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news.Medgenics, a clinical-stage biopharmaceutical company, has announced encouraging preliminary data from its Phase I/II renal anemia clinical trial.
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The Phase I/II clinical trial of Medgenics’s Epodure biopump, for providing sustained treatment of anemia in subjects with chronic kidney disease, is underway. The current trial is designed to assess the safety and efficacy of the Epodure biopump in providing sustained elevation of hemoglobin by delivering sufficient supplemental amounts of the protein erythropoietin (EPO) for three to six months. Each subject will be monitored for six months after the Epodure implantation. Further applications of the biopump platform technology will be developed and tested from 2009 onwards.
The first month’s data from the on-going Phase I/II trial has now been collected from the initial two anemic, chronic kidney disease subjects receiving the lowest dose in this dose escalating study. One subject received two and the other three biopumps, reflecting the respective number needed to provide the intended low daily EPO dose of 18-25 IU/kg/day in each subject.
According to the company, the hemoglobin levels of each of these subjects have risen and remain within the target range of between 10 and 12gms per deciliter for a month, with no adverse effects reported or observed, other than minor localized bruising typically associated with skin biopsy and implant.
The 10-12gms per decilitre range is what is recommended for such patients to treat their anemia. As the trial progresses these subjects will continue to be monitored, additional subjects will be enrolled and further data will be reported as key milestones are achieved, the company said. The directors expect to commence testing on further subjects before the end of 2008.
Additional subjects are being actively recruited for this study taking place at Hadassah Hebrew University Hospital in Jerusalem, Israel, which aims to test the technology on up to 30 subjects by the end of 2009.
Andrew Pearlman, CEO of Medgenics, said: “While early data from the first two subjects is only a first indicator from this 30 subject study, we are encouraged that this study will show that Medgenics’s Epodure biopump can be used to safely elevate hemoglobin levels in subjects with chronic kidney disease for three to six months (or more) from a single implant of one or more biopumps.”