The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and potentially prevent or reverse key parts of the aging process more generally. The study will evaluate biomarkers for epigenetic aging and immunosenescence, as well as evaluate established clinical measures and risk factors for prevention of physical frailty, cancer, cardiovascular disease, diabetes, dementia, and also infectious diseases, including flu and COVID-19.
The study uses multiple agents in combination with personalized doses of recombinant human growth hormone (somatropin), metformin, and DHEA, in a similar manner to how the combination treatment was applied in the earlier TRIIM trial at Stanford, which demonstrated strong statistical significance for the primary efficacy endpoints that will be evaluated in TRIIM-X. Somatropin is approved by the FDA for adult growth hormone deficiency and its use in the study is guided by prior safety data established for that use and also based on safety data available on its prior use in the TRIIM trial and in clinical practice in healthy elderly individuals. There will also be control groups that enable testing of biomarker variability and the contribution of individual medications within the combination treatment.
The objective of the study is to obtain information needed for designing an effective personalized and adaptive treatment regimen for a larger and more diverse study population, and to obtain additional proof of principle for the new use of the medications and biomarkers for preventive medicine. The duration of treatment in the TRIIM-X trial will be 12 months.

开始日期2020-11-23

申办/合作机构

Intervene Immune, Inc.

100 项与 Intervene Immune, Inc. 相关的临床结果

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0 项与 Intervene Immune, Inc. 相关的专利（医药）

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项与 Intervene Immune, Inc. 相关的文献（医药）

2020-06-28·Aging3区 · 医学

Reversing immunosenescence for prevention of COVID-19

3区 · 医学

Article

作者: Fahy, Gregory M. ; Brooke, Robert T.

2018-01-23·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

Questioning the inevitability of aging

1区 · 综合性期刊

Letter

作者: Fahy, Gregory M. ; Mitteldorf, Josh

Paul Nelson and Joanna Masel (1) are the most recent theorists to bypass evolution and seek an abstract answer to the question, “What is the cause of aging?” Their mathematics is not in question, but the process of somatic evolution that they model bears no obvious relation to aging as it has been characterized in humans. Regrettably, their result has been caricatured in the popular press to discredit medical research toward delayed aging. The Nelson/Masel theory applies to multicellular life, but aging first evolved in bacteria (2) and then in protists (3). The genetics of aging in protists is homologous to … [↵][1]1To whom correspondence should be addressed. Email: aging.advice{at}gmail.com. [1]: #xref-corresp-1-1

