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Trials & Filings

Genmab Positive on Ofatumumab in Phase II

Trial showed no PML cases

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Genmab has reported top-line results from its Phase II study of the subcutaneous formulation of ofatumumab in relapsing-remitting multiple sclerosis (RRMS). The 232-patient trial showed 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.

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. To date, no cases of progressive multifocal leukoencephalopathy (PML) or opportunistic infections have been observed.

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