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Luxa Biotechnology获得400万美元CIRM拨款,支持成人RPESC-RPE-4W治疗干性年龄相关黄斑变性的临床试验

Luxa Biotechnology Awarded $4 Million CIRM Grant to Support Clinical Trial of Adult RPESC-RPE-4W Therapy for Dry Age-related Macular Degeneration

businesswire 等信源发布 2024-05-01 17:00

可切换为仅中文


FORT LEE, N.J.--(BUSINESS WIRE)--Luxa Biotechnology (LuxaBio), a joint venture between Y2 Solution Co. Ltd, Seoul, South Korea and the Neural Stem Cell Institute (NSCI) in Rensselaer, New York, today announced receipt of a $4 million grant from the California Institute for Regeneration Medicine (CIRM) to support the ongoing Phase 1/2a study (NCT04627428) of RPESC-RPE-4W transplantation for the treatment of dry age-related macular degeneration (dry AMD).

新泽西州李堡(商业新闻短讯)--Luxa Biotechnology(LuxaBio)是韩国首尔Y2 Solution Co.Ltd与纽约伦斯勒尔神经干细胞研究所(NSCI)的合资企业,今天宣布收到加利福尼亚再生医学研究所(CIRM)400万美元的赠款,以支持正在进行的RPESC-RPE-4W移植治疗干性年龄相关性黄斑变性(干性AMD)的1/2a期研究(NCT04627428)。

The funding will accelerate manufacturing and clinical activities based in California..

这笔资金将加速加利福尼亚州的制造和临床活动。。

RPESC-RPE-4W is a cell product derived from adult retinal pigment epithelial stem cells (RPESC) that generate retinal pigmented epithelium (RPE) cell progeny (RPESC-RPE). Transplantation of progenitor-stage RPESC-RPE cells obtained after four weeks of differentiation (RPESC-RPE-4W) effectively replace the native RPE cells lost during AMD disease progression..

RPESC-RPE-4W是源自成人视网膜色素上皮干细胞(RPESC)的细胞产物,其产生视网膜色素上皮(RPE)细胞后代(RPESC-RPE)。分化四周后获得的祖细胞期RPESC-RPE细胞(RPESC-RPE-4W)的移植有效地替代了AMD疾病进展过程中丢失的天然RPE细胞。。

'We are honored to have CIRM recognize the potential of our unique technology utilizing precursor-stage RPE cells. Replacement of lost RPE cells with RPESC-RPE-4W aims to restore vision loss in patients with dry AMD and offers the potential to improve the quality of life,” said Jeffrey Stern, PhD, MD, co-founder of the NSCI..

“我们很荣幸CIRM认识到我们利用前体阶段RPE细胞的独特技术的潜力。用RPESC-RPE-4W替代丢失的RPE细胞旨在恢复干性AMD患者的视力丧失,并提供改善生活质量的潜力,”NSCI联合创始人杰弗里·斯特恩博士说。。

Dry AMD is a common eye disorder in people over 50. It is caused by the deterioration of the cells of the macula, as retinal cells die off and are not renewed. The condition results in reduced central vision and there are currently no treatments available to reverse the damage.

干性AMD是50岁以上人群常见的眼疾。它是由黄斑细胞的退化引起的,因为视网膜细胞死亡并且没有更新。这种情况会导致中央视力下降,目前还没有治疗方法可以扭转这种损害。

“RPESC-RPE-4W therapy represents a potential breakthrough in the treatment of dry AMD,” said Dr. Abla Creasey, PhD, Vice President of Therapeutics Development at CIRM. “We are impressed with the stem cell-based replacement approach developed by Luxa Biotechnology and delighted to support their groundbreaking efforts to restore vision and hope to patients with dry AMD.”.

CIRM治疗开发副总裁Abla Creasy博士说:“RPESC-RPE-4W疗法代表了干性AMD治疗的潜在突破。我们对Luxa Biotechnology开发的基于干细胞的替代方法印象深刻,很高兴支持他们为干性AMD患者恢复视力和希望所做的开创性努力。”。

Dr. Stern will present an update on the RPESC-RPE-4W trial on May 3, 2024, at the Foundation Fighting Blindness / Casey Eye Center Symposium, taking place in Seattle, Washington.

