TIDMMEDG TIDMMEDU
RNS Number : 0394A
Medgenics Inc
26 March 2012
MEDGENICS REPORTS POSITIVE MEETING WITH NIH RECOMBINANT DNA
ADVISORY COMMITTEE
Clears Important Hurdle Toward U.S. Phase II Clinical Trial of
EPODURE for Sustained Treatment of Anemia in Kidney Disease
Patients on Dialysis
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 received formal notification of
recommendations from the National Institutes of Health ("NIH")
Recombinant DNA Advisory Committee ("RAC") reflecting the Company's
successful presentation of study findings during a meeting held on
March 8, 2012. Completion of the RAC process is an important step
in advancing toward the Company's proposed U.S. Phase II clinical
study evaluating the safety and efficacy of sustained
erythropoietin ("EPO") therapy delivered via the Company's
EPODURE(TM) Biopump(TM) for the treatment of anemia in dialysis
patients with end-stage renal disease ("ESRD").
The RAC meeting was attended by an audience from the general
public and was webcast live. An archive of this webcast is
available at http://videocast.nih.gov/summary.asp?Live=11074 .
EPODURE is an autologous dermal Biopump capable of the sustained
secretion of therapeutic EPO in the body using a small tissue
explant from the patient's own skin. The EPODURE Biopump is
subsequently implanted subcutaneously into the patient to provide
continuous delivery of EPO.
"We are delighted that the RAC has given such positive responses
regarding our proposed Phase II clinical protocol for EPODURE to
treat ESRD and we have already addressed most of their
recommendations in our study planning," said Andrew L. Pearlman,
Ph.D., President and Chief Executive Officer of Medgenics.
"Clinical trials involving recombinant DNA products intended to be
conducted in the U.S. generally need to satisfy review by the RAC,
which is widely recognized as a most thorough scientific and
clinical review by leading experts in relevant areas. Key to this
positive response was the safety and sustained clinical activity we
showed from the EPODURE Phase I/II trial conducted in Israel. We
believe the RAC recommendations can be incorporated into our
proposed protocol without difficulty and will not pose any
significant delay or expense. Following a positive
pre-Investigational New Drug ("IND") application meeting with the
U.S. Food and Drug Administration ("FDA") last fall, completion of
the RAC process clears an important hurdle toward the successful
submission of our IND application and is a significant step in
implementing our clinical strategy.
"We look forward to submitting our IND to the FDA in the coming
months and to obtaining FDA clearance for our Phase II clinical
trial, which we expect will affirm the positive results from our
earlier Phase I/II study of EPODURE in pre-dialysis patients,"
added Dr. Pearlman. "In that study we demonstrated that a single
administration can raise and maintain hemoglobin levels for many
months without any injections of erythropoietin stimulating
agents."
About Anemia
Anemia is a common complication of renal failure resulting
primarily from 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 super physiological
levels, which then decline into a more physiologic range. This
variability in levels, and in particular the peak levels which then
decline into a more physiologic range. This variability in levels,
and in particular the peak levels, has been hypothesized to
potentially increase the risk of adverse cardiovascular effects and
may make maintenance of steady hemoglobin levels more challenging.
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 the National Institutes of Health Recombinant DNA Advisory
Committee
The objective of the Recombinant DNA Advisory Committee is to
provide advice to the Director of the NIH on matters related to the
conduct and oversight of research involving recombinant DNA,
including the content and implementation of the NIH Guidelines for
Research Involving Recombinant DNA Molecules and other NIH
activities pertinent to recombinant DNA technology. The RAC
comprises experts in a wide range of scientific and medical
disciplines and also includes medical ethicists and members of
patient and other lay communities. Because of the dedication,
effort, and thoughtful contributions of its members over the past
30 years, the RAC has been a vital national forum promoting
critically important scientific progress in a transparent,
responsible, and safe manner and enhancing public trust in the
science.
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 (now completing a Phase I/II dose-ranging trial) 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;
-- INFRADURE(TM) (planning to commence a Phase I/II trial in
Israel in 1H12 in hepatitis C) to produce a sustained therapeutic
dose of interferon-alpha for use in the treatment of hepatitis;
-- HEMODURE(TM) is a sustained Factor VIII therapy for the
prophylactic treatment of hemophilia, now in development.
Medgenics intends to develop its innovative products and 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
@LHA_IR_PR
Abchurch Communications Phone: +44 207 398 7719
Adam Michael
Joanne Shears
Jamie Hooper
jamie.hooper@abchurch-group.com
Religare Capital Markets UK Ltd. Phone: +44 207 444 0800
(NOMAD)
David Porter
Richard Thompson
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
END
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