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To: Icebrg who wrote (770)	12/7/2003 5:37:48 PM
From: Icebrg	Read Replies (1) \| Respond to of 2240

Genmab's HuMax-CD4 Achieves Positive Results in T-Cell Lymphoma Phase II Studies Sunday December 7, 5:27 pm ET Summary: Genmab's HuMax-CD4 Achieves Positive Results in T-Cell Lymphoma Studies. COPENHAGEN, Denmark, Dec. 7 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN - News) announced today positive interim results in its two Phase II studies with HuMax-CD4 to treat cutaneous T-cell lymphoma (CTCL) that involved 11 early stage and 13 advanced stage patients. All 24 patients could be evaluated using the Physician's Global Assessment (PGA). This assessment showed 55% of the early stage and 38% of the advanced stage patients achieved at least a partial response (more than 50% improvement in their disease). One early stage patient's CTCL was completely cleared. In addition, 9% of the early stage and 23% of the advanced stage patients achieved a minor response (25-50% improvement). The PGA is a comparison to the patient's baseline condition by grading all cancerous lesions from 0 to 6. In addition, in other measures of the disease state, pruritus (severe and sometimes debilitating itching) was improved in 82% of early stage patients and 69% of advanced stage patients. Pruritus is most likely the single major parameter for reducing quality of life in CTCL patients. As previously announced, Genmab is adding patients to the Phase II 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. This brings the total patients in the two studies to 41. 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. "These results are very encouraging," said Lisa N. Drakeman, Ph. D., Chief Executive Officer of Genmab. "It is always good news when you can see a benefit to cancer patients, especially when the medical need is great." These data were presented today at the 45th Annual Meeting of the American Society of Hematology in San Diego, California. [Conference call information deleted] About the HuMax-CD4 studies Genmab is running two Phase II studies concurrently. One study is focused on early stage disease and the other is for patients with late stage CTCL, all refractory or intolerant to previous therapy. In both studies, the treatment regimen involves a 280mg dose of HuMax-CD4 once a week for 16 weeks. Patients are followed for at least 4 weeks after the end of treatment or until disease progression. The objective of the studies is to determine the efficacy and safety of HuMax-CD4 in the treatment of CTCL. Based on this encouraging interim analysis, Genmab has begun enrolling additional patients in both studies and increased the weekly dose from 280mg to 560mg for early stage patients and from 280mg to 980mg for patients with late stage disease. Treatment of these additional patients will continue for up to 16 weeks. The studies involving the original 24 patients also continue and a number of them have not yet received their entire course of therapy. About T-cell lymphomas and CTCL T-cell lymphomas positive for the CD4 receptor constitute around 5% of Non Hodgkin's Lymphomas. There are about 1,000 new cases of CTCL per year in the US and the prevalence of the disease is estimated at 16,000 to 20,000. CTCL patients tend to have a lifespan of 10 to 30 years and therefore could be treated several times during the disease progression. CTCL is one group of CD4+ lymphomas. This type of lymphoma expresses the CD4 receptor, which can be targeted by Genmab's HuMax-CD4 antibody. CTCL is a highly symptomatic disfiguring disease which is life threatening in the advanced stages and is incurable except at its very earliest stages. CTCL covers a range of diseases characterized by infiltration of the skin by malignant T-cells. This range of diseases includes Mycosis fungoides and the Sezary syndrome. Mycosis fungoides represents around 70% of all CTCLs. Most patients show symptoms even at the earliest stage of the disease with severe and sometimes debilitating itching and susceptibility to recurrent skin infections, and the majority suffer moderate to severe cosmetic disfigurement. In several groups of CTCL patients, defective apoptosis (or programmed cell death) has been documented, which may contribute to the difficulty of killing these types of tumors. An anti-CD4 antibody that depletes CD4+ cells in vivo has the potential to induce a clinical response.