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

Front Line CLL, NHL and CLL Retreatment and Japanese Development Studies

Planned

COPENHAGEN, Denmark, August 25 /PRNewswire-FirstCall/ -- Genmab has announced plans to begin four studies of ofatumumab in chronic lymphocytic leukemia and non-Hodgkin's lymphoma.

Genmab A/S (OMX: GEN) announced today plans to begin four studies of ofatumumab in chronic lymphocytic leukemia (CLL) and follicular non-Hodgkin's lymphoma (NHL) this year.

"Genmab and GSK have worked diligently to expand the ofatumumab development program to maximize the value of the antibody for patients and shareholders since our collaboration began," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab."The new studies we are initiating this year will examine the potential of ofatumumab in Japan as well as a number of new treatment settings - retreatment, maintenance and front line with chlorambucil."

Phase III CLL front line chlorambucil combination This open-label, parallel-arm study will include 444 patients with previously untreated CLL.Patients in the study will be randomized to receive ofatumumab in combination with chlorambucil or chlorambucil alone.Patients receiving ofatumumab in combination with chlorambucil will receive one infusion of ofatumumab at 300 mg, one infusion at 1000 mg a week later, followed by up to 11 monthly infusions at 1000 mg.Patients will be evaluated for disease status one month following last treatment then every 3 months for 5 years.

The primary objective of the study is to evaluate the progression free survival of ofatumumab in combination with chlorambucil therapy versus chlorambucil therapy alone for the treatment of front line CLL.

Phase II CLL ofatumumab retreatment and maintenance treatment study This study will examine the retreatment and maintenance treatment of refractory CLL patients who participated in the ongoing Phase III CLL study and had disease progression following
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SOURCE Genmab A/S
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