MEDG Medgenics(Regs)

 

TIDMMEDG 
 
RNS Number : 3372V 
Medgenics Inc 
01 November 2010 
 

 
 
 
                                Medgenics, Inc. 
                         ('Medgenics' or the 'Company') 
 
 Patient reaches 2 years Anaemia Relief from Single Treatment in Clinical Trial 
 
Results to be presented at the American Society of Nephrology Annual Convention 
                                on  Nov 19, 2010 
 
    New Biopumps now producing clotting Factor VIII protein for Haemophilia 
                                    treatment 
 
 
Misgav, Israel and London, UK - November 1, 2010 - Medgenics, Inc. (AIM: MEDG, 
MEDU), the company that has developed a novel technology for the manufacture and 
delivery of therapeutic proteins continuously in patients using their own 
tissue, is pleased to announce further positive progress in the Company's 
ongoing Phase I/II clinical trial with EPODURE to treat anaemia, including the 
treatment of additional patients with the middle dose range of continuously 
produced erythropoietin ('EPO'). In addition, the Company announces that it has 
succeeded in creating Biopumps producing Factor VIII in vitro. The Company views 
this as further demonstration of the Biopump platform for producing a range of 
therapeutic proteins. 
 
The Company is pleased to report the following updates on the clinical trial, 
platform development, and commercial partnering: 
 
EPODURE Anaemia Clinical Trial 
 
 
·      12 patients have now received their implanted EPODURE Biopumps in the 
Company's Phase I/II clinical trial, with 5 receiving the dose level of (40 
IU/kg/day), and 7 receiving the lower dose (20 IU/kg/day). 
·      One patient has been successfully treated for anaemia for a full 2 years 
following his single low dose treatment with EPODURE Biopumps in 2008. His 
haemoglobin levels have remained continuously within the target range of 10-12 
g/dl throughout this period without any adverse events and without receiving any 
EPO injections, whereas he was receiving frequent EPO injections before his 
EPODURE treatment.  (EPO injections are the current standard of care for anaemia 
and are produced by recombinant DNA in  rodent cell culture.) 
·      Another patient, whose haemoglobin level had responded positively to the 
low dose of EPODURE, but only reached the low end of the target range of 10-12 
g/dl, has just become the first patient to receive an additional administration 
of low dose EPODURE Biopumps to increase haemoglobin level.  This parallels 
intended clinical use whereby, if there is insufficient haemoglobin response to 
an initial dose of Biopumps, additional Biopumps would be administered to 
further increase the haemoglobin level to reach the desired range.  All previous 
patients have received only a single administration of a fixed dose, without 
possibility of subsequent increase.  The Company views as a significant advance 
the approval for and administration of a second dose of Biopumps in a patient, 
and will be closely monitoring to see if this assists further haemoglobin 
elevation. 
·      The latest results of the clinical trial are to be presented at the 
annual convention of the American Society of Nephrology, one of the largest 
meetings of nephrologists in the world, on November 19th.  The presentation will 
be given by, Prof. Anatole Besarab, of Ford Hospital, Detroit MI - a member of 
the Company's Strategic Advisory Board and a leading authority in renal anaemia. 
Factor VIII ("FVIII") Biopump for Haemophilia 
Medgenics is also pleased to announce that Biopumps are now successfully 
producing active clotting factor VIII protein:  considered by many to be the 
most challenging of proteins to produce in vitro.  The Company views this as a 
further confirmation of the Biopump Platform, with Factor VIII now joining EPO 
and Interferon alpha as proteins continuously produced by Biopumps.  The Company 
is continuing development of its FVIII Biopump to further increase FVIII output 
per Biopump to bring it to target levels thought sufficient to improve blood 
clotting if they were administered to patients with haemophilia.  If successful, 
this would provide a unique and exciting new therapeutic option for haemophilic 
patients which could make a major difference in their lives. 
 
