Genmab's HuMax-CD4 achieves positive interim results in extended Phase II studies for CTCL
Copenhagen, Denmark. Genmab A/S announced it will present data from Phase II HuMax-CD4 studies to treat cutaneous T-cell lymphoma (CTCL) at the 65TH Annual Meeting of the Society for Investigative dermatology in April. At the time the abstract was completed, 36 patients enrolled in the two ongoing HuMax-CD4 clinical trials were evaluated using the Composite Assessment of Index Lesion Disease Activity (CA) score. These patients were treated at one of three dose levels as follows: 280 mg (11 early stage and 10 advanced stage), 560 mg (9 early stage) or 980 mg (6 advanced stage).
Following 280 mg, 33% of 21 patients obtained a 50% or better CA score reduction. Following 560 mg, 67% (six of nine early stage patients) obtained a CA score reduction of 50% or better, including two who obtained a 100% reduction. Three other early stage patients had stable disease. Following 980 mg, 50% (three of six) advanced stage patients obtained a CA score reduction of more than 50% and three patients had stable disease.
Following 280 mg dosing, 6 grade 3 adverse events were reported by 4 patients. 5 were unrelated to HuMax-CD4. Following 560 and 980 mg, 1 unrelated grade 3 adverse event was reported. No grade 4 events were reported. HuMax-CD4 has been found to be safe and well tolerated by patients with CTCL in clinical studies to date.
At present, 15 early stage patients are enrolled in the 560 mg treatment group and 10 late stage patients are enrolled in the 980 mg treatment group. At the time of the presentation on April 30, 2004, more complete data covering more of these patients for a longer period of time is expected to be available.
"The higher doses of HuMax-CD4 are showing a positive effect in these studies so far," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We are pleased because there is a need for new therapy for CTCL."
HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab is running two Phase II studies concurrently using HuMax-CD4 to treat cutaneous T-cell lymphoma (CTCL).
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