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."