Biotest AG announced that the first patient has been treated in study no. 992 a phase III study investigating IgG Next Generation as immunomodulatory therapy in patients diagnosed with chronic primary immune thrombocytopenia, an autoimmune disease in which the immune system attacks and destroys the body's own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting. The study is planned to include approximately 40 patients and will be conducted in a total of 18 study sites in Germany, Hungary, Spain, Bulgaria, Czech Republic and Serbia. According to the European Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG), there are two key studies required for the licensing of an IVIG in the European markets. Clinical data on efficacy and safety have to be generated in PID and primary immune thrombocytopenia (ITP) to provide evidence as replacement therapy and to prove the immunomodulatory effect of immunoglobulines, respectively. IgG Next Generation is manufactured using a brand new production process and will serve as the master product or the new Biotest Next Level manufacturing facility currently under construction. This new manufacturing facility, represents Biotest's latest commitment to the global immunoglobulin markets. Study no. 992 is a phase III, open label, prospective, multicenter trial investigating the clinical efficacy and safety of IgG Next Generation as immunomodulatory therapy in adult patients diagnosed with chronic primary immune thrombocytopenia (ITP) at high risk of bleeding or before surgery to correct the platelet count. Subjects will be randomized in a 1:1 ratio to receive either 1 g/kg bodyweight per day for 2 consecutive days or 0.4 g/kg bodyweight per day on 5 consecutive days. The primary objective of this study is to determine the percentage of patients who achieve response. Primary immune thrombocytopenia also formerly known as idiopathic thrombocytopenic purpura or Immune thrombocytopenic purpura is an autoimmune-mediated condition, in which autoantibodies with specificity for one or more platelet membrane glycoproteins (GPs), binds to circulating platelet membranes. The coating of platelets with autoantibodies renders them susceptible for elimination from the blood.Because patients suffering from ITP have a low platelet count, they may bruise easily and experience bleeding that is hard to stop. ITP is a rare blood disorder that affects about five to nine in 100,000 adults each year.