TIDMMEDG TIDMMEDU
RNS Number : 9444Z
Medgenics Inc
23 March 2012
Press Release 23 March 2012
Medgenics, Inc.
("Medgenics" or the "Company")
MEDGENICS CLEARED TO INITIATE PHASE IIa anemia STUDY OF EPODURE
BIOPUMP IN dialysis PATIENTS IN ISRAEL
Study of New Indication in Dialysis Expected to Build on
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 receipt of clearance from the Israeli
Ministry of Health to initiate a Phase IIa clinical study
evaluating the safety and efficacy of sustained erythropoietin
("EPO") therapy produced and delivered by the Company's EPODURE(TM)
Biopumps(TM). The study will assess EPODURE's ability to replace
months of routine EPO injections for the treatment of anemia in
patients with end-stage renal disease ("ESRD" or "kidney failure")
who are on dialysis.
EPODURE is an autologous dermal Biopump, a small tissue implant
made from the patient's own dermal (skin) tissue, processed to
enable it to continuously produce EPO. EPODURE Biopumps are
subsequently implanted subcutaneously into the patient to provide
continuous delivery of EPO.
"Our EPODURE Biopump technology offers potential advantage over
current therapy because it enables patients to continuously produce
and deliver their own EPO within the normal physiological range.
Sustained delivery of EPO is expected to help keep hemoglobin
within the target range to reduce the risks of hemoglobin
variability, while avoiding the possible risks posed by EPO
concentrations many times the normal physiological range, as
observed with EPO administrations. EPODURE could potentially be a
safer anemia management tool. Additionally, the cost benefits for
the management of anemia could be highly significant," said Andrew
L. Pearlman, Ph.D., President and Chief Executive Officer of
Medgenics.
This open-label Phase IIa study will enroll up to 20 dialysis
patients with anemia due to ESRD who have been receiving routine
EPO injections three times per week. Each patient will receive an
individually targeted initial dose of EPODURE Biopumps designed to
produce levels of EPO that would replace the routine EPO injections
over a period of 4-12 months. The EPODURE dose may be adjusted if
needed by adding or removing Biopumps, emulating the standard care,
dose adjustments, currently made with injected EPO. The study's
objective is to maintain hemoglobin levels within the desired
therapeutic range without the need for EPO injections. The study
will be conducted at the Tel Aviv Sourasky Medical Center by
principal investigator Doron Schwartz, M.D., Head of the Center's
Nephrology Department. The Ministry of Health has approved the
Company's commencement of the recruitment and treatment of
patients, subject to a follow-up safety review on June 19, 2012,
similar to the protocol followed in the Phase I/II pre-dialysis
study.
Dr. Pearlman continued, "We are pleased to have been cleared to
initiate this Phase IIa study in dialysis patients, which we expect
will build on the positive clinical results from our earlier Phase
I/II study of EPODURE to treat pre-dialysis patients with chronic
kidney disease. This is the first clinical study that will permit
adjustment of the EPODURE dose based on patients' needs as is
currently done in standard EPO treatment, and will be standard in
future EPODURE use. This represents a significant change from the
fixed-dose study we previously conducted in pre-dialysis
patients.
"This is the second EPODURE study to be approved by Israel's
regulatory agency and will be conducted at the same medical center,
with the same principal investigator as our previous study. We
believe this indicates growing confidence with the EPODURE Biopump
in the treatment of anemia, and supports our clinical strategy. As
ESRD patients represent the largest market segment in renal anemia,
we look forward to initiating our first clinical trial in dialysis
patients and are confident that the Phase IIa study results will
affirm the positive data from our study of EPODURE in pre-dialysis
patients 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"). In
parallel with this new Phase IIa trial in Israel, we are on track
to file an Investigational New Drug application for a larger Phase
IIb trial in the U.S. and, subject to U.S. Food and Drug
Administration approval, look forward to obtaining clearance for
that trial later this year," concluded Dr. Pearlman.
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, 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 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(TM) (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) Limited Phone: +44 207 444 0542
(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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