Medgenics Receives FDA Clearance to Commence Phase IIb Trial of EPODURE for Sustained Anemia Treatment in Dialysis Patients
May 17 2012 - 10:00AM
Business Wire
Medgenics, Inc. (NYSE MKT: MDGN)(AIM: MEDU)(AIM: MEDG) (the
“Company”), developer of the novel Biopump™ technology for the
sustained production and delivery of therapeutic proteins in
patients using their own tissue, today announced receipt of
clearance from the U.S. Food and Drug Administration (“FDA” or the
“Agency”) to proceed with a Phase IIb clinical trial of EPODURE™
for the treatment of anemia in patients undergoing renal dialysis.
EPODURE is intended to produce and deliver erythropoietin (“EPO”)
on a sustained basis. This multi-center, randomized clinical trial
will be the first study in the U.S. using the Company’s proprietary
Biopump™ technology, and will evaluate the safety and efficacy of
sustained EPO therapy delivered via Medgenics' EPODURE Biopump.
Treatment of anemia in dialysis patients with EPODURE is intended
to replace frequent injections of EPO or other erythropoietic
stimulating agents (“ESAs”).
“This timely acceptance of our first Investigational New Drug
(“IND”) to the FDA marks a significant milestone for our Biopump
protein platform. We are very pleased with our U.S. regulatory
progress and with the interactions with the FDA, allowing us to
proceed with the launch of our first U.S. trial,” stated Andrew L.
Pearlman, Ph.D., Chief Executive Officer of Medgenics. “This trial
is significant for Medgenics as a company as well as for patients
with anemia, as we anticipate EPODURE could provide a better
treatment for anemia in the future.”
“We are hopeful that the positive interaction with the FDA for
EPODURE bodes well for the Agency’s approach to other future
indications for our Biopump protein delivery platform technology,”
added Dr. Pearlman.
The FDA cleared the Phase IIb study protocol based on results
from the Company’s prior Phase I/II anemia study of EPODURE in
Israel, which reported safety and maintenance of hemoglobin for
months from a single EPODURE treatment in pre-dialysis patients
without requiring injections of EPO or ESAs, as well as on the
complete preclinical package. The Company was particularly
encouraged that clearance was received within the 30-day required
regulatory response period from submission of the IND application
and without major issues being raised. Medgenics views this as an
early, second validation from an independent critical review in the
U.S. of its Biopump platform. The Company announced in March that
the National Institutes of Health’s Recombinant DNA Advisory
Committee had given positive responses to the Company’s prior
scientific and clinical data and its proposed Phase IIb study
protocol.
The Company believes EPODURE has the potential to revolutionize
the treatment of anemia by stabilizing hemoglobin levels within a
safe range. This approach is designed to keep serum EPO levels
within their normal physiological range and avoid excessive levels
resulting from bolus EPO injections. This could be important in
improving safety and addressing market concerns about the effects
of excessive levels of EPO used in the treatment of anemia.
About MedgenicsMedgenics 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 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 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 in a Phase I/II
dose-ranging trial, and has received approval of a Phase IIa trial
in dialysis patients due to launch in Q2 2012 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
is awaiting final approval of two Phase I/II trials in Israel in
hepatitis C, slated to commence in Q3 2012, and is filed for Orphan
Drug Designation with the FDA to treat hepatitis D.
- HEMODURE™ 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 StatementsThis 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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