In a prior Phase I/Phase II study with EPODURE Biopumps, Medgenics treated pre-dialysis patients with chronic kidney disease. That study, which only allowed for a single fixed dose to each patient, showed that a single administration of EPODURE Biopumps successfully raised or maintained hemoglobin in the therapeutic range for six to 36 months without the need for EPO or ESA injections, while serum EPO levels remained within normal range. This latest Phase IIa study allows for an adjustment of the initial dose based on the patient’s response to the prior EPO injections, which the administration of EPODURE Biopumps aims to replace for many months at a time.For the first two patients in the current study, the EPODURE procedure has gone well, as in the previous study, and EPO concentrations were confirmed to be elevated within normal range in the patients’ blood in the days following EPODURE administration. This is consistent with the Phase I/Phase II findings, which indicated that EPODURE Biopumps were delivering EPO in the patients. Moving forward, patients will be followed to determine how long their hemoglobin levels remain in the desired range while EPO levels remain within normal range.
First Subjects Enrolled In Phase IIa Clinical Trial Of EPODURE Biopumps To Treat Anemia In Patients With End-Stage Renal Disease On Dialysis
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