项与 Intervene Immune, Inc. 相关的新闻（医药）

2026-01-20

·OURSUN健康抗衰

时间可以倒流吗？在生物学意义上，答案是肯定的——三种老药让9人一年治疗逆转25年衰退，震惊了全球科学界！

一年逆转25年衰退？三位科学家的"药物鸡尾酒"REWRITING ANTI-AGING HISTORY 抗衰研究 "无论你多老,你的身体依然记得年轻时的模样。那份关于青春的记忆并没有消失,它只是随着岁月的流逝,在你的基因组深处沉睡了。但它从未离去,并且,它可以被唤醒。" 2019年的那个深夜 2019年9月,加州大学洛杉矶分校的实验室里,一位名叫Steve Horvath的遗传学家正盯着电脑屏幕上的数据发呆。他反复检查了好几遍,甚至怀疑是不是系统出了bug。眼前的结果显示:经过一年的治疗,9名51-65岁的男性受试者,他们的**生物学年龄平均减少了2.5岁**。 "我本以为能看到衰老减缓,但没想到竟然还能逆转。这真是有点儿未来感!"Horvath后来回忆道。这个结果发表在《Aging Cell》期刊上,瞬间引爆了整个科学界。因为这是人类历史上首次有证据表明:**衰老不是一个单向的、不可逆的过程,而是可以被逆转的。** 故事一:冷冻专家的意外发现这一切要从Gregory Fahy博士说起。他是低温生物学领域的泰斗,一生都在研究如何"冻"住器官,为未来的器官移植技术铺路。 1986年,36岁的Fahy读到一篇发表在《美国科学院院刊》(PNAS)上的研究论文。研究人员把能持续分泌生长激素的细胞移植到年老的小鼠体内,竟然发现这些小鼠萎缩的胸腺**重新长出了功能组织**,免疫系统也恢复了活力。胸腺位于胸骨后方,是人体的免疫"军校"。骨髓中的干细胞在这里发育成熟的T细胞,学会了识别敌我,成为抵抗感染和癌症的主力军。但遗憾的是,从青春期开始,胸腺就开始不可逆地退化,功能性组织逐渐被脂肪吞噬。到50岁时,胸腺几乎完全变成了脂肪,人体对新威胁的应对能力急剧下降。如果能让胸腺"逆生长",岂不是意味着人类可以重建免疫防线,甚至延长寿命? Fahy立刻开始向周围的人宣传这个发现,但令人意外的是,科学界反应冷淡。几次尝试后,他决定自己来验证。 1996年,46岁的Fahy拿自己"开刀"。他给自己注射生长激素(GH),同时补充脱氢表雄酮(DHEA)。一个月后,MRI扫描显示,他的胸腺功能体积从正常范围跃升到了同龄人平均值的三倍标准差以上。这次**人体自试验**的结果令人振奋,但依然没能引起太多关注。直到2015年,在投资伙伴Bobby Brooke的支持下,Fahy终于启动了正式的临床试验——**TRIIM(胸腺再生、免疫恢复和胰岛素缓解)试验**。故事二:三味老药的巧妙组合 Fahy面临的第一个难题是安全性。生长激素虽然能刺激胸腺再生,但它有一个致命的副作用——**推高胰岛素水平,容易引发糖尿病**,长期使用甚至可能增加癌症风险。这就像你想给汽车加速(胸腺再生),但发动机却越来越热(糖尿病风险)。经过深思熟虑,Fahy设计了一套"鸡尾酒"配方: 第一种药物:生长激素(GH)这是整个方案的核心,负责刺激胸腺组织再生。已有研究表明,GH能通过IGF-1通路逆转胸腺退化,增加T细胞受体多样性,促进造血系统恢复。第二种药物:脱氢表雄酮(DHEA)DHEA是一种青春激素,在年轻人体内含量丰富,但随年龄增长而急剧下降。它的作用是**抵消GH引发的胰岛素抵抗**,同时改善记忆和情绪。研究表明,DHEA还具有抗糖皮质激素作用,而糖皮质激素会导致胸腺萎缩。第三种药物:二甲双胍这款糖尿病药物用于进一步提升胰岛素敏感性,在保留GH再生潜力的同时规避代谢风险。更有趣的是,近年来研究发现二甲双胍本身就有**延缓衰老**的效果,能降低癌症和心血管疾病风险。 "这不仅仅是阻断副作用,"Fahy解释道,"DHEA和二甲双胍除了能控制胰岛素水平外,自身也被证明具有独立的抗衰老作用。这种组合让我们得以利用生长激素再生胸腺,同时避免诱发类糖尿病状态。" 故事三:超越预期的惊人结果 2015年5月,美国FDA批准了这项试验。9名51-65岁的健康白人男性参与其中,在斯坦福医学中心接受了一年的治疗。