Medgenics Launches First Clinical Trial in Hepatitis to Use INFRADURE Tissue Treatment
January 30 2013 - 6:00AM
Business Wire
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the
“Company”), the developer of a novel platform technology for the
sustained production and delivery of therapeutic proteins in
patients using their own tissue, announced today that the first
patient has been enrolled in a Phase I/II clinical trial with the
Company’s INFRADURE™ Biopump™ for the treatment of hepatitis C.
This is the first clinical trial of INFRADURE, a subcutaneous
autologous skin tissue implant for the continuous production and
delivery of interferon-alpha (INFa) being developed by Medgenics to
treat hepatitis B, C and D, aimed at replacing months of weekly
injections of INFa, along with their serious side effects.
The Phase I/II dose-escalation study is being initiated at the
Tel Aviv Sourasky Medical Center in Israel, with additional sites
in Israel expected to join the study. The study is enrolling
patients with hepatitis C of genotypes 2 and 3, who would normally
receive weekly injections of pegylated INFa together with a daily
dose of the oral antiviral drug ribavirin These patients will
receive a single implantation of INFRADURE Biopumps in place of the
weekly injections, together with daily ribavirin. The study is
designed to show safety and tolerability of INFRADURE through the
continuous delivery of INFa into the patient’s circulation and to
determine effective dose levels that suppress serum levels of
hepatitis C virus. Medgenics believes that the results of this
study will assist in developing and calibrating INFRADURE for use
in additional types of viral hepatitis, as well as other
indications.
INFRADURE is aimed at replacing injections of INFa to address a
global market of over 500 million patients suffering from various
forms of hepatitis. This proof of concept study will test
INFRADURE’s approach of continuous production of INFa from the
patient’s own dermal tissue. The INFRADURE treatment will be
similar whether used in hepatitis C, hepatitis B, the most
widespread form of hepatitis, or hepatitis D, a rare and highly
aggressive form of the viral disease.
The current standard of care for treating hepatitis C involves
weekly injections of pegylated INFa plus daily ribavirin. These
weekly injections can be associated with high concentrations or
spikes of INFa in patients, as well as significant side effects.
These side effects pose considerable problems with patient
compliance, as reflected in a therapy discontinuation rate of over
25%. INFa injections are also the primary treatment for hepatitis D
and are often used in hepatitis B, where they pose similar
problems. INFRADURE aims to address compliance and tolerability by
providing sustained levels of INFa within the effective range for a
sustained period from a single treatment, while avoiding high
concentrations that are seen immediately following injections.
INFRADURE is the second product based on the Company’s Biopump
tissue-based platform to reach clinical trials in patients.
INFRADURE employs the same approach as the Company’s EPODURE™
implant producing erythropoietin, which reported months of safe and
sustained treatment of anemia from a single treatment in a Phase
I/II study in patients with chronic kidney disease, replacing
frequent erythropoietin injections.
About Hepatitis
Hepatitis is an inflammation of the liver and refers to a group
of viral infections that affect that organ. The most common types
are hepatitis A, hepatitis B and hepatitis C. Viral hepatitis is
the leading cause of liver cancer and the most common reason for
liver transplantation. Hepatitis B affects more than 350 million
people worldwide and approximately 1.3 million in the U.S.
Hepatitis D, an aggressive form of hepatitis, affects approximately
15-20 million people worldwide, and is estimated to afflict tens of
thousands in the U.S. Hepatitis C affects an estimated 180 million
people worldwide and over 3 million in the U.S.
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. For more
information, visit the Company’s website at www.medgenics.com.
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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