MEDG Medgenics(Regs)

    RNS Number : 2429H
  Medgenics Inc
  03 November 2008
   
    Medgenics, Inc.
    ('Medgenics' or the 'Company')
    MEDGENICS ANNOUNCES ENCOURAGING PRELIMINARY DATA FOR PHASE I/II CLINICAL TRIAL OF EPODURE IN RENAL ANEMIA
    Data will be presented during Renal Week 2008, November 4th through 9th in Philadelphia, Pennsylvania
    Misgav, Israel and London, UK - 3 November, 2008 - 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 hemoglobin levels seen in the 2
subjects currently participating in the trial suggest that immunogenicity issues have not been encountered thus far. Immunogenicity is the
triggering of a natural immune response by the human body which could halt the protein production of the Biopump and which is thought to
have curtailed the duration of EPO delivery in the Company's previous Phase I Clinical Trials, in 2003. In the previous trial, elevated
hemoglobin levels were not seen despite dosage levels at least three times higher than those used thus far in the current trial. The
Directors believe that the elevated hemoglobin levels and the apparent immune acceptance of the implanted EPODURE Biopumps, should be viewed
positively, although more definitive conclusions can only be drawn once more subjects have been tested for a longer period.
    Medgenics' Biopump is a unique tissue-based platform technology that processes a toothpick sized sliver of the inner layer of the
subject's skin and is designed to provide sustained-action protein therapy for the treatment of a range of chronic diseases. As stated in
the Company's Admission Document London AIM Exchange, the Directors believes that the Biopump platform technology will provide a wide range
of advantages over existing protein therapies that will appeal and offer benefits to doctors, patients and third party payers (e.g. medical
insurers). These advantages include:  
    *     Increased efficacy
    *     Improved safety
    *     Reversible treatment
    *     Reduced side effects
    *     Lower costs
    *     Elimination of frequent injections
    *     Extended treatment to undertreated populations
    Additional subjects are being actively recruited for this study taking place at Hadassah Hebrew University Hospital in Jerusalem,
Israel, which aims to test the technology on up to 30 subjects by the end of 2009. 
    These initial results will be presented at Renal Week 2008, the American Society of Nephrologists annual meeting and scientific
exposition, in Philadelphia, Pennsylvania, USA on November 4-9, 2008. Dr. Michal Dranitzki Elhalel, principal nephrologist in the study will
present on Thursday, November 6, 2008 at 4:45 p.m. at the Clinical Nephrology Conference and Medgenics Senior Scientists will present
Medgenics' GMP vector and Toxicity Study in the Poster Session on Saturday, November 8, beginning at 10:00 am, at the Pennsylvania
Convention Center. 
    Commenting on the preliminary results, Dr. Andrew Pearlman, Chief Executive Officer of Medgenics, said:
    "While early data from the first two subjects is only a first indicator from this 30 subject study, we are encouraged that this study
will show that Medgenics' EPODURE Biopump can be used to safely elevate hemoglobin levels in subjects with chronic kidney disease for three
to six months (or more) from a single implant of one or more Biopumps.  We look forward to reporting further as the study proceeds but,
given the data collected and the apparent lack of an adverse immune response to the technology so far, we are cautiously optimistic that the
trial will support the Directors' belief in this breakthrough platform technology."
    For further information, contact: 
 Medgenics, Inc.                                        Phone: +972 4 902 8900
 Dr. Andrew L. Pearlman                                                       
  
 Grayling Global (Financial PR, UK)                    Phone: +44 207 255 5406
 Jonathan Shillington                    jonathan.shillington@uk.grayling.com 
 Alistair Scott
  
 Blomfield Corporate Finance Limited                   Phone: +44 207 489 4500
 (Nominated Adviser)                                                          
 James Pinner
 Alan MacKenzie
  
 SVS Securities plc (Broker)                           Phone: +44 207 638 5600
 Peter Manfield                                                               
 Ian Callaway
  
 United States contacts:                                                      
                                                                              
 Grayling Global, Investor Relations                    Phone: +1 646 284 8472
 Leslie Wolf-Creutzfeldt                          lwolf-creutzfeldt@hfgcg.com 
                                                                              
 Grayling Global, Media Relations                       Phone: +1 646 284 9455
 Ivette Almeida                                            ialmeida@hfgcg.com 
                                                                              
    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 anemic subjects. The Company commenced a Phase I/II clinical trial for its long-acting version of EPODURE, designed to produce
and deliver a therapeutic dose of EPO steadily for three to six months or more, in August 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.

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