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news.Takeda Pharmaceutical have reported Affymax has dosed the first patient in the open-label, randomized controlled, Phase III clinical program of its lead investigational therapy, Hematide, for the treatment of anemia in chronic renal failure patients.
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The program, involving approximately 2,200 chronic renal failure patients, consists of four trials in the US and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis. The primary efficacy endpoint will be the mean change in hemoglobin from baseline. The hemoglobin target range will be 11-12 g/dL for studies in non-dialysis patients, and 10-12 g/dL for studies in dialysis patients. Treatment in each study will be continued until the last patient has been treated for 52 weeks.
Arlene Morris, president and CEO of Affymax, said: “The initiation of our Phase III program for Hematide is a significant milestone for Affymax, which positions us closer to our ultimate goal of providing a convenient monthly treatment alternative to the many patients suffering with anemia. We anticipate all trials in the Phase III renal program will begin enrolling patients by the end of the year with the goal of completing enrollment in each of the trials in 2008. We expect the submission of a new drug application for Hematide in chronic renal failure in 2010 if all goes as planned.”
Mr Yasuchika Hasegawa, president of Takeda, said: “We are very excited with the initiation of the Phase III program for Hematide. Together with Affymax, we are conducting development activities worldwide in both renal and oncology indications, and we are looking forward to bringing this novel treatment option as soon as possible to patients suffering with anemia.”