Summary: Genmab has Announced Details of a Planned Phase II Study of
Ofatumumab to Treat Relapsing Remitting Multiple Sclerosis
COPENHAGEN, Denmark, December 13 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today details of a planned Phase II study of ofatumumab (HuMax-CD20(R)) for the treatment of relapsing remitting multiple sclerosis (RRMS). Approximately 324 patients will be enrolled in the study which will be conducted under Genmab's collaboration with GlaxoSmithKline (GSK). The study is expected to begin in the first quarter of 2008.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
"Multiple sclerosis is a debilitating disease for which there are currently few treatments," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We hope our fully human antibody, ofatumumab, may offer another potential treatment option for patients suffering from this incapacitating disease."
About the trial
The double blind randomized trial will consist of two parts. Part A will include approximately 36 patients in one of three increasing dose cohorts (100 mg, 300 mg or 700 mg of ofatumumab) randomized to receive ofatumumab or placebo. An independent data monitoring committee (IDMC) will evaluate the safety of each sequential cohort prior to progression to the next cohort. When all patients in Part A have had their week 4 MRI scan, the IDMC will evaluate the data before Part B of the study begins.
Part B will consist of a 48 week treatment period of approximately 288
patients. Patients will be randomized to treatment with 100 mg, 300 mg, or
700 mg of ofatu
|SOURCE Genmab A/S|
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