle Genetics plans to file an application with the FDA by the end of March seeking approval. About 1/3 of the 8500 patients diagnosed with Hodgkin's will relapse at some point during their treatment. Seattle Genentics is aready talking about testing the hypothesis that the drug has the potential to be the standard of care with chemotherapy for 100% of newly diagnosed Hodgkin's patients.
Seattle Genetics controls 100% of the commercial rights in the US.If approved, Seattle Genetics will have its first product on the market and will begin to transform itself from and R&D organization to a more fully integrated commercial one. By the end of 2011, the company expects to add a commercial team numbering 110 and overall staffing could grow to 475-500 employees in the next 12 months.
"We want to be the next Celgene, the next Genzyme, the next really important biotech company," said Clay Siegall, Seattle Genetics CEO.
Posted by Bruce Lehr December 6th 2010.