Amgen reports interim phase 2 data shows Aranesp helps patients with myelodysplastic syndrome

New York, Dec. 12 - Amgen, Inc. said interim data from a phase 2 study evaluating Aranesp (darbepoetin alfa) to treat anemia in patients with a bone marrow disorder known as myelodysplastic syndrome showed positive results.

"During the course of their disease, the majority of MDS [myelodysplastic syndrome] patients develop clinically significant anemia, which can lead to fatigue and the need for red blood cell transfusions," said Janice Gabrilove, professor of medicine, hematology and medical oncology at Mount Sinai School of Medicine, New York and the study's lead investigator.

"Currently, there are no recombinant erythropoietic products approved for the treatment of anemia in MDS patients. These results are encouraging."

Patients received 500 mcg of Aranesp every three weeks.

Low-risk myelodysplastic syndrome patients, who had no prior erythropoietic therapy, exhibited an overall response of 70%, increased hemoglobin levels and improvements in patient-reported fatigue, according to data presented at the American Society of Hematology's 47th annual meeting in Atlanta.

Results for the 13-week test period were presented for 189 of 209 patients enrolled.

In the group that had no previous treatment with an erythropoietic agent, 70 percent of patients had an erythroid response, with 49% classified as major response (defined as greater than or equal to 2 grams per deciliter (g/dL) increase from baseline hemoglobin or transfusion independence). Sixty-seven percent of patients achieved the target hemoglobin level of 11 g/dL. Nineteen percent in the erythropoietin-naive group had at least one transfusion during the 13-week observation period.

In the 59-member group previously treated with an erythropoietic agent, 44% experienced an erythroid response, with 24% classified as major. Forty-five percent of patients achieved the target hemoglobin level of 11 g/dL, and 29% had at least one transfusion.

During the 13-week test period, 78% of patients experienced at least one adverse event. Seventeen percent experienced a serious adverse event, with fatigue, asthenia and diarrhea as the most common. Six percent had treatment-related adverse events, with injection-site pain and diarrhea the most common. No thrombotic events have been reported to date in this study.

Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of red blood cells).

Amgen is a Thousand Oaks, Calif.-based biotechnology company.

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