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Published on 6/5/2006 in the Prospect News Biotech Daily.

Amgen says interim data points to benefit of Aranesp for chemotherapy-induced anemia

New York, June 5 - Amgen Inc. announced interim phase 3 data suggesting Aranesp (darbepoetin alfa) administered every three weeks with intravenous iron has the potential to further enhance the effectiveness of increasing patient hemoglobin levels to the recommended target of greater than or equal to 11 g/dL and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia.

The data was presented at the annual meeting of the American Society of Clinical Oncology in Atlanta.

"Every-three-week dosing of Aranesp has demonstrated effectiveness in managing chemotherapy-induced anemia and allows physicians to synchronize anemia treatment and chemotherapy, offering improved patient convenience," study investigator Johan Vansteenkiste of the respiratory oncology unit at University Hospital Gasthuisberg, said in a news release.

"The results of this study suggest that Aranesp administered every three weeks in combination with intravenous iron may help maximize the proportion of patients reaching target hemoglobin levels."

Interim results from 196 patients in this phase 3b study demonstrated that, among the 100 patients receiving 500 mcg Aranesp administered every three weeks in combination with intravenous iron, 94% achieved the target hemoglobin level of greater than or equal to 11 g/dL between week five and the end of treatment.

In the 96-patient group tha received Aranesp and iron administered according to standard practice (oral iron or no iron), 89% of patients achieved the target hemoglobin level. Fewer patients in the group administered IV iron received a red blood cell transfusion between week five and the end of treatment compared to patients in the group receiving standard iron administration (12% versus 25%).

The safety profile for patients receiving Aranesp administered with intravenous iron appeared to be comparable to patients receiving Aranesp administered with either oral iron or no iron.

Amgen discovers human therapeutics and is based in Thousand Oaks, Calif.


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