Bayer发起两次帕金森试验:第三阶段的干细胞治疗,第二阶段的基因治疗。
Bayer launches two Parkinson’s trials: stem cell therapy in Phase III, gene therapy in Phase II.
Bayer已开始对帕金森病进行两次新的临床试验,推动与BlueRock治疗和AskBio子公司开发的调查疗法。
Bayer has initiated two new clinical trials for Parkinson’s disease, advancing investigational therapies developed with subsidiaries BlueRock Therapeutics and AskBio.
第三阶段前PDite-2试验开始用Bemdaneprocel治疗病人,Bemdaneprocel是一种干细胞衍生疗法,旨在取代丧失的多巴胺生成神经元,在第一阶段取得积极结果后,显示出良好的耐受性和早期运动改进。
The Phase III exPDite-2 trial began treating patients with bemdaneprocel, a stem cell-derived therapy aimed at replacing lost dopamine-producing neurons, following positive Phase I results showing good tolerability and early motor improvements.
同时,第二阶段的REGENERATE-PD试验开始招收AB-1005的参与者,这是一种针对中阶段帕金森人的基因疗法。
Simultaneously, the Phase II REGENERATE-PD trial started enrolling participants for AB-1005, a gene therapy targeting moderate-stage Parkinson’s.
这两种疗法都仍在调查之中,未获批准,目的是改善运动和非运动症状。
Both therapies are still under investigation, not approved, and aim to improve motor and non-motor symptoms.
贝马丹尼已获得FDA快速跟踪和RMAT指标.
Bemdaneprocel has received FDA Fast Track and RMAT designations.
这些试验的结果可能为今后提交管制文件提供依据,但治疗方法仍然是实验性的,无法供临床使用。
Results from these trials may inform future regulatory submissions, but the treatments remain experimental and unavailable for clinical use.