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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

-- EPODURE Biopump demonstrates safety and efficacy for four months with

single administration

-- Institutional Review Board confirms safety and efficacy of low dose and

approves continuation of trial with higher doses

-- Biopump may offer alternative to months of expensive injections

MISGAV, Israel and LONDON, Feb. 3 /PRNewswire/ -- Medgenics (AIM: MEDU/MEDG), today announced that the EPODURE Biopump, the Company's unique tissue-based technology, has successfully demonstrated safety and efficacy for the sustained protein therapy of anemia in patients with chronic kidney disease (CKD).

In the Company's ongoing Phase I/II clinical trial, a one-time administration of EPODURE, producing and delivering the low dose of 18-25 IU/kg/day of the protein erythropoietin (EPO), was sufficient to sustain therapeutic elevation of hemoglobin in most patients. The earliest patients to receive treatment have shown sustained hemoglobin within the target range for four months without receiving any EPO injections. By contrast, in standard practice today, EPO injections are required up to several times per week, and the comparable low dose does not result in sufficient hemoglobin levels in most patients.

By having maintained hemoglobin levels in the target range for several months in more than one patient, the study has already demonstrated that when administered at an appropriate dose for the patient, EPODURE can provide sustained anemia treatment for at least four months while alleviating the need for frequent EPO injections.

The Phase I/II clinical trial was approved for three escalating dose groups, beginning with six patients at the lowest dose, and called for a safety review after treatment of these first six patients prior to treatment using higher doses. The Institutional Review Board (IRB) of Hadassah Hebrew University Hospital in
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SOURCE Medgenics
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