Genmab presents details of Phase II multiple sclerosis study

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 relapsing remitting multiple sclerosis (RRMS). The primary endpoints are safety and cumulative number of new Gd-enhanced lesions from week 8 to week 24.

The double blind randomized trial will consist of two parts. Part A will include approximately 36 patients in one of three increasing dose cohorts (100mg, 300mg or 700mg 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 100mg, 300mg, or 700mg 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.

Approximately 324 patients will be enrolled in the study which will be conducted under Genmab’s collaboration with GlaxoSmithKline. 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.