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To: Icebrg who wrote (833)	6/26/2004 4:41:03 AM
From: Icebrg	Respond to of 2240

Genmab: diagnostic testing kits could increase uptake of new CLL treatment The FDA has accepted Genmab's Investigational New Drug application for HuMax-CD20. June 21, 2004 5:29 PM GMT (Datamonitor) - HuMax-CD20, developed by Genmab [GEN.CO] to treat relapsed or refractory chronic lymphocytic leukemia, has had its Investigational New Drug (IND) application accepted by the FDA. Genmab should consider also developing a diagnostic testing kit to categorize patients by which B-cell antigens are present, thus increasing uptake of the new treatment. HuMax-CD20 is a human antibody targeted at the CD20 antigen, a transmembrane protein on pre-B and mature B-lymphocytes. CD20 is found on over 90% of B-cell lymphomas. HuMax-CD20 binds to a unique site on CD20 target cells and is released very slowly over time. Preclinical studies have shown HuMax-CD20 to induce complement-mediated cytotoxicity of B-cell tumors in patients resistant to rituximab, a drug marketed as Genentech [DNA]/Roche's [ROCZ.S] Rituxan. In addition, HuMax-CD20 was found to deplete B-cells for four times longer than Rituxan. The Phase I/II clinical trial investigating HuMax-CD20, due to be initiated this summer, will treat 32 patients for four weeks. Patients will initially receive a dose of 100mg, 300mg or 500mg of the drug, followed by three weekly doses of 500mg, 1000mg or 2000mg, respectively. The primary endpoint of the trial is objective tumor response. In addition, efficacy information will be gleaned by expanding the highest dose group to 26 patients. Chronic lymphocytic leukemia (CLL) is a subgroup of non-Hodgkin's lymphoma (NHL), and is the most common type of leukemia in adults in the US and most of western Europe. In the US, between 8,000 and 12,500 new cases are diagnosed per year. Between 85-95% of all CLL cases are of B-cell origin, indicating that HuMax-CD20 has major potential for the treatment of the disease. Millennium Pharmaceutical's [MLNM] Campath (alemtuzumab) is currently the only approved treatment for refractory CLL. If HuMax-CD20 is granted approval, albeit after several more years of clinical trials, Campath will inevitably face competition. However, while HuMax-CD20 targets the CD20 antigen, Campath targets the CD52 antigen. If Genmab were to develop a diagnostic testing kit to categorize CLL patients into subgroups, depending on which B-cell antigens are present, the uptake of HuMax-CD20 would be increased, and patients would be given the highest chance of a tumor response. commentwire.com