斯特恩博士将于2024年5月3日在华盛顿州西雅图举行的基金会抗击失明/凯西眼科中心研讨会上介绍RPESC-RPE-4W试验的最新情况。

About Luxa Biotechnology

关于Luxa Biotechnology

Luxa Biotechnology (LuxaBio) is a clinical-stage biotechnology company developing a novel adult RPE stem cell (RPESC) therapy for dry AMD. The proprietary adult RPESC-derived RPE stem cell product was developed at and licensed from the Neural Stem Cell Institute (NSCI). LuxaBio is a partnership between the NSCI research institute and Y2 Solution, a Korean company, to evaluate RPESC in a clinical trial to test the safety and efficacy of RPE progenitor stage progeny as a therapy for dry AMD.

Luxa Biotechnology(LuxaBio)是一家临床阶段生物技术公司,开发了一种新型成人RPE干细胞(RPESC)治疗干性AMD。专有的成人RPESC衍生的RPE干细胞产品由神经干细胞研究所(NSCI)开发并获得许可。LuxaBio是NSCI研究所和韩国Y2 Solution公司之间的合作伙伴,在临床试验中评估RPESC,以测试RPE祖细胞阶段后代作为干性AMD治疗的安全性和有效性。

LuxaBio maintains a robust research program at NSCI to develop the RPESC as an effective, commercially viable cell product. The Phase 1/2a clinical trial of RPESC-RPE-4W for the Treatment of Dry Age-related Macular Degeneration includes the Cedars Sinai Biomanufacturing Center, Emmes, the University of Michigan Kellogg Eye Center, the National Eye Institute For more information, please contact jeffreystern@luxabiotech.com.

LuxaBio在NSCI维持着一个强大的研究计划,将RPESC开发为一种有效的,商业上可行的细胞产品。RPESC-RPE-4W治疗干性年龄相关性黄斑变性的1/2a期临床试验包括Cedars-Sinai生物制造中心、Emmes、密歇根大学凯洛格眼科中心、国家眼科研究所。有关更多信息,请联系jeffreystern@luxabiotech.com.

About NSCI

关于NSCI

In 2005, Dr. Sally Temple and Dr. Jeffrey Stern founded the Regenerative Research Foundation and the Neural Stem Cell Institute (NSCI), the first independent stem cell research institute in the country. Rooted in discovery research, the administratively lean NSCI effectively advances laboratory discoveries to clinical application of regenerative stem cell therapies that address diseases of the central nervous system.

2005年,Sally Temple博士和Jeffrey Stern博士成立了再生研究基金会和神经干细胞研究所(NSCI),这是该国第一个独立的干细胞研究所。植根于发现研究,管理精益的NSCI有效地将实验室发现推进到再生干细胞疗法的临床应用,以解决中枢神经系统疾病。

NSCI is a non-profit discovery research Institute led by Dr. Sally Temple, the scientific director. The staff of 40 research staff is dedicated to advancing the understanding of neural stem cell biology work in cutting edge laboratories equipped for stem cell research. The retinal pigment epithelial stem cell (RPESC) was discovered at NSCI where in-depth characterization of this unique stem cell is ongoing.

NSCI是一家非营利性的发现研究机构,由科学总监萨利·坦普尔博士领导。40名研究人员致力于在配备干细胞研究的尖端实验室中提高对神经干细胞生物学工作的理解。视网膜色素上皮干细胞(RPESC)是在NSCI发现的,目前正在对这种独特的干细胞进行深入表征。

In 2022, NSCI partnered with Y2 Solution to create Luxa Biotechnology to advance the RPESC as therapy for dry age-related macular degeneration, in collaboration with the NIH National Eye Institute, Cedars-Sinai Biomanufacturing Center, Emmes Corporation, and the University of Michigan Kellogg Eye Center..

2022年,NSCI与Y2 Solution合作创建了Luxa Biotechnology,与NIH国家眼科研究所、Cedars-Sinai生物制造中心、Emmes Corporation和密歇根大学凯洛格眼科中心合作,将RPESC作为干性年龄相关性黄斑变性的治疗方法。。

About CIRM

关于CIRM

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies.

在CIRM,我们永远不会忘记,我们是由加利福尼亚州人民创建的,旨在加速对未满足医疗需求的患者进行干细胞治疗,并以紧迫感行动以成功完成这项任务。为了应对这一挑战,我们的团队由训练有素且经验丰富的专业人员组成,在动手创业的环境中积极与学术界和工业界合作,以快速跟踪当今最有前途的干细胞技术的发展。

With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world's largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to www.cirm.ca.gov.

CIRM拥有55亿美元的资金和150多个活跃的干细胞项目,是世界上最大的机构之一,致力于帮助人们实现细胞医学的未来。有关更多信息,请访问www.cirm.ca.gov。