Medgenics' Infradure in first clinical trial for hepatitis

Source：Medgenics, Inc. Release Date：2013-02-01 172

Medical Equipment

Phase I/II study in hepatitis C expected to provide gateway to hepatitis B and D

MISGAV, Israel & SAN FRANCISCO -- Medgenics, Inc. has enrolled the first patient in a Phase I/II clinical trial for its 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 the tissue treatment 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 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.Air Max Hyperposite