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news.Medgenics has presented positive results from Phase I/II clinical trial of Epodure Biopump to treat anemia in chronic kidney disease patients.
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Epodure, a long-acting protein therapy product, helps deliver erythropoietin for many months from a single administration and has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for six to more than 36 months.
The open-label, dose-ranging study in anemic chronic kidney disease (CKD) patients was intended to show that Epodure can provide over six months of sustained erythropoietin (EPO) delivery from a single treatment using autologous 30mm x 2mm dermis core biopsies.
The trial comprised 13 patients (four EPO-naïve, nine EPO-dependent) treated for 6-30 months with 20 or 40 IU/kg/day Epodure implanted dose.
The data demonstrated that the drug delivery system was well tolerated and there were no anti-EPO antibody formations and no serum EPO levels to date above 60 mU/ml.
In addition, Epodure treatment maintained hemoglobin between 10-12 g/dl in 10/13 patients for more than three months and 6/13 patients for more than six months.
Medgenics president and CEO Andrew Pearlman said the positive data would drive them to advance the clinical development of Epodure to treat anemia.
"A safe, sustained delivery of EPO could reduce the risks of hemoglobin variability while achieving the recommended hemoglobin targets, thereby avoiding the supraphysiologic EPO concentrations associated with the current injections of ESAs," Pearlman added.