MORRIS PLAINS, N.J.-- Immunomedics, Inc. , a biopharmaceutical company focused on developing therapeutic monoclonal antibodies, today announced that their partner, UCB , has received notification from FDA that the clinical hold on existing trials with epratuzumab in patients with lupus has been lifted.
"We are pleased that the FDA has agreed to remove the clinical hold status of the trials, and we plan to continue to work closely with UCB to make epratuzumab available to patients who were in the suspended trials, and who remain in urgent need," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics.
Protocol amendments will now be submitted to Institutional Review Boards to seek approval to treat patients who remain on the currently suspended studies, and who are in need of re-treatment.
Epratuzumab is a monoclonal antibody that is specific for CD22. CD22 is a designation for a protein on B cells of the immune system. When this antibody binds to [B lymphocyte adhsesion molecule] the B cell cannot be activated, thus halting self antibody production, of which consitutes lupus. FYI, the most common auto antibody in lupus is specific for double stranded DNA.
IMMU closed today's trading on the NASDAQ exchange at 2.46 or up 1 cent per share.
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