CLINICAL TRIAL AND STRATEGIC PARTNER UPDATE
August 27 2009 - 4:11AM
UK Regulatory
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
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this release may not occur.
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