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Genmab Announces Upcoming Ofatumumab Studies
Date:8/25/2008

at least an objective response or stable disease during a 24 week treatment period of ofatumumab.Eligible patients will receive one infusion of ofatumumab at 300 mg followed by 7 once weekly infusions at 2000 mg. Maintenance treatment will consist of 24 once monthly infusions of 2000 mg of ofatumumab.The primary objective of this study is to estimate the proportion of objective responses over 52 weeks.

Phase II NHL ofatumumab retreatment and maintenance study This study will examine the retreatment and maintenance treatment of refractory follicular NHL patients who participated in the ongoing Phase III NHL study and had disease progression following at least 6 months objective response to or stable disease on ofatumumab.Eligible patients will receive one infusion of ofatumumab at 300 mg followed by 7 once weekly infusions at 1000 mg. Maintenance treatment will consist of one 1000 mg infusion every two months for two years.The primary objective of this study is to evaluate the safety of ofatumumab retreatment and maintenance treatment.

Phase I study in Japan This open-label study will include a maximum of 12 patients with relapsed/refractory follicular NHL and at least 1 CLL patient who will be divided into 2 cohorts of 3 or 6 patients each.Patients will receive one infusion of ofatumumab at 300 mg followed by seven weekly infusions of 500 or 1000 mg of ofatumumab.Safety at the 500 mg dose level of ofatumumab will be examined before progressing to the 1000 mg dose level.The primary objective of the study is to evaluate the safety and tolerability of ofatumumab in Japanese relapsed/refractory follicular NHL and CLL patients.The primary endpoint of the study is safety.

Ofatumumab is an investigational new generation human monoclonal antibody that targets a distinct, membrane proximal, small loop epitope (specific antibody binding site) of the CD20 molecule on B cells. Ofatumumab is being developed to treat chronic lymphocytic leukemia, follicular
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SOURCE Genmab A/S
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