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Medgenics Announces Positive Data From Phase I/II Clinical Trial of EPODURE Treatment of Anemia in Chronic Kidney Disease
Date:2/3/2009

Jerusalem, Israel, where the study is being conducted, has now reviewed the results for this first group of patients and has confirmed the safety and efficacy of EPODURE at the low dose and approved the continued recruitment and treatment of patients in the trial using higher EPODURE doses,

Even with the low dose, the hemoglobin levels of most of the patients have remained within 10-12 grams per deciliter, the target range indicated by FDA guidelines for CKD patients, with no adverse effects reported or observed. Five of the six patients have now had EPODURE for more than one month, with target range having been maintained for four months in two of them, and for more than a month thus far in another. The results from the patients to date indicate that EPODURE is safe and well tolerated and suggests that it can provide effective treatment of chronic anemia.

Commenting on the results, Dr. Andrew Pearlman, Chief Executive Officer of Medgenics, said,

"This is a very exciting and important milestone for the Company, particularly because we have shown such a clear effect in most patients, even in the lowest dose group of our trial. The fact that hemoglobin levels continue to show sustained elevation in most of these patients indicates the immune acceptance of the implanted EPODURE Biopumps, and suggests that in the right dose for a given patient, we can indeed treat anemia effectively for at least four months with a single EPODURE treatment without the need for additional EPO injections. This strongly supports the Directors' belief that the EPODURE Biopump can be an effective long-term treatment for anemia. We look forward to seeing EPODURE's performance in the next group of patients who will be receiving higher doses."

Professor Eugene Bauer, MD, Dean Emeritus, Stanford University School of Medicine and Chairman of Medgenics commented:

"This is a groundbreaking study.
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SOURCE Medgenics
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