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news.Antibody-based products developer Immunomedics has received notice from the FDA granting epratuzumab fast track product designation for the treatment of systemic lupus erythematosus, a chronic inflammatory autoimmune disorder.
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Epratuzumab is a versatile humanized monoclonal antibody targeting B-cell-mediated autoimmune diseases and non-Hodgkin’s Lymphoma. According to Cynthia Sullivan, president and CEO of Immunomedics, the company’s clinical plans for epratuzumab include the initiation of phase III trials in the first half of 2005.
“We believe that epratuzumab has therapeutic potential in lowering disease activities in various organs, as demonstrated by our recent phase II studies in Europe,” commented Dr Ivan Horak, executive vice president of R&D, and chief scientific officer at Immunomedics.
“Epratuzumab seems to show activity in systemic lupus erythematosus (SLE) patients without a drastic drop in their circulating B- lymphocytes, thus perhaps reducing their risk of infection. This suggests to us that this CD22-targeting molecule may work by modulating B-cell function, as contrasted by other B-cell antibodies that appear to require depletion of B-cells,” Dr Horak further explained.