TIDMMEDG TIDMMEDU
RNS Number : 2169Q
Medgenics Inc
05 November 2012
Press Release 5 November 2012
Medgenics, Inc.
("Medgenics" or "the Company")
Medgenics Presents Preliminary Data from Phase IIa Study with
EPODURE to Treat Anemia in Dialysis Patients at Kidney Week
2012
Medgenics, Inc. (NYSE Amex: 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, announced the presentation of preliminary data
from its ongoing Phase IIa clinical trial in Israel with
EPODURE(TM) Biopumps to treat anemia in patients on dialysis with
end-stage renal disease ("ESRD"), by sustained delivery of
erythropoietin ("EPO"). Data from the first three patients were
highlighted in a poster presentation today at the American Society
of Nephrology's Kidney Week 2012, which is being held from October
30 through November 4 in San Diego. The poster is titled "Novel
Sustained Delivery of Erythropoietin in Hemodialysis Patients for
Safer Anemia Control using EPODURE(TM) Biopumps - Autologous Dermal
Tissue Samples Secreting Erythropoietin."
As the first study with EPODURE Biopumps in ESRD patients, the
Phase IIa study is testing administration techniques and dosing to
determine if EPODURE can replace most or all of the injections of
EPO or other erythropoietic stimulating agents ("ESAs") currently
used in the standard care of such patients, while maintaining blood
hemoglobin levels within the desired range. The current standard of
care involves frequent EPO or ESA injections, which require patient
compliance for reliable administration. Each injection is
short-lived, typically causing an extreme transient elevation of
EPO in the patient's blood, followed by a decline to ineffective
levels within a few days, so the patient may not have sufficient
EPO or ESA until the next injection. The high transient levels of
EPO in the blood are a source of potential safety concern to many
medical experts as well as to the U.S. Food and Drug Administration
("FDA").
Consistent with the earlier Phase I/II study with EPODURE in
pre-dialysis patients, the EPODURE procedure went well in these
first dialysis patients. These patients will continue to be
monitored and enrollment in the study is continuing.
Medgenics' EPODURE Biopumps aim to provide a cost-effective way
to maintain hemoglobin within a target physiological range for
anemic patients through the sustained delivery of EPO, while
avoiding the extreme elevations seen with injections. 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, and also
provides significant cost benefits to payers.
"We believe that this Phase IIa study will provide valuable
insight into the use of EPODURE to treat anemia in patients on
dialysis, which is the largest segment of the anemia market.
Although the findings presented at Kidney Week 2012 are on only
three patients, we are thus far encouraged by this ongoing study.
Full study results can be supportive of the larger Phase II study
in dialysis patients in the U.S., now slated to begin in the first
half of 2013. Once completed, we believe 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 Kidney Week 2012
Kidney Week 2012 is the world's premier nephrology meeting. More
than 13,000 kidney professionals from around the globe come
together to exchange knowledge, learn the latest scientific and
medical advances, and listen to engaging and provocative exchanges
between leading experts in the field.
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 is currently in a Phase IIa trial
in dialysis 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, which has
received approval for two Phase I/II trials in in hepatitis C from
the Israeli Ministry of Health with the first slated to commence in
Q4 2012; and has 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
Abchurch Communications Phone: +44 207 398 7718
Adam Michael
Joanne Shears
Harriet Rae
harriet.rae@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
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
END
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