Patients with Bone marrow disorder Myelodysplastic Syndrome (MDS), treated with 500 mcg of Aranesp (Darbepoetin alfa) for every three weeks found to improve the hemoglobin content in 70% of patients. The new drug Aranesp is manufactured by Amgen Biotech, which conducted a Phase II trial with 200 low-risk MDS patients who were administered with 500 mcg of Aranesp every three weeks. MDS is a pre-leukemia stage in which the bone marrow does not produce the required blood cells. MDS is associated with abnormal blood counts resulting in anemia (low red blood cell count), Neutropenia (low white blood cell count) and Thrombocytopenia (low blood platelet count).
Professor Janice Gabrilove, Medical Oncologist, Mount Sinai School of Medicine, New York said that, "During the course of their disease, the majority of MDS patients develop clinically significant anemia, which can lead to fatigue and the need for red blood cell transfusions currently, there are no recombinant erythropoietic products approved for the treatment of anemia in MDS patients."
The Phase II trial was conducted for 13 weeks and their erythroid response was evaluated by measuring the hemoglobin, 70 percent of patients had an erythroid response, with 49 percent classified as major response , 67% of patients achieved the target hemoglobin level of 11 g/dL. 19% in the erythropoietin-naive group had at least one transfusion during the 13-week observation period. In the group previously treated with an erythropoietic agent (n= 59), 44 percent experienced an erythroid response, with 24 percent classified as major. Forty-five percent of patients achieved the target hemoglobin level of 11 g/dL, and 29 percent had at least one transfusion.