MEDG Medgenics(Regs)

 

TIDMMEDG 
 
RNS Number : 5442P 
Medgenics Inc 
19 July 2010 
 
 
 
 
                                Medgenics, Inc. 
                         ('Medgenics' or the 'Company') 
 
    Medgenics Announces Encouraging New Results in Phase I/II Trials to Treat 
                                    Anaemia 
 
    Higher Dose EPO Biopumps Produce Dose-Dependent Increases in Haemoglobin 
 
Misgav, Israel and London, UK -19 July 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 encouraging new results in the Company's ongoing 
Phase I/II clinical trials with EPODURE to treat anaemia.  As announced on 22 
June 2010, two new patients have joined the Company's Phase I/II clinical trial, 
using Biopumps producing middle dose levels of erythropoietin ('EPO') (40 
IU/kg/day). Now, through 4 weeks following treatment, these patients have shown 
a greater therapeutic response to the higher dose than was obtained in similar 
patients in the low dose group (20 IU/kg/day).  Although individual patient 
response to EPO dose varies, comparing the response in the corresponding 
patients treated with half the dose with the response in these two patients 
receiving the higher dose shows: 
 
 
 
·      1.1-1.2 g/dl elevation of haemoglobin, versus to 0.5-0.75g/dl in the 
low-dose group; and 
 
 
·      substantially greater rise in new red blood cells (reticulocyte count): 
120-200 versus  60 reticulocytes/nl in the comparable patients. 
 
Four weeks post-treatment is a typical period used for evaluating initial 
haemoglobin response to a given EPO dose.  Taken together thus far, these 
findings indicate that the mid-dose patients are having a stronger response than 
seen in the low dose group. 
These results, although only in two patients for their first month of treatment, 
are encouraging early signs of a dose-dependent response - an important 
objective of the current new stage of the trials. 
In the first part of the Company's Phase I/II clinical trial, the focus was on 
the (20 IU/kg/day) dose, equivalent to the lowest recommended dose for EPO, 
administered in 6 of the patients treated, with one patient treated with the 
middle recommended dose (40 IU/kg/day).  The Biopumps produced EPO continuously 
in all the patients, elevating or maintaining the haemoglobin levels in most, 
even with the lowest EPO dose, with most continuing for the 6 month duration of 
the trial and one for more than 20 months. 
 
This second part of the trial is aimed at treating new patients with the medium 
and higher EPODURE doses to confirm that haemoglobin will be safely maintained 
or elevated over the period of the trial using these higher dosage levels of EPO 
delivery, and to show evidence of dose-dependence:  greater administered EPODURE 
dose should generally result in greater haemoglobin response. 
 
Biopumps produced from the two new patients who entered this phase of the study 
were administered to them on 17 June 2010.  Only 3-4 Biopumps were needed in 
each patient to deliver a total of 40 IU/kg/day. As noted, this has now been 
followed at 4 weeks post-treatment by greater haemoglobin response in these 
patients than has been seen in the previous patients.  These results are a 
significant step towards demonstrating sustained dose-dependent haemoglobin 
response, and in the Company's development of EPODURE Biopump. 
 
Dr. Andrew Pearlman, CEO of Medgenics commented: "We are pleased with the strong 
response of these first patients treated in the new part of our study.  We are 
particularly gratified by the greater rise in haemoglobin in these patients 
compared to the lower dose counterparts, a finding that supports our belief that 
EPODURE is a dosable treatment.  We are confident that the coming weeks and 
months will confirm for the mid-dose what we have shown at lower dose:  that a 
single administration of Biopumps can provide many months of effective anaemia 
therapy in these patients replacing scores of EPO injections.  We now look 
forward to following these patients, while recruiting additional patients to the 
trial in the coming months." 
 
 
 
 
For further information, contact: 
 
Andrew Pearlman                                               +972 4 902 8900 
CEO 
Medgenics, Inc 
 
Mike Wort / Anna Dunphy                                   +44 207 861 3838 
De Facto Communications (PR) 
 
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) 
 
 
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 negotiated 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 to produce 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 6-20 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 
 
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