First cohort of REGALS (T Regulatory Cells for ALS) has been completed.

第一批REGALS（ALS的T调节细胞）已经完成。

Ongoing Phase 1/1b study evaluating safety and efficacy of CK0803 (Neurotrophic T regulatory cells).

正在进行的1/1b期研究评估了CK0803（神经营养性T调节细胞）的安全性和有效性。

HOUSTON, Jan. 19, 2024 /PRNewswire/ -- Michael E. DeBakey VA Medical Center announces opening of a new clinical trial using CK0803- off-the-shelf, allogeneic T regulatory cells that have been modified to target neuroinflammation to treat the fatal neurodegenerative disease – Amyotrophic Lateral Sclerosis (ALS)..

休斯顿，2024年1月19日/PRNewswire/--迈克尔·E·德巴基弗吉尼亚州医学中心宣布开始一项新的临床试验，该试验使用CK0803-现成的同种异体T调节细胞，该细胞已被修饰为靶向神经炎症，以治疗致命的神经退行性疾病-肌萎缩侧索硬化症（ALS）。。

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ALS Clinical Coordinator Richel Aliboso, NP, Principal Investigator Dr. James Orengo and Study Coordinator Michelle Espiritu are thrilled to enroll Houston VA Veterans into this groundbreaking clinical trial.

ALS临床协调员Richel Aliboso，NP，首席研究员James Orengo博士和研究协调员Michelle Espiritu很高兴能招募休斯顿退伍军人参加这项开创性的临床试验。

'We are very excited to open this first-in-class, best-in-class, cell therapy aimed to resolve neuroinflammation which fuels the ALS disease process. We believe that this novel approach of calming the inflamed microglia in the brain and spinal cord holds the promise for halting this relentlessly progressing disease', said Dr.

“我们非常兴奋能够推出这一一流、一流的细胞疗法，旨在解决加剧ALS疾病过程的神经炎症。我们相信，这种平息大脑和脊髓发炎的小胶质细胞的新方法有望阻止这种不断发展的疾病”。

James Orengo, principal investigator at the Michael E. DeBakey VA Medical Center and Assistant Professor of Neurology at Baylor College of Medicine. 'Specifically, we are thrilled that our veterans will get the opportunity to receive such a cutting edge therapeutic that could be life altering. The incidence of ALS is elevated in Veterans and novel therapies are desperately needed.

詹姆斯·奥伦戈是弗吉尼亚州迈克尔·德巴基医学中心的首席研究员，贝勒医学院神经病学助理教授具体来说，我们很高兴我们的退伍军人将有机会接受这种可能改变生活的尖端治疗。退伍军人的ALS发病率升高，迫切需要新的治疗方法。

We are proud to be the first and only VA hospital in the nation to be part of this multi-center study'. Please click here for the VA announcement..

我们很自豪成为国内第一家也是唯一一家参与这项多中心研究的VA医院”。请单击此处获取VA公告。。

ALS is a rare, rapidly progressing and fatal neurodegenerative disorder that affects approximately 55,000 people globally. People with ALS experience muscle weakness, loss of movement, and difficulty breathing and swallowing, resulting in a severely declining quality of life and eventually death. The incidence of ALS has been rising in the veteran population and is a large unmet need.

ALS是一种罕见的，进展迅速且致命的神经退行性疾病，影响全球约55000人。ALS患者会出现肌肉无力，运动障碍，呼吸和吞咽困难，导致生活质量严重下降，最终死亡。退伍军人中ALS的发病率一直在上升，这是一个巨大的未满足需求。

More than 16% of patients with ALS are veterans1. There are many health issues that veterans are at increased risk of, including ALS2. Veterans are twice as likely to be diagnosed with ALS than people who haven't served in the military3. .

超过16%的ALS患者是退伍军人1。退伍军人面临许多健康问题的风险增加，包括ALS2。退伍军人被诊断出患有ALS的可能性是没有在军队服役的人的两倍3。

'There is an urgent need for novel treatments for all forms of ALS, a devastating disease that affects far too many patients and their families. We made a conscious decision to make this novel cell therapy available to the veterans and remain committed to provide our continued support to those who have served our country,' said Tara Sadeghi, Cellenkos' chief operating officer.

“迫切需要对所有形式的ALS进行新的治疗，ALS是一种破坏性疾病，影响了太多的患者及其家人。Cellenkos首席运营官塔拉·萨德吉（TaraSadeghi）说，我们有意识地决定向退伍军人提供这种新型细胞疗法，并继续致力于为那些为国家服务的人提供持续的支持。

'Leveraging our experience in consistently developing and manufacturing, robust, T regulatory cell therapies that are targeted towards disease specific mechanism of action and our intimate connection to the ALS patient community, Cellenkos made the decision to advance CK0803 to the clinic and, ultimately, to the market because we believe we are uniquely positioned to make it available to patients living with ALS.'The first cohort of phase 1/ 1b CK0803 trial has been completed and is currently open for enrollment at Columbia University, New York, NY, led by PI, Dr Neil Shneider, M.D., Ph.D., director of Columbia University's Eleanor and Lou Gehrig ALS Center.About Amyotrophic Lateral Sclerosis (ALS)According to the National Institute of Neurological Disorders and Stroke, amyotrophic lateral sclerosis (ALS) is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement.

“Cellenkos利用我们在不断开发和制造针对疾病特异性作用机制的强大T调节细胞疗法方面的经验，以及我们与ALS患者社区的密切联系，决定将CK0803推向临床，并最终，因为我们相信我们拥有独特的地位，可以为ALS患者提供服务。”第一组1/1b期CK0803试验已经完成，目前正在纽约哥伦比亚大学注册，由PI，Neil Shneider博士，医学博士，博士，哥伦比亚大学埃莉诺主任和Lou Gehrig ALS中心领导。关于肌萎缩侧索硬化症（ALS）根据美国国家神经疾病和中风研究所的说法，肌萎缩侧索硬化症（ALS）是一组罕见的神经系统疾病，主要涉及负责控制自主肌肉运动的神经细胞（神经元）。

In ALS, both the upper motor neurons and the lower motor neurons degenerate or die and stop sending messages to the muscles. Unable to function, the muscles gradually weaken and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. The disease is progressive, meaning the symptoms get worse over time.

在ALS中，上运动神经元和下运动神经元都退化或死亡，并停止向肌肉发送信息。由于无法发挥功能，肌肉逐渐衰弱并消失（萎缩）。最终，大脑失去了启动和控制自主运动的能力。这种疾病是进行性的，意味着症状会随着时间的推移而恶化。

The majority of ALS cases (90 percent or more) are considered sporadic. This means the disease seems to oc.

大多数ALS病例（90%或更多）被认为是零星的。这意味着这种疾病似乎是oc。

1 https://vamboa.org/more-than-sixteen-percent-of-als-patients-are-military-veterans/. 2 https://iamals.org/get-help/understanding-veterans-risk-for-als/ 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756624/

1个https://vamboa.org/more-than-sixteen-percent-of-als-patients-are-military-veterans/.2https://iamals.org/get-help/understanding-veterans-risk-for-als/3https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756624/

Contact: Stacy Minor[email protected].SOURCE Cellenkos, Inc.

联系人：Stacy Minor[受电子邮件保护]。来源Cellenkos，Inc。