Copenhagen, Denmark; December 5,
2006 - Genmab A/S (CSE: GEN) 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 Lisa 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 multi center
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.