Medgenics, Inc., a developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, has enrolled its first patient in 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 Centre 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 per cent. 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.

IInfradure 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.

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 US. Hepatitis D, an aggressive form of hepatitis, affects approximately 15-20 million people worldwide, and is estimated to afflict tens of thousands in the US. Hepatitis C affects an estimated 180 million people worldwide and over three million in the US.

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 anaemia, hepatitis and haemophilia, among others.