Berlin, Germany and Cambridge, MA USA, March 6, 2024 – Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today details of 18-month data from the phase I clinical trial for bemdaneprocel, an investigational allogeneic stem cell derived cell therapy for treating Parkinson’s disease.

德国柏林和美国马萨诸塞州剑桥，2024年3月6日–拜耳公司和BlueRock Therapeutics LP，一家临床阶段细胞治疗公司，拜耳公司全资独立运营的子公司，今天宣布了贝姆达尼普赛尔I期临床试验18个月数据的详细信息，贝姆达尼普赛尔是一种用于治疗帕金森病的研究性异基因干细胞衍生细胞疗法。

The data were presented at the Alzheimer’s and Parkinson’s Diseases Conference in Lisbon, Portugal.The data demonstrate that at 18 months bemdaneprocel continues to be well tolerated with no major safety issues, transplanted cells survive and engraft in the brain and F-DOPA signal continues to increase after stopping immune suppression therapy at 12 months as outlined in the study’s protocol.In addition, exploratory clinical endpoints improved compared to baseline assessments in both cohorts, with participants in the high dose cohort showing greater improvement than those in the low dose cohort.

这些数据在葡萄牙里斯本举行的阿尔茨海默病和帕金森病会议上公布。数据表明，在18个月时，bemdaneprocel的耐受性仍然很好，没有重大安全问题，移植的细胞存活并植入大脑，并且如研究方案所述，在12个月停止免疫抑制治疗后，F-DOPA信号继续增加。此外，与两个队列的基线评估相比，探索性临床终点有所改善，高剂量队列的参与者比低剂量队列的参与者表现出更大的改善。

These were assessed by the MDS-Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) and the Hauser Diary, which are tools used to assess Parkinson’s disease severity in motor symptoms.“It’s exciting that bemdaneprocel met safety and tolerability criteria at 12 months, and now the 18-month results suggest that these allogeneic cells survive and have potentially positive effects even after discontinuation of immunosuppressants,” said Claire Henchcliffe, MD, chair of the UCI School of Medicine Department of Neurology at the University of California, Irvine and one of the study’s Principal Investigators.

这些由MDS统一帕金森病评定量表第三部分（MDS-UPDRS第三部分）和豪泽日记（Hauser日记）进行评估，这是用于评估帕金森病运动症状严重程度的工具。加州大学UCI医学院神经病学系主任Claire Henchcliffe医学博士说：“令人兴奋的是，bemdaneprocel在12个月时达到了安全性和耐受性标准，现在18个月的结果表明，这些同种异体细胞即使在停用免疫抑制剂后仍能存活并具有潜在的积极作用。”，欧文和该研究的主要调查人员之一。

“We should not overinterpret results of a phase I study, but this is a promising step that deserves to be followed up with further studies.”Using the Hauser Diary, which categorizes patien.

“我们不应该过度解释I期研究的结果，但这是一个有希望的步骤，值得进一步研究。”使用Hauser日记对患者进行分类。