治疗期间的监测数据让团队既兴奋又忐忑。他们最担心的是癌症风险——有研究表明,长期高水平IGF-1(生长激素的下游产物)暴露可能增加前列腺癌风险。但随着数据的不断传来,结果出乎所有人的意料: ✓ 癌症风险指标不升反降受试者的前列腺特异性抗原(PSA)水平显著下降,这意味着癌症风险实际上降低了。 ✓ 胸腺再生得到证实MRI扫描显示,7名受试者胸腺内堆积的脂肪组织正逐渐被新生的功能性组织所替代。 ✓ 免疫系统全面恢复初始T细胞数量显著增加,这些"新兵"能识别和应对新威胁;PD-1阳性CD8 T细胞(一种功能耗竭的免疫细胞)大幅减少,这相当于**免费使用了价值数十亿美元的抗癌药**。但最让团队震惊的是表观遗传时钟的数据。表观遗传时钟是测量生物学年龄的金标准,通过分析DNA上的甲基化标记点来评估一个人的真实衰老程度。经过一年治疗,受试者的生物学年龄平均减少了1.5年(若计入试验时长,相当于逆转了2.5年的衰老进程)。 "这本来只是我们要逆转免疫衰老这块蛋糕上的糖霜,"Fahy坦言,"结果却成了最震撼的证据。" 更令人兴奋的是,停药6个月后,这种逆转效果依然存在。6名提供最终血样的参与者,表观遗传年龄仍然保持在年轻状态。从质疑到验证:科学的力量然而,这项研究也引来了巨大争议。毕竟: - 样本量只有9人- 没有设立对照组- 全是白人男性- 存在安慰剂效应的可能性面对质疑,Intervene Immune团队没有退缩。他们启动了规模更大的**TRIIM-X试验**,招募不同性别、种族和年龄层(40-80岁)的参与者,采用更严谨的"交叉设计"让受试者既当对照组又当实验组。 2025年,Intervene Immune成功闯入XPRIZE Healthspan全球前40强。这个总奖金高达1.01亿美元的竞赛要求参赛团队在12个月内逆转受试者10年以上的衰老。根据团队披露的数据,TRIIM-X试验的逆转效应更加惊人:仅一年治疗,受试者在最大摄氧量(VO2max)和肌力等指标上的改善,已相当于**逆转了20至25年的自然衰退**。 "你的60岁的身体,被拉回了40岁的机能,"团队这样解释道。机制解析:为什么能逆转衰老? 为什么这套简单的药物组合能有如此强大的抗衰效果?科学家们给出了三个层面的解释: 1. 免疫系统层面的修复胸腺是免疫系统的核心器官。研究表明,胸腺退化是衰老的一个主要驱动因素。通过再生胸腺,可以:增加初始T细胞输出 :初始T细胞能识别新病原体,而衰老个体的免疫系统只能依赖记忆T细胞,对新威胁反应迟钝重建免疫多样性 :年轻免疫系统有数百万种不同的T细胞受体,能应对各种威胁,而老年免疫系统受体多样性急剧下降逆转免疫衰老特征 :PD-1阳性T细胞减少意味着免疫系统功能恢复,能更有效地识别和清除癌细胞 2. 表观遗传层面的重编程表观遗传改变是衰老的核心机制之一。随着年龄增长,DNA上的甲基化模式会发生系统性变化,这被称为"表观遗传漂移"。有趣的是,这种漂移是有规律的,科学家因此可以构建"表观遗传时钟"来测量生物学年龄。 3. 系统性效应三种药物通过不同机制产生协同效应:GH :刺激胸腺再生,促进肌肉生长,改善记忆和情绪,促进神经发生DHEA :抵消GH的致糖尿病效应,抗炎,改善神经功能二甲双胍 :激活AMPK通路,抑制mTOR通路,这两者都与衰老密切相关未来展望:何时能用上? 好消息是,这项技术离普通人的生活可能比你想象的更近。监管路径巧妙Intervene Immune计划通过"治疗免疫缺陷"或"改良型生物药"的路径寻求FDA批准,而不是在"治疗衰老"这个监管死胡同里死磕。这大大缩短了上市时间。 AI剂量系统团队正在开发一套AI剂量系统,未来即便不是抗衰专家,普通医生也能在AI辅助下为患者开具个性化处方。组合治疗的前景Intervene Immune并不打算单打独斗。未来他们的方案将与外泌体、线粒体输注、甚至基因编辑和细胞重编程等前沿技术联手,通过多技术路径的联合干预,提升整体抗衰效果。科学家的警示尽管前景诱人,但专家们也给出了重要提醒: ❌ 不要自行用药"自行使用生长激素是非常危险的,"Fahy警告道,"必须在专业医生指导下进行,需要频繁监测血液指标,这既不简单也不便宜。" 