TIDMMEDG TIDMMEDU
RNS Number : 8792H
Medgenics Inc
17 July 2012
Press Release 17 July 2012
First Subjects Enrolled in Phase IIa Clinical Trial of EPODURE
Biopumps to Treat Anemia in Patients with End-Stage Renal Disease
on Dialysis
MISGAV, Israel and SAN FRANCISCO (July 17, 2012) - Medgenics,
Inc. (NYSE MKT: 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, announces the launch of its Phase IIa clinical trial in
Israel of EPODURE(TM) Biopumps to treat anemia in patients with
end-stage renal disease ("ESRD" or "kidney failure") on dialysis,
through the sustained delivery of erythropoietin ("EPO"). Following
the Israeli Ministry of Health's recent approval of the trial,
Medgenics has enrolled and begun to treat the first two dialysis
patients ever to receive EPODURE Biopumps.
Enrollment is expected to continue in the coming months, with up
to 20 patients being treated with EPODURE Biopumps. The study will
evaluate the ability of EPODURE Biopumps to replace most or all of
the injections of EPO or other erythropoietic stimulating agents
("ESAs") currently used in standard care, while maintaining the
patient's blood hemoglobin level within the desired range. The
current standard of care involves years of frequent EPO or ESA
injections, which require patient compliance to reliably administer
the drug during that time. Each injection is short-lived, typically
causing extreme transient elevation of EPO in the patients' blood,
followed by decline to ineffective levels within a few days, so the
patient is not receiving sufficient drug until the next injection.
The high transient levels of EPO in the blood are a source of
safety concern to the U.S. Food and Drug Administration ("FDA") as
well as to many medical experts.
Medgenics' EPODURE Biopumps aim to provide a cost effective way
to maintain hemoglobin within a target physiological range for
these patients through the sustained delivery of EPO, which avoid
the extreme elevations seen with injection. Medgenics believes that
this steady delivery could improve the safety and efficacy of
anemia treatments while enhancing patient quality of life, by
providing a more reliable treatment that reduces or eliminates the
need for frequent EPO or ESA injections, while also providing
significant cost benefits to payers.
In a prior Phase I/Phase II study with EPODURE Biopumps,
Medgenics treated pre-dialysis patients with chronic kidney
disease. That study, which only allowed for a single fixed dose to
each patient, showed that a single administration of EPODURE
Biopumps successfully raised or maintained hemoglobin in the
therapeutic range for six to 36 months without the need for EPO or
ESA injections, while serum EPO levels remained within normal
range. This latest Phase IIa study allows for an adjustment of the
initial dose based on the patient's response to the prior EPO
injections, which the administration of EPODURE Biopumps aims to
replace for many months at a time.
For the first two patients in the current study, the EPODURE
procedure has gone well, as in the previous study, and EPO
concentrations were confirmed to be elevated within normal range in
the patients' blood in the days following EPODURE administration.
This is consistent with the Phase I/Phase II findings, which
indicated that EPODURE Biopumps were delivering EPO in the
patients. Moving forward, patients will be followed to determine
how long their hemoglobin levels remain in the desired range while
EPO levels remain within normal range.
"Our planned Phase II studies will provide valuable insight into
extending the use of EPODURE from treating anemia in pre-dialysis
patients to treating the anemia of dialysis patients - the largest
segment of the anemia market. Although it is very early, we are
pleased to see that EPODURE is performing similarly in dialysis
patients as it did in pre-dialysis patients, providing us further
confidence in EPODURE and in the Biopump platform. While we
continue our Phase IIa study in Israel, we are preparing for the
launch of the larger, Phase IIb study in dialysis patients in the
U.S. before the end of this year. Once completed, we believe that
these studies will provide data to support the use of EPODURE in
the treatment of anemia from chronic kidney disease," stated Andrew
L. Pearlman, Ph.D., President and Chief Executive Officer of
Medgenics.
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, 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 has launched a Phase IIa trial in
dialysis patients 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 the Israeli Ministry of Health of two Phase I/II
trials in Israel in hepatitis C, slated to commence Q3 2012; and
which 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
LHA Phone: +1 212-838-3777
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
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
This information is provided by RNS
The company news service from the London Stock Exchange
END
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