fibrinoplate Lypholized Formulation

Fibrinoplate is a second generation product which has been freeze-dried for long-term storage. Immediately before administration to a patient, it will be converted to a suspension by the addition of sterile distilled water.

Fibrinoplate is a polymerized human albumin microsphere coated with human fibrinogen. The activity of Fibrinoplate is measured by the amount of fibrinogen peptide A (FPA) released from the microspheres. The preclinical studies used severely thrombocytopenic rabbits. The intravenous administration of Fibrinoplate at 3ml/kg, 6ml/kg and 9ml/kg respectively, significantly reduced their bleeding time and bleeding blood amount.

The phase II and phase III clinical trial is each sub-divided into double blind control manner and open trial. The enrollment patients was 102, 223 and 63, 214, respectively. The diagnosis of the patients included refractory idiopathic thrombocytopenic purpura (ITP), acute leukemia, acute aplastic anemia and myelodysplastic syndrome. The patient’s platelet count is < 30X109/L. The placebo is human albumin microsphere. Each patient received intravenous administration 7.0mg/kg of Fibrinoplate or placebo respectively.

The results showed that the bleeding time difference of 0 hour vs 2 hour in Fibrinoplate group is 670.3±564.5, control group is –55.5±199.1 (p=0.000) and 0 hour vs 25 hour in Fibrinoplate groups is 459.2±577.0, control group is –8.8±372.9 (p=0.042). In the open clinical trial the results showed that the bleeding time difference of 0 hour vs 2 hour is 480.6±51 (p=0.000).