First U.S. Multi-center, Multi-patient Phase 1/2a Trial of an Autologous Neurological Therapy SAN DIEGO, April 17, 2024 /PRNewswire/ -- Aspen Neuroscience, Inc. announced that the first patient has been dosed in the ASPIRO trial, a Phase 1/2a open label clinical trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe Parkinson's disease (PD).

2024年4月17日，圣地亚哥，美国第一个自体神经治疗的多中心，多患者1/2a期临床试验/PRNewswire/--Aspen Neuroscience，Inc.宣布，第一名患者已在ASPIRO试验中服用，ASPIRO试验是一项1/2a期开放标签临床试验，用于评估ANPD001的安全性和耐受性，ANPD001是一种针对中重度帕金森病（PD）参与者的自体多巴胺能神经元细胞替代疗法。

Aspen Neuroscience is a private biotechnology company developing personalized regenerative therapies..

Aspen Neuroscience是一家私人生物技术公司，开发个性化再生疗法。

The first transplantation procedure in the ASPIRO study was performed by Banner – University Medical Center Tucson neurosurgeon Paul Larson, MD, FAANS, professor of neurosurgery at the University of Arizona College of Medicine – Tucson. The hospital is one of five clinical sites for the Phase 1/2a trial.  Dr.

ASPIRO研究中的第一个移植手术是由Banner大学医学中心图森神经外科医生Paul Larson进行的，Paul Larson医学博士，FAANS，亚利桑那大学图森医学院神经外科教授。该医院是1/2a期试验的五个临床地点之一。博士。

Larson is the lead neurosurgeon and Banner – University Medicine Tucson is the lead dosing site for the ASPIRO study..

拉森是首席神经外科医生，班纳-图森大学医学院是ASPIRO研究的主要给药地点。

Aspen Neuroscience Launches Groundbreaking Clinical Trial in Parkinson's Disease

Aspen Neuroscience启动帕金森病开创性临床试验

Dr. Larson is a pioneer in the field of interventional MRI-guided stereotaxy, and has performed over 1,000 iMRI procedures. His clinical research team has been the solo or lead group in 12 cell and gene therapy clinical research trials since 2004, and is one of the top teams in intracranial delivery of novel therapeutics for neurodegenerative disorders. .

Larson博士是介入MRI引导立体定向领域的先驱，并进行了1000多次iMRI手术。自2004年以来，他的临床研究团队一直是12项细胞和基因治疗临床研究试验的单独或领导小组，并且是颅内神经退行性疾病新疗法的顶级团队之一。。

'Parkinson's disease is the most common neurodegenerative movement disorder, primarily affecting the depletion of dopamine neurons in the midbrain.  By the time of diagnosis, it is common for people with Parkinson's to have lost the majority of dopaminergic (DA) neurons in the nigrostriatal pathway, which leads to progressive loss of motor and neurological function,' explained Dr.

帕金森氏病是最常见的神经退行性运动障碍，主要影响中脑多巴胺神经元的消耗。到确诊时，帕金森病患者在黑质纹状体通路中失去了大部分多巴胺能（DA）神经元是很常见的，这会导致运动和神经功能的逐渐丧失。

Larson. 'This is the first use of the autologous approach in a formal clinical trial, and it is an honor to be part of this important study.''The initiation of this clinical trial is a major milestone in Aspen's mission to develop and deliver personalized, regenerative neurologic therapies for people with unmet medical needs, starting with Parkinson's disease,' said Damien McDevitt, PhD, Aspen Neuroscience President and Chief Executive Officer.

拉尔森。”这是自体方法在正式临床试验中的首次使用，很荣幸成为这项重要研究的一部分Aspen Neuroscience总裁兼首席执行官达米恩·麦克德维特（DamienMcDevitt）博士说，这项临床试验的启动是Aspen为帕金森氏病患者开发和提供个性化再生神经疗法的使命的一个重要里程碑。

'To date, there is no disease-modifying therapy that can stop, replace or prevent the loss of dopamine neurons or slow the progression of Parkinson's.''This first-in-human trial holds significant promise to investigate the ability of ANPD001 to improve the lives of people with moderate to advanced Parkinson's disease,' said Edward Wirth III, MD, PhD, Chief Medical Officer of Aspen Neuroscience.  'Our 2022 Trial Ready Cohort Screening Study has completed enrollment, and we plan to dose patients in the ASPIRO Phase 1/2a study this year.'About the ASPIRO TrialASPIRO is an open-label Phase 1/2a clinical trial to assess the safety and tolerability of ANPD001 in patients with moderate to severe Parkinson's disease. The trial includes patients 50–70 years of age, and excludes patients with cognitive impairment and other comorbidities that could preclude treatment.

Aspen Neuroscience首席医学官爱德华·沃思（EdwardWirth III）医学博士说：“迄今为止，还没有一种能够阻止、替代或预防多巴胺神经元丢失或减缓帕金森病进展的疾病缓解疗法。”“这项首次人体试验有望研究ANPD001改善中晚期帕金森病患者生活的能力。”。“我们的2022年试验就绪队列筛查研究已经完成登记，我们计划今年在ASPIRO 1/2a期研究中为患者提供剂量。”关于ASPIRO TrialASPIRO是一项开放标签的1/2a期临床试验，用于评估ANPD001在中重度帕金森病患者中的安全性和耐受性。该试验包括50-70岁的患者，不包括认知障碍和其他可能妨碍治疗的合并症患者。

All enrolled patients are under the care of a movement disorder specialist.The primary study endp.

所有登记的患者都由运动障碍专家照顾。主要研究结束。