среда, 9 апреля 2008 г.

Affymax and takeda report long-term safety and effectiveness data of hematide in chronic renal failure patients with anemia

Data showed that Hematide, dosed once every four weeks, successfully maintained mean hemoglobin levels between 11 and 12 g/dL for up to 18 months in hemodialysis patients who previously were treated with epoetin alfa.Appeared generally well-tolerated.Geronemus, M.Associate professor, Florida Atlantic University and medical director, South Florida Research Institute, is the lead author of the poster which was presented at the National Kidney Foundation 2008 Spring Clinical Meeting."These data are encouraging because they demonstrate the ability of Hematide to maintain mean stable hemoglobin levels in these chronic renal failure study participants, while only dosing once every four weeks," said Dr. ABOUT THE PHASE 2 STUDY 81 dialysis patients, originally enrolled in an open-label study to evaluate a switch from epoetin alfa to Hematide, were rolled over to the long-term Phase 2 trial, and then maintained on Hematide for the duration of the follow-up study.Received intravenous Hematide once every four weeks for approximately 18 months, totaling 18 doses.Was designed to maintain Hb between 10-12.In this analysis at 18 months, the mean hemoglobin value was 11. Generally, Hematide was well-tolerated in this study.Patients or 6.Experienced adverse events assessed as possibly related to Hematide, such as diarrhea, feeling hot, insomnia, oedema peripheral, and pain in extremities.Events were assessed as not related to study drug.ABOUT HEMATIDE Hematide is a novel synthetic, pegylated peptidicpound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).Affymax and Takeda are collaborating on the development of Hematide and plan toercialize the product in the United States.Product, upon approval, will bemercialized in the European Union by Takeda.Is conducting Phase 3 clinical trials for Hematide to treat anemia associated with chronic renal failure and Takeda is focused on the recently initiated Phase 1 clinical trial in the U.To evaluate Hematide to treat chemotherapy-induced anemia in prostate, breast and non-small cell lung cancer patients.ABOUT AFFYMAX, INC.Affymax, Inc.A biopharmaceuticalpany developing novel drugs to improve the treatment of serious and often life-threatening conditions.Additional information, please visit .TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.Based in Deerfield, Ill.London, U.Takeda Global Research & Development Center, Inc.A wholly owned subsidiary of Takeda Pharmaceuticalpany Limited, the largest pharmaceuticalpany in Japan.Research "> HOW INTERESTING WAS THIS ARTICLE?Not Very.
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