MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the
developer of Biopump™, a novel technology for the sustained production
and delivery of therapeutic proteins in patients using their own tissue,
today announced that Israel's Ministry of Health (MOH) has approved two
Phase I/II clinical trials to assess the safety and efficacy of
INFRADURE™ in patients with hepatitis C. One study will evaluate
previously untreated patients with genotypes 1 and 3, and the other will
study genotype 1 patients who have relapsed after initially responding
to prior treatments.
These are the first approved clinical studies for the use of INFRADURE,
a subcutaneous autologous tissue implant developed to continuously
produce interferon alpha (IFNa). INFRADURE has been designed to be used
in treating hepatitis B, C, and D, as well as other diseases. The first
study will have up to 16 patients with hepatitis C and is expected to
start in the fourth quarter of 2012 and to last approximately 24 months.
The second study is planned to commence following initial results of the
first study.
The current standard of care for treating hepatitis C involves weekly
injections of pegylated IFNa, given in combination with the oral drug
ribavirin for all patients. In addition, genotype 1 patients receive a
protease inhibitor. These weekly injections can be associated with high
concentrations or spikes of IFNa and significant side effects, posing
considerable problems with patient compliance with a discontinuation
rate of 20-30%. These injections are the primary treatment for hepatitis
D and are often used in hepatitis B, where they pose similar problems.
INFRADURE aims to solve the problem of compliance and tolerability by
providing sustained levels of IFNa within the effective range for months
from a single treatment. A key aim of these studies is to show that
INFRADURE Biopumps can safely and continuously produce and deliver
effective levels of active IFNa into patients' circulation for a
sustained period of time. The studies have a simple cohort
dose-escalation design, which should help determine effective dosing of
INFRADURE to achieve suppression of the hepatitis C virus. These first
studies of INFRADURE in man, are intended to help develop and calibrate
the method for use in the different hepatitis indications.
Nezam H. Afdhal, M.D., Chief of Hepatology, Director of Liver Center,
Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard
School of Medicine and a member of Medgenics' Strategic Advisory Board,
stated, “This first INFRADURE study will be important not only for its
use in treating hepatitis C, but more broadly will calibrate use of this
novel method to offer continuous interferon therapy produced by the
patient's own tissue, for other forms of hepatitis such as B and D. The
immune system is the body's natural protection against viral infection
and is a key element of treatment for various forms of hepatitis.
INFRADURE aims to make the most of that natural defense by providing
sustained interferon to bolster the immune system while minimizing the
burdens of patient compliance and reducing side effects. INFRADURE
offers hope not only in hepatitis C, but could also fulfill an unmet
need for reliable interferon therapy for hepatitis D, an aggressive form
of hepatitis for which IFNa is the only effective treatment. It also
addresses the emerging need for a practical, time limited alternative to
years of expensive oral antiviral treatments for hepatitis B, a disease
which afflicts an estimated 350 million patients worldwide.”
Bruce R. Bacon, M.D., past President of the American Association for the
Study of Liver Disease, a recognized global expert in hepatitis and a
member of Medgenics' Strategic Advisory Board, commented, “Many have
been predicting that the use of interferon in treating hepatitis C will
be replaced by direct acting oral antiviral agents (DAAs), once these
show effectiveness and safety in widespread use. However, recent
developments in clinical studies suggest that safety may be an issue for
some DAAs and caution is recommended as we go forward in this arena.
INFRADURE potentially offers a safe alternative therapy for many of
these patients, and supplement to oral treatments in others.”
Hepatitis C is the third clinical indication for use of the Biopump
tissue-based protein production and delivery platform, to receive
clearance for clinical studies, with the first two being Chronic Kidney
Disease and End Stage Renal Disease. In addition, in June 2012 FDA
approved Orphan Drug Designation for INFRADURE for the treatment of
hepatitis D, using INFRADURE Biopumps in a manner similar to that in
hepatitis C patients. Worldwide, it is estimated there are 170 million
carriers of hepatitis C, with three to four million new infections
annually.
“Approval for clinical testing in a third indication underscores the
versatility of our Biopump platform,” stated Andrew L. Pearlman, Ph.D.,
President and Chief Executive Officer of Medgenics. “Following the
recent Orphan Drug Designation for INFRADURE in hepatitis D, these
hepatitis C clinical studies launch our broader hepatitis clinical
program. As the first clinical studies of INFRADURE, they will help us
develop its use in patients. We believe this not only holds promise for
the hepatitis C population, but perhaps even more importantly, will
advance the development of INFRADURE to meet the unmet needs in
hepatitis D and emerging needs hepatitis B – the largest hepatitis
patient population.”
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:
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EPODURE™ 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.
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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.
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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.
