Ofatumumab is already on the list in phase 2. Here are details of the upcoming phase 2 trial. With all the discussion around rituxan lately, this one is promising because it goes after the same target as rituxan, CD20, and therefore, B cells.
Genmab Announces Details of Planned Ofatumumab Phase II Study in Multiple Sclerosis
COPENHAGEN, Denmark, Dec. 13, 2007 – Genmab A/S (OMX: GEN) announced today details of a planned Phase II study of ofatumumab (HuMax-CD20) 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 ofatumumab or placebo. After week 24, patients on an active dose will receive re-treatment with the same dose of ofatumumab or placebo. Patients on placebo will receive ofatumumab at the highest tolerated dose from Part A.
The objective of the study is to determine the safety and tolerability of three doses of ofatumumab and the dose response of ofatumumab on disease activity on MRI in patients with RRMS. The primary endpoints are safety and cumulative number of new Gd-enhanced lesions from week 8 to week 24.
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