Genmab announced Humax-CD4 did not achieve statistically significant results in a 118 patient Phase IIb study to treat psoriasis. Analysis of the data indicated that Humax-CD4 was safe and well tolerated in the studies to date. There was also a statistically significant dose dependent depletion of CD4+ T-cells. Genmab has no further plans to develop Humax-CD4 for the treatment of psoriasis. Genmab is continuing its two Phase II studies with Humax-CD4 to treat cutaneous T-cell lymphoma after encouraging results were presented this fall.

Humax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab is also running two Phase II studies concurrently using Humax-CD4 to treat cutaneous T-cell lymphoma (CTCL). Interim results using the Physician's Global Assessment showed 55per cent of the early stage and 38per cent of the advanced stage CTCL patients achieved at least a partial response (more than 50per cent improvement in their disease). One early stage patient's CTCL was completely cleared. In addition, 9per cent of the early stage and 23per cent of the advanced stage patients achieved a minor response (25-50per cent improvement). In other measures of the disease state, pruritus (severe and sometimes debilitating itching) was improved in 82per cent of early stage patients and 69per cent of advanced stage patients. Pruritus is most likely the single major parameter for reducing quality of life in CTCL patients.

Genmab is adding patients to the Phase II CTCL studies at higher dose levels. The dose level has been increased from the original 280mg per week for 16 weeks in the ongoing studies because CD4+ T-cells were not fully depleted in the initial patients. The objective of using higher doses is to improve responses by further reducing the number of CD4+ T-cells and, thus, the number of cancer cells. At present, 10 early stage patients are being treated with 560mg per week and 7 advanced stage patients are being treated at the 980mg weekly dose level.

A review of the safety data has indicated that Humax-CD4 appears to have been safe and well tolerated in clinical trials to date. During the Phase II CTCL studies no Grade 4 adverse events have occurred. There have been only four Grade 3 adverse events and only one of those, skin hypersensitivity, was judged to be possibly treatment related. In addition to CTCL, approximately half of the non-cutaneous T-cell lymphomas express the CD4 receptor on their cell surface and Genmab has also treated a non-cutaneous T-cell lymphoma patient on a compassionate use basis with a good clinical effect.

Considering this and the encouraging data from the CTCL study, Genmab is now making plans to initiate a study in non-cutaneous T-cell lymphoma patients in the second half of 2004, especially since these patients also have a dramatic need for new and less toxic therapies.

Genmab is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases.