Monday, June 18, 2007

Genmab to start Phase III studies of HuMax-CD20 in rheumatoid arthritis

06.18.07, 9:18 AM ET

COPENHAGEN (Thomson Financial) - Genmab AS said it expects to initiate Phase III studies of ofatumumab (HuMax-CD20) in rheumatoid arthritis (RA) by the end of 2007.

HuMax-CD20 is is being developed under a worldwide co-development and commercialisation agreement between Genmab and GlaxoSmithKline (nyse: GSK - news - people ).

Genmab said the group also plans to expand the development programme through a Phase II study in relapsing remitting multiple sclerosis (RRMS) in the first quarter of 2008.

There is potential to pursue indications in a wide range of autoimmune disease settings,' Genmab said.

The Danish pharma group added the development plans for ofatumumab will be described at GSK's Oncology Seminar.

Ofatumumab is currently in late stage development for chronic lymphocytic leukemia (CLL), follicular non-Hodgkin's lymphoma (NHL) and in Phase II for RA.

Genmab said a clear demonstration of the efficacy and safety of ofatumuamb in two late stage trials for CLL and follicular NHL could provide the initial regulatory applications.

The company has received a Fast Track designation for the CLL study.

Under these circumstances, it said, 'ofatumumab could potentially enter the market in 2008 first for the treatment of refractory CLL and subsequently for rituximab-refractory follicular NHL.'

The group has planned initiation of clinical studies for ofatumumab in diffuse large B-cell lymphoma (DLBCL) by the end of 2007 and randomised Phase III studies in CLL and follicular NHL in the first half of 2008.

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