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BioRestorative Therapies Enhances Preclinical Metabolic Program With a Novel Exosome-Based Biologic Targeting Obesity

BioRestorative Therapies Enhances Preclinical Metabolic Program With a Novel Exosome-Based Biologic Targeting Obesity

生物修复疗法通过基于外泌体的新型生物制剂靶向肥胖增强临床前代谢计划
GlobeNewswire ·  05/08 07:30

New therapeutic candidate developed using Company's patented ThermoStem platform

使用公司专利的ThermoStem开发的新候选疗法 平台

— Candidate has potential to serve as an adjuvant to existing pharmaceuticals that are FDA approved and marketed towards weight loss

— 候选药物有可能用作美国食品药品管理局批准并上市的用于减肥的现有药物的辅助剂

— DMF submission and commencement of first-in-human studies targeted for before the end of 2024

— DMF 提交并开始计划在 2024 年底之前进行的首次人体研究

Expanding the use of ThermoStem may open the door to big pharma partnership opportunities

扩大 ThermoStem 的使用范围 可能会为大型制药公司的合作机会打开大门

MELVILLE, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ("BioRestorative", "BRTX" or the "Company") (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced its development of a novel exosome-based biologic program targeting obesity.

纽约州梅尔维尔,2024 年 5 月 8 日(GLOBE NEWSWIRE)— 生物修复疗法公司。(“BioRestorative”、“BRTX” 或 “公司”)(纳斯达克:BRTX)是一家专注于干细胞疗法的临床阶段公司,今天宣布开发一项针对肥胖的新型基于外泌体的生物制剂计划。

BioRestorative currently anticipates initiating the formal U.S. Food and Drug Administration ("FDA") process for this ThermoStem-based therapeutic candidate by filing a Drug Master File ("DMF") in the third quarter of 2024. The Company aims to initiate first-in-human clinical studies before the end of the year.

BioRestorative目前预计将启动该ThermoStem的正式美国食品药品监督管理局(“FDA”)程序在2024年第三季度提交药物主档案(“DMF”),以候选治疗为基础。该公司的目标是在年底之前启动首次人体临床研究。

Exosomes are small extracellular vesicles secreted by various cells, including stem cells. They are understood to be important mediators of intercellular communication, and have been found to play a role in adipose (fat) metabolism by transporting cargo, such as non-coding RNAs (ncRNA), proteins, and other factors that may impact weight loss. Previously published peer-reviewed preclinical data from a study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional brown adipose derived stem cells, formulated using BioRestorative's proprietary ThermoStem platform, produced significant reductions in weight (consistent with losses achieved by GLP1 drugs) and blood glucose levels in a diet induced obesity model in mice.

外泌体是由包括干细胞在内的各种细胞分泌的小细胞外囊泡。据了解,它们是细胞间通信的重要介质,并被发现通过运输货物(例如非编码RNA(ncRNA)、蛋白质和其他可能影响减肥的因素,在脂肪(脂肪)代谢中发挥作用。以前 已出版 与犹他大学医学院合作进行的一项研究的经过同行评审的临床前数据表明,使用BioRestorative专有的ThermoStem配制而成的功能性棕色脂肪衍生干细胞 该平台,在饮食诱导肥胖模型中,小鼠体重(与GLP1药物的减肥效果一致)和血糖水平显著降低。

BioRestorative's ThermoStem platform has a comprehensive portfolio of issued patents that cover both the U.S. and international markets. This broad intellectual property portfolio can be leveraged across drugs that are currently approved and marketed for weight loss, potentially opening the door to future big pharma partnership opportunities for the Company.

BioRestorative 的热系统 平台拥有全面的已颁发专利组合,涵盖美国和国际市场。这种广泛的知识产权组合可以用于目前已获批准和上市的减肥药物,这有可能为公司未来的大型制药公司合作机会打开大门。

"We believe that our proprietary ThermoStem technology platform has immense potential to develop both best-in-class and first-in-class therapies to treat obesity, such as this exosome-based biologic candidate," said Lance Alstodt, BioRestorative's Chief Executive Officer. "While tremendous progress has been made in the fight against obesity, there is no question that significant unmet need remains. As an adjuvant to approved and marketed weight loss drugs, we believe that our new therapeutic candidate may allow for lower dosing, as well as prevent or minimize potential of muscle mass loss and negative cardiovascular effects."

