Medgenics Presents Expanded Results of Phase I/II Study of EPODURE Biopump for the Treatment of Anemia at the American Socie...
November 15 2011 - 9:00AM
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 that
positive data from a Phase I/II clinical trial of EPODURE to treat
anemia in chronic kidney disease patients was highlighted in a
poster presentation at the American Society of Nephrology’s Kidney
Week 2011, held November 8-13 in Philadelphia. The poster, titled
“Sustained Erythropoiesis 6-30 months by the EPODURE Biopump in
Patients with Chronic Kidney Disease: Further Results of Phase I/II
Proof of Concept Trial,” was presented November 11th by Dr. Allen
Nissenson of the David Geffen School of Medicine at UCLA.
The goal of this open-label, dose-ranging study
in anemic chronic kidney disease (CKD) patients was to demonstrate
EPODURE’s ability to provide more than six months of sustained
erythropoietin (EPO) delivery from a single treatment using
autologous 30mm x 2mm dermis core biopsies excised from the
patient’s skin under local anesthetic, and converted in days into
Biopump EPO production units by introducing the EPO genes into
cells of the intact explant. This poster reports the results in 13
patients (4 EPO-naïve, 9 EPO-dependent) treated 6-30 months with 20
or 40 IU/kg/day EPODURE implanted dose.
Key Study Findings
- The brief procedure was well tolerated
and there were no adverse events in any patients treated
- There were no anti-EPO antibody
formations and no serum EPO levels to date above 60 mU/ml
- EPODURE treatment elevated hemoglobin
levels and maintained >9 g/dl for >3 months in 12/13 patients
and >6 months in 7 /13 patients, with the longest >30
months
- EPODURE treatment maintained hemoglobin
between 10-12 g/dl in 10/13 patients for >3 months and 6/13
patients for >6 months, with the longest >30 months
Commenting on the results of the study, Dr.
Nissenson said, “Treatment with EPODURE was found to be safe and
doseable, with no antigenic response. We were pleased to have
demonstrated clinical feasibility showing that a single EPODURE
administration can raise and maintain hemoglobin levels for up to
30 months without any injections of erythropoietic stimulating
agents (ESAs). These data highlight EPODURE’s significant potential
to become an effective interventional treatment – a paradigm shift
in the way we treat anemic patients.”
According to Andrew L. Pearlman, President and
Chief Executive Officer of Medgenics, “We are very encouraged by
these positive data and look forward to advancing the clinical
development of EPODURE to treat anemia. Toward that end, we remain
on track to file an Investigation New Drug application with the
U.S. Food and Drug Administration for a Phase IIb clinical trial of
EPODURE by mid-2012. A safe, sustained delivery of EPO could reduce
the risks of hemoglobin variability while achieving the recommended
hemoglobin targets, thereby avoiding the supraphysiologic EPO
concentrations associated with the current injections of ESAs. It
also could significantly improve the logistics of anemia management
to the benefit of both patients and payors.”
To request a copy of the poster, please contact
Anne Marie Fields, Senior Vice President of LHA, at
afields@lhai.com.
About Kidney Week 2011
Kidney Week 2011 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 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 (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 (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 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.
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