Medgenics Announces Approval of Two Phase I/II Clinical Trials By Israel Regulator
Medgenics, (NYSE: MDGN), 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.
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