MEDG Medgenics(Regs)

 

TIDMMEDG 
 
RNS Number : 6698M 
Medgenics Inc 
03 February 2009 
 
 
 
 
Medgenics, Inc. 
('Medgenics' or the 'Company') 
 
MEDGENICS ANNOUNCES POSITIVE DATA FROM PHASE I/II CLINICAL 
TRIAL OF EPODURE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE 
 
  *  EPODURE Biopump demonstrates safety and efficacy for four months with single 
  administration 
  *  Institutional Review Board confirms safety and efficacy of low dose and approves 
  continuation of trial with higher doses 
  *  Biopump may offer alternative to months of expensive injections 
 
 
Misgav, Israel and London, UK - 3 February, 2009 - Medgenics (AIM: MEDU/MEDG), 
today announces that the EPODURE Biopump, the Company's unique tissue-based 
technology, has successfully demonstrated safety and efficacy for the sustained 
protein therapy of anemia in patients with chronic kidney disease (CKD). 
In the Company's ongoing Phase I/II clinical trial, a one-time administration of 
EPODURE, producing and delivering the low dose of 18-25 IU/kg/day of the protein 
erythropoietin (EPO), was sufficient to sustain therapeutic elevation of 
hemoglobin in most patients. The earliest patients to receive treatment have 
shown sustained hemoglobin within the target range for four months without 
receiving any EPO injections.   By contrast, in standard practice today, EPO 
injections are required up to several times per week, and the comparable low 
dose does not result in sufficient hemoglobin levels in most patients. 
By having maintained hemoglobin levels in the target range for several months in 
more than one patient, the study has already demonstrated that when administered 
at an appropriate dose for the patient, EPODURE can provide sustained anemia 
treatment for at least four months while alleviating the need for frequent EPO 
injections. 
The Phase I/II clinical trial was approved for three escalating dose groups, 
beginning with six patients at the lowest dose, and called for a safety review 
after treatment of these first six patients prior to treatment using higher 
doses. The Institutional Review Board (IRB) of Hadassah Hebrew University 
Hospital in Jerusalem, Israel, where the study is being conducted, has now 
reviewed the results for this first group of patients and has confirmed the 
safety and efficacy of EPODURE at the low dose and approved the continued 
recruitment and treatment of patients in the trial using higher EPODURE doses, 
Even with the low dose, the hemoglobin levels of most of the patients have 
remained within 10-12 grams per deciliter, the target range indicated by FDA 
guidelines for CKD patients, with no adverse effects reported or observed. Five 
of the six patients have now had EPODURE for more than one month, with target 
range having been maintained for four months in two of them, and for more than a 
month thus far in another.  The results from the patients to date indicate that 
EPODURE is safe and well tolerated and suggests that it can provide effective 
treatment of chronic anemia. 
Commenting on the results, Dr. Andrew Pearlman, Chief Executive Officer of 
Medgenics, said, 
"This is a very exciting and important milestone for the Company, particularly 
because we have shown such a clear effect in most patients, even in the lowest 
dose group of our trial.  The fact that hemoglobin levels continue to show 
sustained elevation in most of these patients indicates the immune acceptance of 
the implanted EPODURE Biopumps, and suggests that in the right dose for a given 
patient, we can indeed treat anemia effectively for at least four months with a 
single EPODURE treatment without the need for additional EPO injections. This 
strongly supports the Directors' belief that the EPODURE Biopump can be an 
effective long-term treatment for anemia. We look forward to seeing EPODURE's 
performance in the next group of patients who will be receiving higher doses." 
Professor Eugene Bauer, MD, Dean Emeritus, Stanford University School of 
Medicine and Chairman of Medgenics commented: 
"This is a groundbreaking study. These continuing results demonstrate that 
EPODURE can provide a sustained therapy for anemia. We are aware of no other 
anemia therapy that has demonstrated maintenance of hemoglobin levels for months 
from a single treatment. Our results thus far appear to offer a major advantage 
over current therapies and to represent a paradigm shift in the treatment of 
anemia. More generally, these results suggest that Medgenics' Biopump may offer 
the first practical treatment to provide sustained protein therapy and serve as 
an alternative to expensive, bolus injections of proteins mass-produced in 
animal cells." 
Medgenics' Biopump is a unique tissue-based platform technology that processes a 
toothpick sized sliver of the inner layer of the subject's skin and is intended 
to provide sustained-action protein therapy for the treatment of a range of 
chronic diseases, including Hepatitis C, hemophilia, and multiple sclerosis. The 
technology represents a major advancement over today's protein therapy which 
involves frequent, costly, and painful bolus injections. A breakthrough in 
personalized medicine, the Biopump is intended to increase efficacy, reduce side 
effects, and improve patient compliance and quality of life, as well as lower 
treatment costs and extend treatment to populations currently under-treated. 
Medgenics intends to develop its technology for a variety of chronic conditions, 
initially focusing on anemia and hepatitis C, with the intent to bring it to 
market via multiple strategic alliances in the relevant therapeutic space. The 
Company is in active discussions with major potential strategic partners for one 
or more applications. 
"We are excited by the continued and sustained positive trial results, as well 
as the strong interest we are receiving from several potential partners," 
concluded Dr. Pearlman. "The EPODURE Biopump represents the first of a line of 
Biopump products designed to vastly improve the treatment of chronic diseases." 
 
For further information, contact: 
+---------------------------------------------+----------------------------------------+ 
| Medgenics, Inc.                             | Phone: +972 4 902 8900                 | 
| Dr. Andrew L. Pearlman                      |                                        | 
|                                             |                                        | 
+---------------------------------------------+----------------------------------------+ 
| Grayling Global (Financial PR, UK)          | Phone: +44 7900 053 536                | 
| Jonathan Shillington                        |                                        | 
| 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                | 
| Peter Manfield                              |                                        | 
| Ian Callaway                                |                                        | 
|                                             |                                        | 
+---------------------------------------------+----------------------------------------+ 
| Grayling Global United States               | Phone: +1 646 284 8472                 | 
| Leslie Wolf-Creutzfeldt, Investor Relations | Email: lwolf-creutzfeldt@hfgcg.com     | 
|                                             |                                        | 
+---------------------------------------------+----------------------------------------+ 
| Ivette Almeida, Media Relations             | Phone: +1 646 284 9455                 | 
|                                             | 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 has demonstrated proof of concept of the Biopump treatment procedure 
in a clinical trial of EPODURE in anemic subjects. The Company's Phase I/II 
clinical trial for its long-acting version of EPODURE, designed to produce and 
deliver a therapeutic dose of EPO steadily for six months or more commenced in 
August 2008. Medgenics plans to follow with a clinical trial of INFRADURE in 
2009. 
 
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. 
 
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-�), 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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