MEDG Medgenics(Regs)

 

TIDMMEDG 
 
RNS Number : 8434K 
Medgenics Inc 
27 April 2010 
 
 
 
 
 
 
 
 
 
                                Medgenics, Inc. 
                         ('Medgenics' or the 'Company') 
 
 MEDGENICS GRANTED APPROVAL FOR EXTENSION OF ANAEMIA TRIAL TO MAJOR NEW MEDICAL 
                                    CENTRE 
 
Misgav, Israel and London, UK -27 April 2010 - Medgenics (AIM: MEDG, MEDU) is 
pleased to announce that it has received approval from Israel's Ministry of 
Health (MOH) to proceed with higher dose groups in the phase I-II clinical trial 
of its novel sustained anaemia treatment, EPODURE, at an additional new site, 
the Tel Aviv Sourasky Medical Centre, one of the largest teaching hospitals in 
Israel. Following the first closing of the Company's interim fund raising, as 
announced on 5 March 2010, patient recruitment will commence shortly for the new 
centre, with the first patients expected to receive their Biopumps within a few 
weeks of enrollment. Medgenics has already reported sustained anaemia treatment 
of unprecedented duration from a single treatment in most patients in the low 
dose group in this study and hopes to prove the efficacy of EPODURE further in 
this higher dose study. 
 
The new higher dose study groups aim to assess the safety and efficacy of 
EPODURE at increased, controlled dose ranges, noting that among the seven 
patients already treated in the Company's clinical trial to date, no signs of 
adverse reactions have been noted, and all patients tolerated all study 
procedures very well.  From the clinical efficacy perspective, the six patients 
in the low dose group received sufficient EPODURE Biopumps to provide the lowest 
recommended dosage of erythropoietin (EPO) on a continuous basis:  20 EPO units 
or IU/kg/day.  All patients showed delivery of active EPO, with most showing 
sustained elevation of haemoglobin levels (the primary endpoint) in the target 
range of 10-12 g/dl for 6-12 months, without receiving any further injections of 
EPO.  One of these patients maintained haemaglobin levels in the normal range 
for more than 18 months without any EPO injections.  The seventh patient has 
already received the midrange dose of 40 IU/kg/day and also maintained 
haemoglobin levels for six months without adverse events. 
 
Medgenics' unique platform approach to providing safer, more effective and lower 
cost protein therapy uses the patient's own tissue to act as a biological pump 
or "Biopump" to continuously produce their own therapeutic proteins.  Needle 
biopsies are taken from the lower layer of the patient's skin under local 
anesthetic, and processed during 10-14 days to become tissue biofactories 
producing the required protein. The requisite number of Biopumps are then 
injected under the patient's skin to provide sustained protein production and 
delivery for many months. 
 
In the next dose group of the study, sufficient EPODURE Biopumps will be 
administered to each patient to provide 40 IU/kg/per day  or 60 IU/kg per day, 
which may enable more of the patients to maintain haemaglobin in the target 
range for extended periods of time.   Dr. Doron Schwartz, Head of the Nephrology 
department at the centre, as the new Principal Investigator, has already 
recruited the active support of his department for the study. 
 
 
Commenting on the approval, Dr. Andrew Pearlman, Chief Executive Officer of 
Medgenics, said: 
 
"The extension of our study to one of Israel's largest and most prestigious 
medical centres is an important milestone for EPODURE and the Medgenics Biopump 
platform technology for the continuous production and delivery of therapeutic 
proteins in the patient.  This important step has been made possible by the 
encouraging results achieved to date, together with the first closing of our 
current round of fundraising, and we look forward to moving ahead on this and 
other steps in our program as additional funds are raised in the coming months. 
 
The enthusiastic involvement of Dr. Schwartz and his department is particularly 
welcomed as we proceed towards completion of this trial in a timely manner, and 
we hope that we will now have more rapid patient recruitment than we have had to 
date. 
 
Given the very encouraging results at low dose levels, we are looking much 
forward to seeing the results from the higher doses in this trial." 
 
 
For further information, contact: 
 
+----------------------------------+--------------------------+ 
| Medgenics, Inc.                  | Phone: +972 4 902 8900   | 
| Dr. Andrew L. Pearlman           |                          | 
|                                  |                          | 
+----------------------------------+--------------------------+ 
| De Facto Communications          | Phone: +44 207 861 3838  | 
| Mike Wort                        |                          | 
| Anna Dunphy                      |                          | 
|                                  |                          | 
+----------------------------------+--------------------------+ 
| Religare Capital Markets (Nomad) | Phone: +44 207 444 0800  | 
| James Pinner                     |                          | 
| Derek Crowhurst                  |                          | 
|                                  |                          | 
+----------------------------------+--------------------------+ 
 
+----------------------------------+--------------------------+ 
| SVS Securities plc (Broker)      | Phone: +44 207 638 5600  | 
| Alex Mattey                      |                          | 
| Ian Callaway                     |                          | 
|                                  |                          | 
+----------------------------------+--------------------------+ 
 
 
 
 
NOTES TO EDITORS: 
 
Medgenics is a pre-revenue, commercialization stage biopharmaceutical company 
developing its unique tissue-based Biopump platform technology capable of 
producing and delivering months of sustained protein therapy.  A single 
administration of Biopump has already been shown to provide at least 6-12 months 
of safe, effective, treatment in its first application in patients. Biopumps 
could potentially provide safer, more effective and lower cost treatment for a 
wide range of chronic diseases.  The Company, which has signed its first 
commercial development agreement with a major Pharmaceutical company which is 
now in progress, currently has three products in development based on this 
technology and addressing the indications of: 
- Anaemia - using EPODURE, a Biopump producing erythropoietin (EPO) - Has proven 
concept in clinical trials. 
- Hepatitis-C - using INFRADURE - a Biopump producing interferon-alpha (IFN-a) 
- Proven in the lab, in preclinical preparations. 
- Haemophilia - using a Biopump to produce clotting Factor VIII - under 
development with a major Pharmaceutical company that is a leader in the 
haemophilia market. 
In the Company's Phase I/II clinical trial using EPODURE to treat anaemia in 
patients with chronic kidney disease, 6-12 months of effective anaemia treatment 
from a single treatment of a few Biopumps has already been shown in most of the 
patients treated, even at the lowest administered dose.  Taken together with the 
EPODURE results, the production of IFN-a by INFRADURE demonstrates that the 
Biopump is a platform for sustained protein therapy in a range of applications. 
While developing its innovative products, Medgenics has already reached its 
first commercial development agreement in its strategy of forging multiple 
strategic partnerships with major pharmaceutical and/or medical device companies 
to bring products thru final approval and sales. Medgenics is developing its 
core technology to implement automated Biopump processing stations employing 
single use cassettes, to enable practical and cost-effective scale-up for 
commercial implementation.  In addition to treatments for Anaemia, Hepatitis-C, 
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, forecast to exceed US $80 billion in 2010.  Other pipeline Biopump 
applications include multiple sclerosis, obesity, diabetes, arthritis, and 
paediatric growth hormone deficiency, among others. 
 
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 
   END 
 
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