TIDMMEDG TIDMMEDU
RNS Number : 0456L
Medgenics Inc
29 August 2012
Press Release 29 August 2012
Medgenics' Novel Tissue Implant Approved for Two Hepatitis C
Clinical Trials in Israel
First in man clinical trials of INFRADURE Biopumps for the
continuous production of interferon alpha from patient's own
tissue
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the
developer of Biopump(TM), 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(TM) 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(TM), 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(TM) 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 has received approval for 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(TM) for sustained production and delivery of
interferon-alpha for use in the treatment of hepatitis is awaiting
final approval of the Israeli Ministry of Health of two Phase I/II
trials in Israel in hepatitis C, slated to commence Q3 2012; and
which received Orphan Drug Designation from the FDA for the
treatment of hepatitis D.
-- HEMODURE(TM) 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 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.
For further information, contact:
Medgenics, Inc. Phone: +972 4 902 8900
Dr. Andrew L. Pearlman
Andrew.pearlman@medgenics.com
LHA Phone: 212-838-3777
Anne Marie Fields
afields@lhai.com
Abchurch Communications Phone: +44 207 398 7719
Adam Michael
Joanne Shears
Jamie Hooper
jamie.hooper@abchurch-group.com
Nomura Code Securities (NOMAD & Phone: +44 207 776 1200
Joint Broker)
Jonathan Senior / Giles Balleny
SVS Securities plc (Joint Broker) Phone: +44 207 638 5600
Alex Mattey
Ian Callaway
-Ends-
These approvals follow the Company's completed Phase I/II study
for the treatment of anemia in pre-dialysis patients, the clearance
by the U.S. Food and Drug Administration (FDA) of a Phase II study
for the treatment of anemia in dialysis patients, as well as an
ongoing clinical trial in the same indication in Israel.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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