TIDMMEDG TIDMMEDU
RNS Number : 5697D
Medgenics Inc
17 May 2012
Press Release 17 May 2012
Medgenics Receives FDA Clearance to Commence Phase IIb Trial of
EPODURE for Sustained Anemia Treatment in Dialysis Patients
First U.S. Study with Company's Biopump Platform Marks Major
Milestone
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the
"Company"), developer of the novel Biopump(TM) technology for the
sustained production and delivery of therapeutic proteins in
patients using their own tissue, today announced receipt of
clearance from the U.S. Food and Drug Administration ("FDA" or the
"Agency") to proceed with a Phase IIb clinical trial of EPODURE(TM)
for the treatment of anemia in patients undergoing renal dialysis.
EPODURE is intended to produce and deliver erythropoietin ("EPO")
on a sustained basis. This multi-center, randomized clinical trial
will be the first study in the U.S. using the Company's proprietary
Biopump(TM) technology, and will evaluate the safety and efficacy
of sustained EPO therapy delivered via Medgenics' EPODURE Biopump.
Treatment of anemia in dialysis patients with EPODURE is intended
to replace frequent injections of EPO or other erythropoietic
stimulating agents ("ESAs").
"This timely acceptance of our first Investigational New Drug
("IND") to the FDA marks a significant milestone for our Biopump
protein platform. We are very pleased with our U.S. regulatory
progress and with the interactions with the FDA , allowing us to
proceed with the launch of our first U.S. trial," stated Andrew L.
Pearlman, Ph.D., Chief Executive Officer of Medgenics. "This trial
is significant for Medgenics as a company as well as for patients
with anemia, as we anticipate EPODURE could provide a better
treatment for anemia in the future."
"We are hopeful that the positive interaction with the FDA for
EPODURE bodes well for the Agency's approach to other future
indications for our Biopump protein delivery platform technology,"
added Dr. Pearlman.
The FDA cleared the Phase IIb study protocol based on results
from the Company's prior Phase I/II anemia study of EPODURE in
Israel, which reported safety and maintenance of hemoglobin for
months from a single EPODURE treatment in pre-dialysis patients
without requiring injections of EPO or ESAs, as well as on the
complete preclinical package. The Company was particularly
encouraged that clearance was received within the 30-day required
regulatory response period from submission of the IND application
and without major issues being raised. Medgenics views this as an
early, second validation from an independent critical review in the
U.S. of its Biopump platform. The Company announced in March that
the National Institutes of Health's Recombinant DNA Advisory
Committee had given positive responses to the Company's prior
scientific and clinical data and its proposed Phase IIb study
protocol.
The Company believes EPODURE has the potential to revolutionize
the treatment of anemia by stabilizing hemoglobin levels within a
safe range. This approach is designed to keep serum EPO levels
within their normal physiological range and avoid excessive levels
resulting from bolus EPO injections. This could be important in
improving safety and addressing market concerns about the effects
of excessive levels of EPO used in the treatment of anemia.
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 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, and has
received approval of a Phase IIa trial in dialysis patients due to
launch in Q2 2012 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 is awaiting
final approval of two Phase I/II trials in Israel in hepatitis C,
slated to commence in Q3 2012, and is filed for Orphan Drug
Designation with the FDA to treat 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
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
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
END
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