Data will be presented during Renal Week 2008,November 4th through 9th in Philadelphia, Pennsylvania
MISGAV, Israel and LONDON, Nov. 3 /PRNewswire-FirstCall/ -- Medgenics (AIM: MEDG), is pleased to announce encouraging preliminary data for its Phase I/II clinical trial.
The landmark Phase I/II clinical trial of Medgenics' 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 3-6 months. Each subject will be monitored for 6 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 2 and the other 3 Biopumps, reflecting the respective number needed to provide the intended low daily EPO dose of 18-25 IU/kg/day in each subject. The hemoglobin levels of each of these subjects have risen and remain within the target range of between 10 and 12 grams 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 10-12 grams 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 Directors expect to commence testing on further subjects before the end of 2008.
The Directors are encouraged by the fact that, although the trials are
at an early stage, the elevated hemog
|SOURCE Medgenics, Inc.|
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