TIDMMEDG TIDMMEDU
RNS Number : 5145B
Medgenics Inc
17 April 2012
Medgenics Files IND Application for EPODURE Biopump Phase IIb
Anemia Study in Dialysis Patients
First FDA Filing for Biopump in the U.S. Expected to Build Upon
Positive Results from Pre-Dialysis Study
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the
developer of a novel technology for the sustained production and
delivery of therapeutic proteins in patients using their own
tissue, today announced that it has filed an Investigational New
Drug ("IND") application with the U.S. Food and Drug Administration
("FDA") to initiate a Phase IIb multi-center, 100-patient clinical
trial. The trial is designed to evaluate the safety and efficacy of
sustained erythropoietin ("EPO") therapy delivered via the
Company's EPODURE Biopump(TM) for the treatment of anemia in
dialysis patients with end-stage renal disease ("ESRD").
EPODURE is an autologous dermal Biopump, a small tissue implant
made from the patient's own dermal (skin) tissue. EPODURE Biopumps
are processed to enable the continuous production of EPO, and are
subsequently implanted subcutaneously. Positive data from the
Company's Phase I/II dose-ranging study of EPODURE in pre-dialysis
patients were presented at the 2010 and the 2011 American Society
of Nephrology Annual Meetings, and demonstrated that a single
administration can raise and maintain hemoglobin levels for many
months without any injections of EPO or other erythropoietin
stimulating agents ("ESAs").
The filing of this IND application follows two key events that
occurred in March 2012: the regulatory approval for a smaller Phase
IIa study for the same indication in Israel; and positive meetings
with the National Institutes of Health's Recombinant DNA Advisory
Committee in the U.S.
"This IND filing is our first with the FDA and marks a
significant milestone for Medgenics. It is one of many key
catalysts we have targeted for our Company in 2012. We anticipate
receiving the FDA's comments in May, which we believe could lead to
trial approval in the third quarter of 2012," said Andrew L.
Pearlman, Ph.D., President and Chief Executive Officer of
Medgenics. "Filing for the anemia indication of our platform
technology is a key step not only for EPODURE, but helps pave the
way for multiple future indications that address
multibillion-dollar markets."
About Anemia
Anemia is a common result of renal failure primarily caused by
insufficient production of the hormone EPO by the damaged kidneys,
which leads to a decrease in production of red blood cells.
Treatment with EPO typically involves intravenous or subcutaneous
administration by injection at regular intervals followed by
frequent laboratory tests to monitor hemoglobin concentration. Due
to the short half-life of the protein, it is usually administered
at doses that result in supra-physiological levels far above normal
range, which then decline through the range and often drop below it
until the next injection. This variability in levels, particularly
the peak levels far above physiologic range, is in stark contrast
to the gradual changes maintained by the kidneys, and have been
suggested by researchers to increase the risk of adverse
cardiovascular effects and may make maintenance of steady
hemoglobin levels more challenging. EPODURE is designed to provide
a gradual supply of EPO, to follow the natural model and to avoid
the risks that swings in EPO and hemoglobin levels are thought to
increase. The need for frequent injections and laboratory tests,
medication compliance and lifestyle adjustment are potential
barriers to achieving the desired hemoglobin goal. These barriers,
together with the high costs of the currently available recombinant
EPO products, provide an incentive to improve care with a sustained
therapy approach.
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 C and hemophilia. 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 to produce and deliver erythropoietin for many months
from a single administration, has demonstrated elevation and
stabilization of hemoglobin levels in anemic patients for six to
more than 36 months in a Phase I/II dose-ranging trial in CKD
patients, and is about to commence a Phase IIa safety/efficacy
trial in ESRD dialysis patients in Q2 2012 in Israel.
-- INFRADURE(TM) for sustained production and delivery of
interferon-alpha for use in the treatment of hepatitis is awaiting
final approval for two Phase I/II trials in hepatitis C in Israel,
slated to commence Q3 2012.
-- HEMODURE(TM) for sustained production and delivery of
clotting Factor VIII therapy for the 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
LHA Phone: 212-838-3777
Anne Marie Fields
afields@lhai.com
Abchurch Communications Phone: +44 207 398 7719
Adam Michael
Joanne Shears
Jamie Hooper
jamie.hooper@abchurch-group.com
Religare Capital Markets (NOMAD) Phone: +44 207 444 0800
Emily Staples
SVS Securities plc (Joint Broker) Phone: +44 207 638 5600
Alex Mattey
Ian Callaway
Nomura Code Securities (Joint Broker) Phone: +44 207 776 1219
Jonathan Senior
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
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