MEDG Medgenics(Regs)

 

TIDMMEDG 
 
RNS Number : 9877N 
Medgenics Inc 
22 June 2010 
 
 
 
 
                                Medgenics, Inc. 
                         ('Medgenics' or the 'Company') 
 
 
                  Higher Dose EPO Biopumps Working in Patients 
 
Misgav, Israel and London, UK -22 June 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 that the first new patients have now successfully 
commenced their treatment using biopumps producing middle dose levels of EPO in 
the Company's ongoing Phase I/II clinical trials with EPODURE. The new patients 
were also the first to have their Biopumps prepared at a remote site (the GMP 
processing center in Jerusalem), transported in a sealed chamber and 
subsequently administered locally at a major teaching hospital in Tel Aviv - 
thus successfully demonstrating the concept of a regional Biopump processing 
center serving a local treatment center, which is important for the wider 
implementation planned in the future. 
 
In the first part of the Company's Phase I/II clinical trial, completed in 2009 
at the Hadassah Medical Center in Jerusalem, the equivalent of the lowest 
recommended dose for EPO (20 IU/kg/day) was prepared at the local GMP center and 
administered in 6 of the patients treated and one patient was 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 many, 
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 being conducted at the Tel Aviv Medical Center, 
and  is aimed at treating new patients with the medium and higher continuous 
doses to confirm that haemoglobin will be maintained or elevated over the period 
of the trial at higher dosage levels of EPO delivery.  Demonstrating elevation 
of the haemoglobin level and its maintenance within the normal therapeutic range 
are primary objectives of this trial. 
 
In this new stage of the continuing Phase I/II clinical trial, sufficient 
EPODURE biopumps will be administered to each patient to provide 40 IU/kg/day. 
Two weeks ago, the team conducting the trial at Tel Aviv Medical Center 
successfully harvested micro-organs from the first two new patients entering the 
study and processed them to become EPODURE biopumps.  These biopumps produced 
sufficient EPO per day that only 3 or 4 biopumps were necessary in each patient, 
and these were administered to them on June 17. 
 
The treatment of these new patients is possible as a result of the recently 
announced, successful fundraising rounds. The Company is now delivering on its 
plan to move forward with these trials, which have already demonstrated safety 
and proof of concept of the EPODURE biopump, and now aim to show a trend of 
greater haemoglobin responses with the higher doses administered. Following the 
implantation, the EPO measurements from the post-implant blood samples have 
confirmed a significant rise in serum EPO levels, demonstrating that the 
biopumps are efficiently delivering the protein in these patients.  In the 
previous part of this trial, confirmed EPO production in situ was followed by an 
elevation of haemoglobin levels within the ensuing months and the Company is 
confident that this will also happen in this higher dose stage of the trial. 
 
Dr. Andrew Pearlman, CEO of Medgenics commented: "We are very pleased that the 
first patients in the new part of our study have now commenced their treatment. 
We are particularly impressed with the potency of the EPODURE biopumps from 
these patients, which has enabled them to receive the medium dose using only a 
few biopump units, and with their successful preparation at a remote site 
Biopump processing center, establishing a model for wider future implementation. 
We now look forward to monitoring the haemoglobin response in these patients, 
while recruiting additional patients to the trial in the coming months.   We are 
optimistic that this higher dose will confirm that the middle dose biopumps work 
well and that the therapeutic response is dose dependent and without adverse 
effects. As this is an open trial, we look forward to keeping investors updated 
as we treat additional patients and review the ongoing trial data." 
 
 
 
 
 
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 needle biopsies taken from the lower layer of the 
patient's skin under local anaesthetic, and processed during 10-14 days to 
become 30 mm long tissue "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. The Company is 
developing the Biopump to provide substantially greater safety and reliability 
in protein treatment in a more cost effective manner than experienced with the 
existing injected protein therapies.  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 6-12 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 $87 billion by the end of 2010. Other 
potential applications of Biopumps producing various proteins include multiple 
sclerosis, arthritis, pediatric 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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