On January
30, 2013, Medgenics, Inc. (the “Company” or “Medgenics”) announced 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.
Forward-looking Statements
This Form 8-K 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 Form 8-K may not occur.