生长激素的副作用包括: 腕管综合征关节僵硬胰岛素抵抗理论上的癌症风险(尽管TRIIM试验显示风险反而降低) ✓ 可以尝试的部分对于无法参与临床试验的人,Fahy建议:二甲双胍 :这是最安全的抗衰老药物之一,有大量研究支持其延寿效果监测DHEA水平 :随着年龄增长,适量补充DHEA到年轻生理范围生活方式干预 :地中海饮食、充足睡眠、减轻压力、高强度间歇训练参考文献与延伸阅读 1. Fahy GM, Brooke RT, Watson JP, et al. Reversal of epigenetic aging and immunosenescent trends in humans. Aging Cell. 2019;18:e13028. DOI: 10.1111/acel.13028 2. Taub DD, Murphy WJ, Longo DL. Rejuvenation of the aging thymus: growth hormone-mediated and ghrelin-mediated signaling pathways. Curr Opin Immunol. 2010;22(4):521-528. 3. Liang Z, Dong X, Zhang Z, et al. Age-related thymic involution: Mechanisms and functional impact. Aging Cell. 2022;21(3):e13665. 4. Palmer S, Albergante L, Blackburn CC, Newman TJ. Thymic involution and rising disease incidence with age. Proc Natl Acad Sci U S A. 2018;115(8):1883-1888. 5. Reis MD, Veneziani LP, Porto F, Savino W. Thymic Rejuvenation: Are We There Yet? Vitam Horm. 2021;113:193-217. 6. Barzilai N, Crandall JP, Kritchevsky SB, Espeland MA. Metformin as a tool to study aging. Cell Metab. 2016;23(6):1060-1065. 7. Bodey B, Bodey BJ, Siegel SE, Kaiser HE. Involution of the mammalian thymus, one of the leading regulators of aging. In Vivo. 1997;11(5):421-440. 8. Hirokawa K, Utsuyama M, Kobayashi S. Hypothalamic aging and hormones. Vitam Horm. 2021;113:259-278. 9. Savino W, Mendes-da-Cruz DA, Silva JS, et al. Neuroendocrine regulation of thymus physiology: role of growth hormone and luteinizing hormone-releasing hormone. J Neuroimmunol. 2002;125(1-2):12-18. 10. Ventevogel MS, Sempowski GD. Thymic rejuvenation: a new approach to treat immunosenescence. J Clin Invest. 2013;123(6):2357-2360. 免责声明：本平台对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完善性提供任何明示或暗示的保证，仅供读者参考，本公众平台将不承担任何责任关注我们,获取更多前沿医学科普

