Genmab Initiates Second Phase II Study With HuMax-CD4
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."
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