“我们相信我们专有的 ThermoStem BioRestorative首席执行官兰斯·阿尔斯托特说,技术平台具有巨大的潜力,可以开发一流和一流的肥胖症治疗疗法,例如这种基于外泌体的候选生物制剂。“尽管在抗击肥胖方面取得了巨大进展,但毫无疑问,仍然存在大量未满足的需求。作为已获批准和上市的减肥药物的辅助剂,我们认为我们的新候选疗法可以降低剂量,并防止或最大限度地减少肌肉质量损失和对心血管的负面影响。”

About BioRestorative Therapies, Inc.

关于生物修复疗法公司

BioRestorative () develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:

生物修复剂()使用细胞和组织方案开发治疗产品,主要涉及成体干细胞。如下所述,我们的两个核心临床开发项目与椎间盘/脊柱疾病和代谢障碍的治疗有关,我们最近还开始提供BioCosmeCeutical产品:

• Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's own) cultured mesenchymal stem cells collected from the patient's bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient's bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient's damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

• 光盘/脊柱程序 (brtxDisc)):我们的主要候选细胞疗法 BRTX-100 是由从患者骨髓中收集的自体(或个人自己的)培养的间充质干细胞配制而成的产品。我们打算将该产品用于非手术治疗腰骶椎间盘疼痛性疾病,或作为外科手术的补充疗法。BRTX-100 生产过程采用专有技术,包括收集患者的骨髓、从骨髓中分离和培养干细胞以及对细胞进行冷冻保存。在门诊手术中,医生应将 BRTX-100 注射到患者受损的椎间盘中。该治疗适用于未通过非侵入性手术缓解疼痛且可能面临手术前景的患者。我们已经开始一项使用 BRTX-100 治疗由椎间盘退行性疾病引起的慢性下背部疼痛的 2 期临床试验。

• Metabolic Program (ThermoStem): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells ("BADSC") to generate brown adipose tissue ("BAT"), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.

• 代谢计划(ThermoStem)):我们正在开发基于细胞的候选疗法,使用棕色脂肪(脂肪)衍生干细胞(“BADSC”)来生成棕色脂肪组织(“BAT”)以及BADSC分泌的外泌体,以靶向肥胖和代谢障碍。BAT 旨在模仿天然存在的调节人类代谢动态平衡的棕色脂肪库。初步的临床前研究表明,动物体内棕色脂肪含量的增加可能是卡路里燃烧量增加以及葡萄糖和脂质水平降低的原因。研究人员发现,棕色脂肪含量较高的人患肥胖和糖尿病的风险可能会降低。BADSC 分泌的外泌体也可能影响减肥。

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA)-approvals in the emerging BioCosmeceuticals space.

• 生物药妆品:我们运营商业生物药妆平台。我们目前的商用产品采用我们的 cGMP ISO-7 认证无尘室配制和制造,是一种含有外泌体、蛋白质和生长因子的细胞分泌体。这种专有的生物精华由我们专门设计,可减少细纹和皱纹的出现,并带来其他领域的美容功效。展望未来,我们还打算探索通过研究性新药(IND)支持研究扩大我们的商业产品的可能性,将更广泛的基于细胞的生物美容产品和疗法包括在内,目的是在新兴的生物化妆品领域开创美国食品药品监督管理局(FDA)的批准。

Forward-Looking Statements

前瞻性陈述

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

本新闻稿包含经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的 “前瞻性陈述”,此类前瞻性陈述是根据1995年《私人证券诉讼改革法》的安全港条款作出的。请注意,此类陈述存在多种风险和不确定性,由于各种因素和其他风险,包括但不限于公司向美国证券交易委员会提交的最新10-K表格中规定的风险,这些风险和不确定性可能导致未来的情况、事件或结果与前瞻性陈述中的预测存在重大差异。在评估此处包含的前瞻性陈述时,您应考虑这些因素,不要过分依赖此类陈述。本新闻稿中的前瞻性陈述是截至本新闻稿发布之日作出的,公司没有义务更新此类陈述。

CONTACT:

联系人:

Email: ir@biorestorative.com

电子邮件: ir@biorestorative.com


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