MEDG Medgenics(Regs)

 

TIDMMEDG 
 
RNS Number : 1018Y 
Medgenics Inc 
27 August 2009 
 
Medgenics, Inc. 
('Medgenics' or the 'Company') 
PATIENT NEARING UNPRECEDENTED 11 MONTHS OF ANEMIA RELIEF IN CLINICAL TRIAL FROM 
SINGLE TREATMENT OF BIOPUMP TISSUE TECHNOLOGY 
NEWS FOLLOWS SIGNIFICANT INTEREST OF STRATEGIC PARTNER FOR NEW APPLICATION 
  *  EPODURE patient approaching 11 months continuous anemia relief from single 
  treatment, and reaching one year anniversary without any injections of EPO; 
  *  Significant new interest from major pharmaceutical companies to develop a 
  Biopump for new applications; 
  *  Serious new interest from institutional investors; and 
  *  Medgenics awarded $1.3 million Israeli government grant. 
 
August 27, 2009 - Medgenics (AIM:MEDG, MEDU) is pleased to announce that one of 
the patients, who was treated with the Company's EPODURE tissue Biopumps almost 
11 months ago, continues to be effectively treated for anemia without a single 
erythropoietin (EPO) injection. This patient (#2) was dependent on frequent 
injections of the therapeutic protein (EPO)  for the 18 months prior to 
receiving a single administration of 3 tiny EPODURE tissue Biopumps in the 
Company's phase I/II anemia trial in Israel. He has now gone a full year since 
his last EPO injection, while his hemoglobin level has been continuously 
maintained within the target range of 10-12 g/dl for this period. By contrast, 
conventional anemia treatment by EPO injections must be repeated up to 3 times 
every week to provide sustained treatment. To the best of the Directors' 
knowledge, nothing approaching EPODURE'S length of sustained anemia relief in 
patients has been shown from a single treatment of any other kind. 
 
 
The patient (#2), stated: 
"For me the treatment has been and continues to be successful, without 
complications or discomfort. At 72 years old, I continue to do physical work in 
the citrus groves several hours a day, but unlike in the previous year, I have 
not needed injections. The treatment has improved my quality of life." 
 
 Medgenics' unique tissue-based EPODURE Biopump platform technology is 
proving to be effective in maintaining hemoglobin levels within the target range 
for many months in most of the patients treated so far, even at lowest dose of 
treatment, according to internationally renowned nephrologist, Dr. Anatole 
Besarab, who is a member of Medgenics' Scientific Advisory Board.The Company 
plans to present the study findings at the upcoming American Society of 
Nephrology meeting in October. 
 
 Dr. Besarab has said: 
"With a patient now nearing 12 months without EPO injections and others for more 
than 6 months, it is becoming clearer that the EPODURE Biopump is able to 
produce sufficient erythropoietin to effectively elevate and then sustain 
hemoglobin levels in patients with sufficient administered dose.I am not aware 
of any other technology that can achieve such prolonged and sustained therapy 
from a single treatment. Additional studies are needed in a broader range of 
patients, and we look forward to them to further confirm these very positive 
results." 
 
 
 
Medgenics has also recently moved significantly ahead in discussions with major 
pharmaceutical companies and  with  institutional investment funds. 
Advanced discussions are now underway towards potential partnership in the 
coming months to co-develop a Biopump  producing Factor VIII protein for the 
treatment of hemophilia, a market greater than $3.5b/year (La Marie 2007).  In 
addition, the Company has recently entered advanced discussions with 
institutional investors interested in multimillion dollar investment in 
Medgenics in the coming months. Medgenics is also in active due diligence with 
an Asian biopharma company that has conveyed its written interest in a 
combined investment in the Company and licensing agreement for 
  collaboration in certain Biopump applications in selected Asian markets to be 
agreed. The Board is also pleased by  recent serious interest by companies in 
other new applications of the Biopump platform, and believes that such 
interest  demonstrates the attractiveness of the Biopump platform for strategic 
partners. 
The Directors believe that these discussions could lead to concrete steps in the 
coming months. 
In addition to the closing and commitment of additional funds announced last 
week, which brought the total to $520,000, Medgenics notes that it was awarded a 
government grant in Q2/09 of $1.3 million from the Office of the Chief Scientist 
(OCS) at the Ministry of Industry, Trade and Labor of Israel. These funds will 
be received as government participation in approved R & D expenses incurred 
during the period April 2009 to March 2010. The OCS awards grants to industry in 
Israel to advance technological innovations. This is the fourth consecutive year 
that Medgenics has received this respected grant. 
Dr. Andrew Pearlman, CEO of Medgenics said 
"We are excited that we have a patient who is now reaching a full year of 
effective anemia treatment without any EPO injections and with only a single 
treatment of EPODURE. In this period a typical patient in the U.S. being treated 
per the FDA guidelines for EPO administration would receive up to 
150 injections.  Month by month we have drawn growing encouragement from the 
continuing positive results of the Biopump anemia study. We are pleased by the 
significant progress with potential partners and institutional investors which 
gives us great hope that this will yield concrete results in the coming months. 
Meanwhile, the Company continues its focused efforts to raise several million 
US$ in the coming months to enable it to continue and expand the clinical trial 
and our other operations and to realize the potential of the great opportunities 
it now has." 
The Company would also like to clarify that, further to the announcement made on 
20 August 2009, included within the $55,000 debenture investment by 
"shareholders who are physicians with expertise in the clinical field addressed 
by Medgenics' lead product, EPODURE" was an investment of US $5,000 from Stephen 
McMurray, a director of the Company. 
 
 
 
 
For further information, contact: 
 
Medgenics, Inc.+972 4 902 8900 
Dr. Andrew L. Pearlman 
 
Blomfield Corporate Finance (Nominated adviser)+44 207 489 4500 
James Pinner or 
Alan MacKenzie 
 
SVS Securities plc (Broker)                                 +44 207 638 5600 
Ian Callaway 
 
Grayling Global     (Financial PR)+44 7900 053 536 
Jonathan Shillington   jonathan.shillington@uk.grayling.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. 
The Biopump is a toothpick sized sliver of the patient's own dermal tissue 
obtained under local anesthetic, that has been processed within 2 weeks to 
become a unit producing a selected protein for a specific clinical 
application.Injected under the skin, the Biopump produces and delivers the 
therapeutic protein to the patient for several months. 
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 10 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 2009/10 to commence a Phase 
I/II trial of INFRADURE in Hepatitis-C patients in Israel during 2010.  The 
Company hopes that partnering discussions will lead to collaboration also in the 
next stage of EPODURE development, likely to be a Phase IIb multicenter study in 
anemic patients. 
 
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 
 
 MSCGCGDIXGDGGCR 
 

Medgenics(Regs) (LSE:MEDG)
Historical Stock Chart
From Jun 2024 to Jul 2024

Medgenics(Regs) (LSE:MEDG)
Historical Stock Chart
From Jul 2023 to Jul 2024