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Thursday, October 31, 2013

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

October 10, 2013

Genmab Announces Positive Top-Line Phase II Results of Ofatumumab in Multiple Sclerosis
  • 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.
We are encouraged by the results from this study, which we believe underline the potential of subcutaneous ofatumumab for treatment of relapsing-remitting multiple sclerosis, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study

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