标题: [News] Medgenics PhaseI/II trials to access safety of INFRADURE [打印本页] 作者: 肝胆速递 时间: 2012-8-30 15:19 标题: [News] Medgenics PhaseI/II trials to access safety of INFRADURE
Medgenics (MDGN) 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.
Many Hepatitis C (HCV) players have experienced multiple failures with their drugs in clinical trials lately. The Biopump Platform technology provides sustained protein therapy for the treatment of various chronic diseases and conditions, including anemia, hepatitis, hemophilia, multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity, diabetes, and other chronic diseases or conditions -- without drugs. Medgenics might be in an excellent position now to grab future market share -- if its platform ultimately is approved by the FDA.
卫生部(MOH)以色列卫生部批准了两个I / II期临床试验,以评估安全性和有效性的INFRADURE患者丙型肝炎的一项研究将评估以前未经治疗的基因型1和3 Medgenics。(MDGN)宣布,其他研究基因1型患者以前治疗的最初回应后复发。