Medgenics Granted Approval to Commence Its Landmark Phase I/II Clinical Study of EPODURE to Treat Anaemia

  
    
  
  
    
      Medgenics (AIM:MEDG) announces that it has received approval from Israel’s 
      Ministry of Health (MOH) to commence its landmark Phase I/II safety and 
      efficacy trial of its EPODURE Biopump for providing sustained treatment 
      of anaemia in patients with chronic kidney disease. 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 4–6 
      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 6 patients, higher doses of 40 and 60 Units are 
      planned.
    
    
      Commenting on the approval Dr. Andrew Pearlman, Chief Executive Officer 
      of Medgenics, said:
    
    
      “This is clearly the most important milestone 
      for Medgenics since its admission to AIM, as our primary focus this past 
      year has been to prepare for this key clinical trial. This study aims to 
      demonstrate not only the basic safety and efficacy of EPODURE for 
      treating anaemic patients but, more broadly, to prove the concept of our 
      Biopump platform technology as an innovative approach for treating 
      chronic diseases. We are very pleased to have received this important 
      approval from the MOH and look forward to recruiting the first patients 
      and to reporting initial results within 3–5 
      months after they receive their own EPODURE implants. 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’ 
      position for strategic partnering.”
    
    
      NOTES TO EDITORS:
    
    
      Medgenics, Inc. is a clinical-stage biopharmaceutical company developing 
      its unique tissue-based Biopump platform technology to provide 
      sustained-action protein therapy for the treatment of a range of chronic 
      diseases.
    
    
      Medgenics currently has two products in development based on this 
      technology:
    
    
      
        EPODURE – producing erythropoietin (EPO) to 
        treat anaemia
      
      
        INFRADURE – producing interferon-alpha (IFN-?) 
        to treat hepatitis C
      
    
    
      The Company has demonstrated proof of principle of the Biopump treatment 
      procedure in a clinical trial using a short-acting version of EPODURE in 
      anaemic patients. A long-acting version of EPODURE, designed to produce 
      and deliver a therapeutic dose of EPO steadily for six months or more, 
      entered a Phase I/II trial in mid-2008. The Company plans to follow with 
      a clinical trial of INFRADURE in 2009.
    
    
      Medgenics intends to develop its innovative products and bring them to 
      market via multiple strategic partnerships with major pharmaceutical 
      and/or medical device companies, starting with EPODURE and INFRADURE.
    
    
      Beyond these, Medgenics plans to develop and/or out-license a pipeline 
      of future Biopump products targeting the large and rapidly growing 
      global protein therapy market, which is forecast to reach US $87 billion 
      by 2010. Other potential areas include multiple sclerosis (interferon-?), 
      haemophilia (Factor XIII), paediatric growth hormone deficiency (human 
      growth hormone) and diabetes (insulin).
    
    
      Founded in 2000, Medgenics is a US-incorporated company with major 
      operations in Misgav, Israel. Medgenics was admitted to AIM in December 
      2007 (AIM:MEDG).
    
    
      www.medgenics.com
    
    
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