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news.Medgenics has received approval from the Israel's Ministry of Health to start its landmark Phase I/II safety and efficacy trial of its Epodure Biopump for providing sustained treatment of anemia in patients with chronic kidney disease.
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Patient recruitment has now commenced for the trial, with the first patients expected to receive their Biopumps within six weeks. The trial is taking place at the Hadassah University Medical Center in Jerusalem, Israel and will aim to treat up to 30 patients.
This study aims to assess the safety and efficacy of Epodure at increasing, controlled dose ranges, in providing sustained, elevated levels of the deficient protein erythropoietin (EPO) and, thereby, in elevating the red blood cell count and hemoglobin levels for up to four-six months in those patients receiving appropriate doses.
The first patients are scheduled to receive the lowest dose range of up to 20 units of EPO per kilogram per day. Once an interim review has confirmed initial safety in at least six patients, higher doses of 40 and 60 units are planned.
Andrew Pearlman, CEO of Medgenics, said: “This key approval moves Medgenics closer to proving the proprietary platform technology to enable patients to produce their own natural human protein therapy for treatment of a range of chronic diseases, and should strengthen Medgenics’s position for strategic partnering.”