Medgenics Announces EPODURE to be Presented in Poster Session at the American Society of Nephrology’s Kidney Week 2012
October 23 2012 - 8:30AM
Business Wire
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG)
(the “Company”), the developer of a novel technology for the
sustained production and delivery of therapeutic proteins in
patients using their own tissue, today announced the Company will
be presenting a poster at the upcoming American Society of
Nephrology’s Kidney Week 2012, taking place from October 30 to
November 4 in San Diego.
The poster, titled “Novel Sustained Delivery of Erythropoietin
in Hemodialysis Patients for Safer Anemia Control using EPODURE™
Biopumps – Autologous Dermal Tissue Samples Secreting
Erythropoietin,” presents preliminary data from a Phase IIa
clinical trial of EPODURE to treat anemia patients with end stage
renal disease (ESRD).
EPODURE is an autologous dermal Biopump capable of the sustained
secretion of therapeutic erythropoietin (“EPO”) in the body using a
small tissue explant from the patient’s own skin and processed to
continuously produce EPO for many months. The EPODURE Biopump is
subsequently implanted subcutaneously into the patient to provide
continuous delivery of EPO.
Posters will be showcased in Poster Reception Halls A - C from
November 1-3 and will be available for viewing on those days from
9:30 a.m. to 2:30 p.m. with presentations taking place from 10:00
a.m. to 12:00 p.m. Medgenics’ poster will be presented at Kidney
Week 2012 on Friday, November 2nd.
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™, a
proprietary tissue-based platform technology for the sustained
production and delivery of therapeutic proteins using the patient's
own tissue 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™ to produce and deliver
erythropoietin 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™ 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 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™ for sustained production and
delivery of clotting Factor VIII therapy for the sustained
prophylactic treatment of hemophilia, which 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.
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