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Saturday, October 12, 2013

Genmab Announces Positive Top-Line Phase II Results of Ofatumumab in Multiple Sclerosis

Oct 10, 2013

Genmab A/SCompany AnnouncementGenmab Announces Positive Top-Line Phase II Results of Ofatumumab in Multiple
SclerosisCompany Announcement

  -- Treatment with ofatumumab showed significant reduction in the cumulative
     number of new brain lesions
  -- No unexpected safety findings

Copenhagen, Denmark; October 10, 2013 -- Genmab A/S (OMX: GEN) announced today
top-line results from a Phase II study of the subcutaneous formulation of
ofatumumab in relapsing-remitting multiple sclerosis (RRMS).

A total of 232 subjects with RRMS were randomized in the study.  There was a
clear separation from placebo on the cumulative number of new gadolinium
enhancing lesions (active brain lesions) over a period of 12 weeks in subjects
treated with all doses of ofatumumab compared to subjects treated with placebo
[p < 0.001].  For the primary endpoint, analysis of data from weeks 0-12
estimated a 65% reduction in the cumulative number of new T1 gadolinium
enhancing lesions for all doses [p < 0.001].  In weeks 4-12, analyses of data
estimated a >= 90% reduction in the cumulative number of new T1 gadolinium
enhancing lesions for all cumulative doses of ofatumumab >= 30 mg [p < 0.001].

There were no unexpected safety findings in the study.  From weeks 0-12,
injection related reactions were the most common adverse reaction and were
observed in 52% of subjects receiving ofatumumab compared to 15% of subjects
receiving placebo. There were five serious adverse events (SAEs) reported, all
subjects received a 60 mg dose of ofatumumab and none of these subjects
withdrew from the study. Twelve subjects withdrew during this time period; 10
of these subjects were receiving ofatumumab.  To date, no cases of progressive
multifocal leukoencephalopathy (PML) or opportunistic infections have been
observed.

Read more

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