RNS Number : 1948A
  Medgenics Inc
  30 July 2008
   

    Medgenics, Inc.
    ('Medgenics' or the 'Company')

    MEDGENICS GRANTED APPROVAL TO COMMENCE ITS LANDMARK PHASE I/II CLINICAL STUDY OF EPODURE TO TREAT ANAEMIA 

    Misgav, Israel and London, UK - 30 July, 2008 - 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."

    ����

    For further information, contact:

 Medgenics, Inc.                                        Phone: +972 4 902 8900
 Dr. Andrew L. Pearlman 
 Citigate Dewe Rogerson                                Phone: +44 207 638 9571
 Dr. Mark Swallow
 Jonathan Shillington (Global Consulting Group)
  
 Blomfield Corporate Finance Limited                   Phone: +44 207 489 4500
 James Pinner
 Alan MacKenzie
  
 SVS Securities plc (Broker)                           Phone: +44 207 638 5600
 Peter Manfield
 Ian Callaway

    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 

    CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
    This release contains forward-looking statements, which include all statements other than statements of historical fact, including
(without limitation) those regarding the Company's financial position, business strategy, plans and objectives of management for future
operations. These statements relate to future events, prospects, developments and strategies. Forward-looking statements are sometimes
identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning,
"expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable
terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of
these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially
from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly
disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to
reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such
statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not
occur.

This information is provided by RNS
The company news service from the London Stock Exchange
 
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