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Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)
Date:12/8/2008

e first infusion and 2,000 mg of ofatumumab at each subsequent infusion. Disease status is assessed every four weeks until week 28 and then every three months until disease progression or month 24.

The interim analysis included 138 treated patients (DR, n=59; BFR, n=79). Patient recruitment is ongoing and a final analysis will be conducted on the full study population, expected to be 100 patients in each group.

The primary endpoint of the study is objective response over a 24 week period from start of treatment as assessed according to the National Cancer Institute Working Group guidelines by an Independent endpoint Review Committee (IRC). Secondary endpoints included duration of response, progression free survival, time to next CLL therapy, overall survival and adverse events.

About ofatumumab

Ofatumumab is being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing-remitting multiple sclerosis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved for any indication in any country.

About CLL

CLL is the most common leukemia and one of the most common malignant lymphoid diseases.(2) Globally, leukemia accounts for some 300,000 new cases each year (2.8 percent of all new cancer cases) and 222,000 deaths.(7)

Conference Call

Genmab will hold a conference call to discuss these results tomorrow, December 9, 2008 at:

3:00 pm CEST

2:00 pm BST

9:00 am EST

The conference call will be held in English.

The dial in numbers are as follows:

+1 877 723 9518 (in the US) and ask for the Genmab conference call

+1 719 325 4812 (outside the US) and ask for the Genmab conference call <
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SOURCE GlaxoSmithKline
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