Copenhagen, Denmark; December 13, 2004 – Genmab A/S (CSE:
GEN) announced today the US Food and Drug Administration (FDA) accepted its
Investigational New Drug Application (IND) to start a Phase I/II dose
escalation trial for HuMax-CD20 to treat patients with active rheumatoid
arthritis (RA) who have failed one treatment with one or more disease
modifying anti-rheumatic drugs (DMARDs).
A total of 60 patients will be randomized into three cohorts each
containing 20 patients. In each cohort 16 patients will receive two
infusions of HuMax-CD20 (300, 700 or 1000 mg doses) and 4 patients will
receive placebo given 14 days apart. All patients in the study will
also receive methotrexate, a recognized
treatment in the US for RA. Patients will be followed for 24 weeks to
evaluate safety and efficacy and then every 12 weeks until B-cell counts
return to baseline levels. Genmab plans to initiate the study during
the early part of 2005.
About HuMax-CD20
HuMax-CD20 is a human antibody which is effective at binding to the disease
target, and releases only very slowly from the target over time. In
December 2004 Genmab presented positive data from a Phase I/II trial with
patients with relapsed or refractory follicular lymphoma showing 55% of
patients treated with HuMax™-CD20 achieved a clinical response in the Phase
I/II study, including two complete responses and one unconfirmed complete
response for a 27% complete response rate. These responses were observed in
11 evaluable patients among the first 15 of the
40 patients included in this study at the week 11 evaluation point. Further
details can be found in the press release from December 4, 2004 on the
press center site at www.genmab.com
A Phase I/II trial to treat patients with Chronic Lymphocytic Leukemia is
ongoing.
About CD20
The CD20 antigen is a transmembrane protein on
pre-B and mature B lymphocytes. CD20 appears to act as a calcium ion
channel, and to regulate early steps in B lymphocyte activation. The
molecule is not shed from the cell surface, and is not internalized upon
antibody binding. CD20 is found on over 90% of B-cell lymphomas, as well as
other lymphoid tumors of B-cell origin.
About RA
Rheumatoid arthritis (RA) is a systemic inflammatory disease which affects
0.8-1.0% of all populations. The aetiology of
RA remains unknown.