In accordance with the study design, in September 2007, an interim analysis of patient response and safety data was conducted based on the first 35 patients enrolled to the study who completed at least one cycle of treatment with PDX. The results of the interim analysis of patient response data exceeded the pre-specified threshold for continuation of the trial, which required a minimum of four responses (complete or partial) out of the first 35 evaluable patients, as determined by independent oncology review. In addition, the Data Monitoring Committee identified no major safety concerns and recommended that the trial continue per the protocol.
Pablo Cagnoni, senior vice president and chief medical officer of Allos, said: “We remain pleased with the progress of the Propel trial and look forward to continuing to drive our PDX product development and commercialization plans in 2008.”