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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。
这是第一个被批准临床研究的INFRADURE的使用,皮下植入自体组织不断产生干扰素α(IFNA)。 INFRADURE已被设计为用于治疗B型肝炎,C,和D,以及其他疾病。第一项研究中,将有多达16丙型肝炎患者,并预计在2012年第四季度开始,持续约24个月。第二项研究计划开始的第一项研究的初步结果。
许多丙型肝炎病毒(HCV)最近球员都经历过多次失败,他们在临床试验中的药物。的Biopump平台技术用于治疗各种慢性疾病和条件,包括贫血,肝炎,血友病,多发性硬化症,关节炎,儿童生长激素缺乏症,肥胖症,糖尿病,及其他慢性疾病或条件 - 不沾染毒品的情况下提供持续的蛋白治疗。 Medgenics可能是在一个很好的位置,以抢占未来的市场份额 - 如果它的平台最终被美国FDA批准。
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