TIDMMEDG TIDMMEDU
RNS Number : 2082S
Medgenics Inc
28 November 2012
Press Release 28 November 2012
Medgenics, Inc.
("Medgenics" or "the Company")
Renowned Experts Affirm Potential of Medgenics' INFRADURE
Technology for Treatment of Hepatitis B and D
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the
developer of Biopump(TM) a novel technology for the sustained
production and delivery of therapeutic proteins in patients using
their own tissue, today announced that during the recent annual
conference of the American Association for the Study of Liver
Disease (AASLD) in Boston, it convened an active roundtable of top
liver experts and regulatory advisors from the United States,
Europe, Israel and Australia to discuss INFRADURE(TM), which the
Company is developing to provide sustained interferon therapy for
the treatment of hepatitis. Fifteen key opinion leaders in
hepatitis met to interactively review Medgenics' INFRADURE for its
potential applications in the treatment of hepatitis B and
hepatitis D. The session provided key input reflecting the latest
clinical developments in hepatitis to optimize the clinical
development strategy and regulatory approach for INFRADURE.
INFRADURE is designed to provide sustained interferon therapy
using the patient's own dermis tissue processed to produce and
deliver interferon alpha continuously in the patient for months
from a single treatment. Hepatitis B affects more than 350 million
people worldwide and approximately 1.3 million in the U.S.
Hepatitis D, an aggressive form of hepatitis, affects some 15
million people worldwide, and is estimated to afflict tens of
thousands in the U.S. Hepatitis C affects an estimated 180 million
people worldwide and 3 to 4 million in the U.S.
Nezam H. Afdhal, M.D., Chief of Hepatology, Director of Liver
Center, Beth Israel Deaconess Medical Center and Professor of
Medicine, Harvard School of Medicine, and a member of the Company's
Strategic Advisory Board who helped organize the meeting,
commented, "This group of top leaders in the field of hepatitis
concurred that INFRADURE holds much promise in addressing the unmet
need in the treatment of hepatitis B, namely to eliminate the
hepatitis B virus (HBV), not just contain it. Years of expensive
oral antiviral treatments have not eliminated the HBV. Instead
these treatments have acted to contain the disease as long as the
patient takes them, with mounting costs and health risks. The group
agreed that the gold standard of treating HBV is to eliminate the
hepatitis B surface antigen (HBsAg) by activating the immune system
to fight it, known as sero-conversion - which is attained in only a
small percentage of patients using oral antiviral agents and only
after long-term use. Sero-conversion against HBV and surface
antigen elimination has been reported to be improved by one-to-two
years of interferon alpha therapy. However, today this requires the
patient to endure weekly injections of pegylated interferon alpha
with its associated side effects, creating a significant challenge
in patient compliance to complete treatment. INFRADURE has the
potential to provide a much more practical and patient-compliant
way to attain sero-conversion or surface antigen loss in a large
proportion of patients by having the patient's own tissue produce
and deliver the protein instead of using injections, whether
supplemental to oral treatments, or on its own."
Bruce R. Bacon, M.D., Saint Louis University and past President
of the American Association for the Study of Liver Disease, a
recognized global expert in hepatitis and a member of the Company's
Strategic Advisory Board, reacted to the meeting, saying,
"Colleagues who participated in the meeting and I were particularly
excited about INFRADURE use as a supplement to oral drugs to
address their unmet need to improve HBV surface antigen clearance.
We also concurred that INFRADURE could fulfill an unmet need for
reliable interferon therapy for hepatitis D, a particularly
aggressive form of hepatitis for which years of interferon therapy
is the only effective treatment. Though an orphan disease in the
U.S., our European colleagues pointed out that hepatitis D is
becoming a significant cause of death in Europe. This has now
captured the attention of hepatologists in the U.S., where the
AASLD held its first special session dedicated to hepatitis D this
year. My colleagues agreed that if the upcoming INFRADURE trial in
hepatitis C shows signs of effectiveness, it will also be promising
for its use in hepatitis D as well as hepatitis B."
Andrew L. Pearlman, Ph.D., President and Chief Executive Officer
of Medgenics, added, "Confirmation by this group of esteemed
experts on the potential application of INFRADURE in hepatitis B
and D represents an important milestone for the hepatitis program
using our Biopump(TM) platform. We are extremely appreciative of
their valuable input on our proposed development plans for
INFRADURE."
About Medgenics
Medgenics is developing and commercializing Biopump(TM), a
proprietary tissue-based platform technology for the sustained
production and delivery of therapeutic proteins using the patient's
own skin biopsy for the treatment of a range of chronic diseases
including anemia, hepatitis, and hemophilia, among others.
Medgenics believes this approach has multiple benefits compared
with current treatments, which include regular and costly
injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in
development based on this technology:
-- EPODURE(TM) to produce and deliver erythropoietin from a
single administration, which has demonstrated elevation and
stabilization of hemoglobin levels in anemic patients for periods
of six months to more than 36 months in a Phase I/II dose-ranging
trial in Israel and is currently in a Phase IIa trial in dialysis
in Israel. An Investigational New Drug application has been cleared
by the FDA to initiate a Phase IIb study to evaluate the safety and
efficacy of EPODURE in the treatment of anemia in dialysis patients
in the U.S.
-- INFRADURE(TM) for sustained production and delivery of
interferon-alpha for use in the treatment of hepatitis, which has
received approval for two Phase I/II trials in hepatitis C from the
Israeli Ministry of Health with the first slated to commence in Q4
2012; and has received Orphan Drug Designation from the FDA for the
treatment of hepatitis D.
-- HEMODURE(TM) for sustained production and delivery of
clotting Factor VIII therapy for the sustained prophylactic
treatment of hemophilia is now in development.
Medgenics is focused on the development and manufacturing of its
innovative Biopumps, aiming to bring them to market via strategic
partnerships with major pharmaceutical and/or medical device
companies.
In addition to treatments for anemia, hepatitis and hemophilia,
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 $132 billion in
2013. Other potential applications for Biopumps include multiple
sclerosis, arthritis, pediatric growth hormone deficiency, obesity
and diabetes.
Forward-looking Statements
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and as that term is defined
in the Private Securities Litigation Reform Act of 1995, which
include all statements other than statements of historical fact,
including (without limitation) those regarding the Company's
financial position, its development and business strategy, its
product candidates and the plans and objectives of management for
future operations. The Company intends that such forward-looking
statements be subject to the safe harbors created by such laws.
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.
For further information, contact:
Medgenics, Inc. Phone: +972 4 902 8900
Dr. Andrew L. Pearlman
andrew.pearlman@medgenics.com
Abchurch Communications Phone: +44 207 398 7718
Adam Michael
Joanne Shears
Jamie Hooper
Harriet Rae
mailto:harriet.rae@abchurch-group.com
Nomura Code Securities. (NOMAD & Phone: +44 207 776 1200
Joint Broker)
Jonathan Senior
Giles Balleny
SVS Securities plc (Joint Broker) Phone: +44 207 638 5600
Alex Mattey
Ian Callaway
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
END
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