OUtline of Clinical Studies Granulocyte Colony ( KRN 8601 ) on Recombinant Human Stimulating Factor in Japan

tration. Safety and tolerance to KRN 860l were confirrned and a dose-related increase of neutrophil counts by KRN 8601 was observed. In an early phase II study, the safety and tolerance to KRN 8601 in cases of neutropenia following canceT chemotherapy were shown at doses of 25-800 "glm2 and an improvement of neutropenia was seen at doses of more than 50 "g/m2. . In a phase II study, the optimal dose was investigated for subcutaneous administration and intravenous drip infusion in cases of neutropenia induced by chemotherapy for malignant lymph" mas. Thc optimal dose was 75"g/body (about 50"g/m2) for subcutaneous administration and 100-200 pag/m2 for intravenous drip infusion, In a phase III study. a double-blind prospective randoTnized trial comparing KRN 8601 with an inactive placebo against malignant 1ymphomas was performed and the inhibitory, improvement and