Medgenics Provides Clinical and Regulatory Update
November 09 2011 - 9:06AM
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 provided a clinical update
on the Company’s progress with the development of its Biopump which
is being developed for the treatment of a range of chronic diseases
including anemia and hepatitis C.
Discussing the Company’s clinical progress, Andrew L. Pearlman,
Ph.D., President and Chief Executive Officer of Medgenics, said,
“We have continued to make important advances with the clinical
development of the Biopump in a number of indications. We held a
positive and productive meeting with the U.S. Food and Drug
Administration (“FDA”) to discuss our proposed protocol for a Phase
IIb clinical trial of EPODURE to treat anemia in patients with
renal failure, and the route to regulatory approval for EPODURE in
the U.S. We were pleased and encouraged by our dialogue with the
FDA and appear to be well on track with our plans to file an
Investigational New Drug (“IND”) application for the Phase IIb
study in mid-2012.
“We look forward to the presentation of the updated results of
our Phase I/II dose-ranging trial of EPODURE to treat anemia in
pre-dialysis, chronic kidney disease patients in a poster
presentation on November 11th at the American Society of
Nephrologists by Dr. Allen Nissenson of the David Geffen School of
Medicine at UCLA. The study has demonstrated sustained elevation
and stabilization of hemoglobin levels in anemic patients, with
most remaining non-anemic without the need for injections of
erythropoietic stimulating agents (“ESAs”) for six to more than 30
months from a single administration of EPODURE Biopumps, without
any reported adverse events. We view this as particularly
remarkable given that in this dose ranging study patients were
restricted to treatment with a single, fixed dose that was not
tailored to the patient’s needs or adjusted to optimize response to
treatment. In addition, we have obtained Investigational Review
Board (“IRB”) approval from Tel Aviv Medical Center in Israel for a
Phase II clinical trial of EPODURE to treat anemia patients on
kidney dialysis and are awaiting final approval from the Israeli
Ministry of Health, which we expect to be cleared to initiate
during the first quarter of 2012. This will be our first trial in
dialysis patients and the first in which we will be able to adjust
the dose to meet patients’ needs.
“We have also made substantial strides towards the approval and
launch of our first studies of Biopumps in the treatment of
hepatitis C. We submitted protocols and have obtained IRB approval
from Hadassah Medical Organization and Tel Aviv Medical Center in
Israel, for two Phase I/II clinical studies using INFRADURE to
demonstrate continuous production and delivery of interferon-alpha
for the treatment of patients with hepatitis C. These protocols are
now under review by the Israeli Ministry of Health, and we expect
to be cleared to initiate these trials in the first half of
2012.
“Moving forward, we are very excited about the opportunities for
Medgenics’ Biopump in a variety of therapeutic indications and look
forward to continuing to advance our technology both through
internal development and through collaborations,” noted Dr.
Pearlman.
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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