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www.fdanews.com/articles/69449-hgs-completes-patient-enrollment-in-phase-ii-trial-of-hgs-etr1

HGS Completes Patient Enrollment in Phase II Trial of HGS-ETR1

March 4, 2005

Human Genome Sciences has completed the enrollment and initial dosing of patients in a Phase II clinical trial of HGS-ETR1 (mapatumumab) in advanced non-Hodgkin's lymphoma.

The Phase II clinical trial is a multicenter, open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1, an agonistic human monoclonal antibody to TRAIL receptor 1, in patients with relapsed or refractory non-Hodgkin's lymphoma. Patients enrolled in the trial are receiving up to six cycles of treatment in the absence of disease progression, with HGS-ETR1 administered as an intravenous infusion once every 21 days.

The objectives of the study are to evaluate disease activity and tumor response to HGS-ETR1 in patients with advanced non-Hodgkin's lymphoma, to evaluate the safety and tolerability of HGS-ETR1, and to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis.