German pharmaceutical and life sciences major Bayer AG (BAYZF.PK,BAYRY.PK,BYR.L) announced Thursday that its clinical stage cell therapy unit BlueRock Therapeutics LP's investigational cell therapy bemdaneprocel to treat Parkinson's disease has received the U.S. Food and Drug Administration's Regenerative Medicine Advanced Therapy or RMAT designation.Bemdaneprocel (BRT-DA01) is designed to replace the dopamine producing neurons that are lost in Parkinson's disease, a progressive neurodegenerative disorder caused by the death of nerve cells in the brain.

德国制药和生命科学专业拜耳公司（BAYZF.PK，BAYRY.PK，BYR.L）周四宣布，其临床阶段细胞治疗部门BlueRock Therapeutics LP的用于治疗帕金森氏病的研究性细胞疗法bemdaneprocel已获得美国食品和药物管理局的再生医学高级疗法或RMAT指定。Bemdaneprocel（BRT-DA01）被设计用来替代帕金森病（Parkinson's disease）中丢失的产生多巴胺的神经元，帕金森病是一种由大脑神经细胞死亡引起的进行性神经退行性疾病。

In a surgical procedure, neuron precursors are implanted into the brain of a person with Parkinson's disease. BlueRock's RMAT designation follows phase I clinical trial results announced in March demonstrating that bemdaneprocel is well tolerated with no major safety issues through 18 months. In addition, an observed increase in the F-DOPA PET imaging signal after stopping immune suppression therapy at 12 months demonstrates that the transplanted cells survive and engraft in the brain.The company noted that Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S.

在外科手术中，神经元前体被植入帕金森病患者的大脑中。BlueRock的RMAT指定是在3月份宣布的I期临床试验结果之后，该试验结果表明，bemdaneprocel在18个月内耐受性良好，没有重大安全问题。此外，在12个月时停止免疫抑制治疗后，观察到F-DOPA PET成像信号的增加表明移植的细胞存活并植入大脑。该公司指出，Bemdaneprocel是美国临床上最先进的研究性细胞疗法。

for treating patients living with Parkinson's disease.The RMAT program, managed by the FDA's Center for Biologics, Evaluation and Research, focuses on investigational regenerative medicines, including cell therapies, intended to treat, modify, reverse, or cure serious diseases..

用于治疗帕金森病患者。由FDA生物制剂，评估和研究中心管理的RMAT计划专注于研究性再生药物，包括细胞疗法，旨在治疗，改变，逆转或治愈严重疾病。。

Christian Rommel, Head of Research and Development at Bayer's Pharmaceuticals Division, said, 'The RMAT designation for bemdaneprocel underscores the potential of this candidate to fundamentally change the way we think about Parkinson's disease care. We are driven by our commitment to deliver breakthrough innovation for patients and are proud and excited to see bemdaneprocel continuing to clear hurdles in the development process.'Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.For More Such Health News, visit rttnews.com For comments and feedback contact: editorial@rttnews.comBusiness News.

拜耳制药部研发负责人克里斯蒂安·隆美尔（ChristianRommel）表示，“贝姆丹普罗塞尔（bemdaneprocel）的RMAT名称突显了这位候选人从根本上改变我们对帕金森病护理的看法的潜力。我们致力于为患者提供突破性创新，我们对此感到骄傲和兴奋，看到bemdaneprocel继续在开发过程中扫清障碍。”Bemdaneprocel尚未被任何卫生部门批准用于治疗任何疾病或医疗状况。有关更多此类健康新闻，请访问rttnews.com获取评论和反馈联系方式：editorial@rttnews.comBusiness新闻。