Press Center » Archived News Releases » 2001
Copenhagen, Denmark; January 9, 2001 - Genmab A/S (CSE: GEN
and Neuer Markt: GE9D) announced today that it has initiated a Phase II
clinical trial with its fully human antibody HuMax-CD4(TM) to treat patients
with severe psoriasis. This multi-center study will include four different
dose levels plus a placebo arm and it is designed to provide safety and
efficacy data, as well as dose finding information.
HuMax-CD4 Phase I/II results were presented at the American College of
Rheumatology meeting in Philadelphia in November and showed that the fully
human antibody was well tolerated and that patients' CD4 counts remained
stable in response to the treatment. In this single dose study, the four
highest dose cohorts, 0.5, 1, 2 and 4 mg/kg, fifty percent of the treated
patients achieved favorable responses to the antibody, as measured by
objective criteria defined by the American College of Rheumatology and
routinely used by companies seeking regulatory approval of arthritis
products. Eight of 16 achieved ACR 20, one of those achieved ACR 50, and two
of the group achieved ACR 70.
"Genmab has achieved another development milestone with the initiation
of this second Phase II study with HuMax-CD4," said Lisa. N. Drakeman,
Ph.D., Chief Executive Officer "Current treatments can be extremely
toxic to patients and new therapies are urgently needed for the millions of
people who suffer from psoriasis."
(back to Archived News)