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Genmab Announces Positive Interim Data for the HuMax-CD20 Phase II RA Study

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Genmab Announces Positive Interim Data for the HuMax-CD20 Phase II RA Study

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1170052 & contentty\

pe=sentryarticle & channelID=29

COPENHAGEN, Denmark - Genmab A/S announced today positive results from an

interim analysis of the first 100 patients in the ongoing Phase II

rheumatoid arthritis (RA) study. A statistically significant proportion of

patients on active treatment obtained a 20% improvement of the American

College of Rheumatology (ACR) response compared to patients treated with

placebo.

Correspondingly, in all groups treated with HuMax-CD20, a greater proportion

of patients benefited from moderate or good EULAR responses compared to

placebo.

Rates of overall adverse events were comparable between the 3 groups of

patients receiving HuMax-CD20 these were primarily infusion related and do

not limit plans for continued development. Serious infections among treated

patients were confined to one event of bronchopneumonia in the 300 mg dose

group.

With this data in hand, Genmab will start planning Phase III studies. These

studies are expected to begin in 2007.

" The interim data are comparable to the Phase I/II RA data trial released

earlier this year and support our plan to move into Phase III with

HuMax-CD20 in RA, " said N. Drakeman, Ph.D., Chief Executive Officer of

Genmab. " Our fully human antibody should be suitable for treating

chronically ill patients and we look forward to continued development of

this potential alternative to available treatments. "

There are 226 patients enrolled in the Phase II study which completed

accrual in September. Genmab expects to present results for the full Phase

II study during the first half of 2007. This analysis was carried out to

assist in decision making and planning for the expected Phase III studies in

RA.

About the study

The study is a double-blind, randomized, placebo controlled, multicenter

Phase II trial for patients with active RA who have previously failed one or

more DMARDs. Patients were randomized to one of 4 treatment groups (300 mg,

700 mg or 1000 mg of HuMax-CD20 or placebo). Patients were permitted to

continue therapy with stable doses of methotrexate and low dose prednisolone

was also allowed. ACR and EULAR responses were assessed in the primary

intention-to-treat efficacy population at 24 weeks.

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