The committee evaluated the first ten patients enrolled to the phase II trial of PDX in patients with relapsed or refractory peripheral T-cell lymphoma who had completed one cycle of treatment with PDX, and has recommended that the trial continue. No major patient safety concerns were identified by the DMC.
Paul Berns, president and CEO of Allos, said: “We are pleased with the DMC’s recommendation and are grateful for the support received from our employees, investigators and patients who enabled us to reach this milestone.”
In accordance with the study’s design, an interim analysis of efficacy data will be conducted after 35 patients have completed one cycle of treatment with PDX, which is currently expected to occur in the second half of 2007.