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To: Icebrg who wrote (786)	2/18/2004 7:33:28 AM
From: Icebrg	Read Replies (1) \| Respond to of 2240

GENMAB TO PRESENT HUMAX-CD4 DATA AT THE SOCIETY FOR INVESTIGATIVE DERMATOLOGY CONFERENCE 67% of Early Stage and 50% of Advanced Stage Patients Obtained CA Score Reduction of at Least 50% in High Dose Group Summary: Genmab’s HuMax-CD4 achieves positive interim results in extended Phase II studies for CTCL Copenhagen, Denmark; February 18, 2004 – Genmab A/S (CSE: GEN) announced today 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.” About HuMax-CD4 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). Disease prevalence 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. 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. Non-cutaneous T-cell lymphomas that are positive for the CD4 receptor are predominantly of the nodal subtype. This includes peripheral and angioimmunoblastic T-cell lymphomas of which 75% are CD4 positive and anaplastic large cell lymphomas of which 20% are. The combined incidence of these lymphomas is approximately 2,770 in the US and Canada and 3,280 in industrialized Europe. Their prevalence in Europe is approximately 10,000 and in US and Canada it ranges from 8,000 to 10,000.