MEDG Medgenics(Regs)

 

TIDMMEDG 
 
RNS Number : 5911P 
Medgenics Inc 
27 March 2009 
 
 
 
 Medgenics, Inc. 
('Medgenics' or the 'Company') 
 
MEDGENICS' PHASE I/II CLINICAL TRIAL NOW SHOWS EPODURE CONTINUOUS 
 
 ANEMIA TREATMENT LASTING 5 MONTHS IN KIDNEY DISEASE PATIENTS 
 
  *  Results to be presented at Israel Society of Nephrology Conference 
  *   EPODURE safety and efficacy now reach 5 months from single treatment 
  *   Data continue to indicate that Biopump may offer alternative to scores of 
  expensive injections 
 
 
March 27, 2009 - Medgenics (AIM: MEDG) is pleased to announce that the 
latest, encouraging results of the Company's ongoing EPODURE Biopump Phase I/II 
Clinical Trial will be presented at the 45th Conference of the Israeli Society 
of Nephrology and Hypertension, in Israel on March 27, 2009. 
 The latest results of the trial show that in the first 2 of the patients 
treated, the hemoglobin level has now remained continuously in the target range 
of 10-12 g/dl for more than 5 months following a single EPODURE treatment using 
the lowest dose of 20 IU/kg/day, thus effectively treating their anemia without 
receiving any injections of erythropoietin (EPO) during this period. One of the 
patients received his last EPO injection more than 200 days ago.  This is 
contrasted with the FDA approved standard regimen of thrice weekly EPO 
injections, in which typical patients would expect to receive up to 85 
injections in this timeframe. 
 A total of 7 patients have now been treated, with 6 patients receiving 
treatment for more than one month.  The seventh patient is the first to 
receive the higher dose of 40 IU/kg/day, which is double that of the lowest 
dosage, and the higher dose treatment is proceeding smoothly. There continue to 
be no adverse events reported in the study. Patient recruitment continues for 
the higher dose treatment. 
 The new data will be presented at the conference by Dr. Michal Dranitzki 
Elhalel, the principal nephrologist of Medgenics' EPODURE Phase I/II clinical 
trial, currently taking place at the Hadassah Hebrew University Hospital in 
Jerusalem, Israel. 
The trial's sponsors and Principal Investigators are now seeking approval to 
broaden the study to include dialysis patients as well as pre-dialysis patients. 
 More information on this will be announced as developments proceed. 
 The Company's active discussions with major potential strategic partners have 
expanded since the announcement in February, with additional companies having 
expressed interest in one or more applications. 
 For further information, contact: 
+----------------------------------------+----------------------------------------+ 
| Medgenics, Inc.                        | Phone: +972 4 902 8900                 | 
| Dr. Andrew L. Pearlman                 |                                        | 
|                                        |                                        | 
+----------------------------------------+----------------------------------------+ 
| Grayling (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                | 
| Ian Callaway                           |                                        | 
|                                        |                                        | 
+----------------------------------------+----------------------------------------+ 
| United States contacts:                |                                        | 
| Grayling, Investor Relations           |  Phone: +1 646 284 8472                | 
| Leslie Wolf-Creutzfeldt                | Email: lwolf-creutzfeldt@hfgcg.com     | 
+----------------------------------------+----------------------------------------+ 
|                                        |                                        | 
| Grayling, Media Relations              | Phone: +1 646 284 9455                 | 
| Ivette Almeida                         | Email: 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 anemia 
  *  INFRADURE - producing interferon-alpha (IFN-a) to treat Hepatitis-C 
 
 The Company's ongoing Phase I/II clinical trial for EPODURE in anemic patients 
continues to demonstrate proof of concept of the Biopump.  Designed to produce 
and deliver a therapeutic dose of EPO steadily for up to six months or more, 
EPODURE Biopumps are already maintaining effective anemia treatment for more 
than 5 months in earliest patients in the ongoing study, even with low dose 
administered. 
 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. 
Medgenics plans to raise the requisite funds during 2009 to enable it to follow 
the current trial of EPODURE with a Phase IIb clinical trial in the US starting 
in 2010, and in addition, to commence a Phase I/II trial of INFRADURE in 
Hepatitis-C patients in Israel also during 2010. 
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-ß), hemophilia (Factor VIII), pediatric 
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 the London AIM in December 2007 (AIM: 
MEDG and AIM: MEDU). 
 
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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