Seattle Genetics has forged a special protocol agreement with the FDA for the pivotal study of SGN-35, an oncology drug. The biotech says that it plans to start the trial in the first quarter and hopes to gain an accelerated approval in 2011.
Under the agreement, Bothell, WA-based Seattle Genetics will recruit 100 patients who have had an autologous stem cell transplant. Researchers will gauge patients' response to the drug. Patients will receive 1.8 milligrams per kilogram of SGN-35 every three weeks. The primary endpoint of the trial will be objective response rate assessed by an independent radiographic facility. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability. The company plans to enroll patients at more than 30 sites in the U.S., Canada and Europe. A second, mid-stage trial of SGN-35 will also get underway in the first quarter for refractory systemic anaplastic large cell lymphoma, an immune system cancer involving white blood cells.
"The data thus far from both of our phase I trials of SGN-35 have exceeded our expectations, including multiple complete and partial responses at well-tolerated doses, suggesting that this agent may address a substantial unmet medical need in patients with relapsed or refractory Hodgkin lymphoma," says CEO Clay B. Siegall, Ph.D.
- here's Seattle Genetics' release
- check out the AP report