Cellcor Inc. received approval to expand into Canada its Phase III trialof autolymphocyte therapy (ALT) in metastatic kidney cancer, and thefirst patient already has been treated at the Jewish General Hospital inMontreal.The trial, which is ongoing at 30 sites in the U.S., is designed toevaluate survival of patients who receive either ALT or alphainterferon. "There are also secondary endpoints of tumor response,quality of life and cost effectiveness," Richard D'Antoni, president andCEO of the Newton, Mass, company, told BioWorld.He said about 25 percent of the 180 patients anticipated in the trialhave been accrued. An earlier 90-patient Phase III randomized trialshowed ALT extended survival to an average of 21 months vs. ninemonths in the cimetidine control arm.Currently, there is no approved treatment in Canada for metastatickidney cancer. Proleukin (IL-2), from Chiron Corp., of Emeryville,Calif., is the only approved drug for that indication in the U.S.D'Antoni said Proleukin's use is limited because of its side effects.ALT involves the activating a patient's own white blood cells in vitroin the presence of a rich mixture of autologous cytokines and anti-CD3monoclonal antibodies. Patients' cells are sent to Cellcor's cellprocessing facility near Boston for activation, then sent back to beinfused in the patient.D'Antoni said a significant aspect of the approval involved the workthat went into getting permission from health and customs officials totransport blood between the countries. "To our knowledge," he said,"this is the first time a cellular therapy in a clinical trial is beingtransported across borders." _ Jim Shrine
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