Genmab has announced 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 per cent 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 Lisa N. Drakeman, PhD., CEO 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.