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.