Medgenics is in advanced discussions with its pharmaceutical partner regarding 
continuation of collaboration in development of Factor VIII Biopumps for the 
treatment of haemophilia and will update the market as this moves forward. 
 
Dr. Andrew Pearlman, CEO of Medgenics commented: "We are very pleased that one 
of our patients has now passed his second anniversary free of EPO injections and 
with his haemoglobin right in the target range, and all from a single treatment 
with EPODURE in October 2008.  We are further pleased that we have now treated 
12 patients, including 5 who have received the mid-dose level, and look forward 
to following their response in the coming months.  We are further excited about 
the presentation of our study by Prof Besarab at the upcoming major nephrology 
conference.  Last but not least, we are proud to announce that we have shown we 
can make Biopumps producing clotting factor VIII for haemophilia, and look 
forward to further improvements in output with continued collaboration with our 
pharmaceutical partner." 
 
Dr. Eugene Bauer, Chairman of Medgenics commented:  "Progress continues on 
Medgenics' EPODURE program.  We are especially pleased that one patient has now 
been treated for two years without additional intervention.  Further, our 
development program for haemophilia A has progressed to the point of 
reproducible in vitro expression of active Factor VIII by our proprietary tissue 
Biopumps, and we are hopeful that our continued development will advance the 
performance to meet levels we need to give us confidence to move to a clinical 
level program." 
 
 
 
 
 
 
For further information, contact: 
 
Andrew Pearlman                                               +972 4 902 8900 
CEO 
Medgenics, Inc 
 
Mike Wort / Anna Dunphy                                   +44 207 861 3838 
De Facto Communications (IR) 
 
James Pinner / Derek Crowhurst                          +44 207 444 0800 
Religare Capital Markets (Nomad) 
 
 
Ian Callaway / Alex Mattey                                 +44 207 638 5600 
SVS Securities plc (Joint Broker) 
 
Jonathan Senior                                                 +44 207 776 1219 
Nomura Code (Joint Broker) 
 
Leslie Wolf-Creutzfeldt                                        +1 646 284 9472 
Grayling (Investment Relations - US) 
 
Notes to Editors: 
Medgenics is a commercial-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. The first revenue 
generating commercial deal with a well known multinational pharmaceutical 
company was concluded in late 2009. 
Biopumps are made using 30 mm long tissue samples taken by needle biopsies from 
the lower layer of the patient's skin under local anaesthetic, and processed 
during 10-14 days to become "biofactories" producing the required protein.  The 
requisite number of Biopumps are injected under the patient's skin to provide 
sustained protein production and delivery for many months. Dose can be reduced 
by ablating one or more Biopumps, or increased by injecting additional units. 
The Company is developing the Biopump to provide substantially greater safety 
and reliability in protein treatment in a more cost effective manner than 
offered by the existing injected protein therapies or current alternatives. 
Medgenics currently has three products in development based on this technology, 
addressing the indications of: 
 
 - Anaemia - using EPODURE, a Biopump 
producing erythropoietin (EPO) 
- Hepatitis-C - using INFRADURE, a Biopump producing interferon-alpha (IFN-a) 
- Haemophilia - using a Biopump producing clotting Factor VIII 
The Company's Phase I/II clinical trial using EPODURE to treat anaemia in 
patients with chronic kidney disease has demonstrated proof of concept of the 
Biopump. Designed to produce and deliver a therapeutic dose of EPO steadily for 
six months or more, EPODURE Biopumps have already provided effective anaemia 
treatment in most of the longest participating patients for 6-24 months, even at 
the low administered dose. 
Medgenics intends to develop its innovative products and bring them to market 
via multiple strategic partnerships with major pharmaceutical and/or medical 
device companies. In addition to treatments for anaemia, hepatitis-C and 
haemophilia, 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 $95 billion by the end of 2010. Other 
potential applications of Biopumps producing various proteins include multiple 
sclerosis, arthritis, paediatric growth hormone deficiency, obesity, and 
diabetes. 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
 MSCLIFVELALLIII 
 

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