临床研究细胞疗法

2022-06-08

·PRNewswire

Anti-aging Therapeutics Market worth $ 2013.5 Million by 2030 - Exclusive Report by InsightAce Analytic

JERSEY CITY, N.J., June 8, 2022 /PRNewswire/ -- InsightAce Analytic Pvt. Ltd. announces the release of market assessment report on "Global Anti-aging Therapeutics Market (Type of Molecule (Biologics and Small Molecules), Type of Aging (Cellular Aging, Immune Aging, Metabolic Aging and Others), Mechanism of Action (Senolytic, Cell Regeneration, mTOR inhibitor/Modulator, AMP-kinase/AMP Activator, Mitochondria Inhibitor/Modulator and Others))– Industry Analysis, Competitive Landscape, Revenue Forecast 2020-2030" According to the latest research by InsightAce Analytic, the global Anti-aging Therapeutics market size valued at US$ 518.86 million in 2021, and it is expected to reach US$ 2013.51 million in 2030, recording a promising CAGR of 16.53% during the period of 2022-2030. Request for Sample Pages: Aging populations are increasing the prevalence of age-related illnesses, causing individual and social concerns. The demand for effective regenerative medicine solutions for the elderly is higher than ever. Anti-Aging Therapeutics has emerged as a new medical science field. Anti-aging diagnosis and medicine, which is a subset of medical and healthcare, uses modern science and medical technology to identify, prevent, cure, and reverse age-related dysfunctions, illnesses, and diseases. Several cell, insect, and animal models may be useful beginning areas in the development of anti-aging medicines prior to human trials. Interest and expenditure in anti-aging medicines are rising exponentially as living conditions improve. Several companies have also focused their efforts on stem cells and regenerative medicine. Given the numerous applications of stem cells, applications in regenerative medicine are far beyond ageing disorders and illnesses. Nonetheless, a few organizations have concentrated specifically on age-related problems. For instance, In Feb 2021, Cambrian Biopharma received $60 million in private funding for the development of anti-aging medications. The "Nine Hallmarks of Aging," which include cellular senescence, persistent tissue inflammation, and mitochondrial malfunction, are the focus of research of Cambrian scientists. Researchers are utilizing advancements in immunology, genomics, and epigenetics, as well as technologies ranging from gene editing to novel stem cell treatments. There is substantial potential for anti-aging therapeutics companies that effectively launch longevity treatments. Despite these encouraging breakthroughs in the field of ageing, a number of barriers will become obvious once an anti-aging medicine undergoes the demanding clinical trial procedure. Market growth is primarily related to a rise in demand for individualized, precise, preventative, and participative ageing therapies, as well as an increase in the Geriatric Population. As a result, as the number of the elderly rises, so does the need for anti-aging treatments. Increased technological advancements and R&D spending on anti-ageing products are propelling the market forward. To meet the growing demand for technologically advanced solutions among customers, companies in the field have mainly developed revolutionary anti-ageing therapeutics products. With a rising healthcare industry, North America is expected to have the largest revenue shares in 2022. Research and development into pharmaceuticals are rising in major economies such as the United States and Canada, and this is due to the increased investment in pharmaceutical design, production as well as research into senescent cells. Moreover, Asia Pacific is the world's most populous region, and it has a sizable market for anti-aging therapeutics. The ever-increasing proportion of elderly people in the population is a potential customer base for anti-aging treatments, driving regional growth. Enquiry Before Buy: Major key Players in the Anti-aging Therapeutics market are AgelessRx, ANOVA Institute for Regenerative Medicine, Betterhumans, BioAge Labs, BIOPHYTIS BSA, bioXcellerator, Cambrian Biopharma, CytoMed Therapeutics, Gero.ai, Rejuvenate Bio, Rejenevie Therapeutics, UT Health San Antonio, MyMD Pharmaceuticals, Intervene Immune, Inc. , CohBar, Inc., Alkahest, Athersys Inc, BHB Therapeutics, Biosplice, Cyclo Therapeutics, Denali Therapeutics, Elysium Health, Genome Protection, GenSight Biologics, Intervene Immune, Khondrian, Longeveron, LyGenesis, Mesoblast, Minovia Therapeutics, Mitobridge, Navitor Pharmaceuticals, NeuroTrack, Nuchido, NuSirt, OneSkin Technologies, PharmatrophiX, Proteostasis Therapeutics, Retrotope, Stealth Biotherapeutics, TA Sciences, Unity Biotechnology Younger Phenotype, and Other Prominent Players Recent Key Developments: In Feb 2022, Cambrian Biopharma announced that it had entered into a licence arrangement with Novartis to promote innovative, selective drugs that target the mechanistic target of rapamycin (mTOR) pathway. These compounds were conceived and characterized by Novartis. Cambrian Biopharma informed via a statement that the licensed assets are structural analogues of the FDA-approved drug rapamycin. This drug has been shown to prevent or reverse multiple age-related health deficits in mice and to extend their average lifespan by up to 31 %, according to the information provided by Cambrian Biopharma. In May 2019, Rejenevie™ Therapeutics announced the initiation of the Company's Phase II clinical trial to explore the safety and effectiveness of its unique AR-100 immune restoration treatment to increase the function of the ageing immune system. The clinical-stage biotechnology company develops first-in-world stem cell restoration medicines targeting age-related disorders. In April 2022, MyMD Pharmaceuticals Inc. accelerated the dosing of additional patients in the Company's fully funded Phase 2 clinical study of lead drug candidate MYMD-1 as a treatment for delaying ageing and extending a healthy lifespan. The double-blind, placebo-controlled, randomized Phase 2 research (NCT05283486) explores the effectiveness, safety, and pharmacokinetics of MYMD-1® in the treatment of people aged 65 years or older with chronic inflammation associated with sarcopenia/frailty. Market Segments Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2030 based on Type of Molecule Biologics Small Molecules Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2030 based on Type of Aging Cellular Aging Immune Aging Metabolic Aging Others Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2030 based on Mechanism of Action Senolytic Cell Regeneration mTOR inhibitor/Modulator AMP-kinase/AMP Activator Mitochondria Inhibitor/Modulator Others Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2030 based on Region North America Europe Asia Pacific Latin America Middle East & Africa North America Anti-aging Therapeutics market revenue (US$ Million) by Country, 2020 to 2030 U.S. Canada Europe Anti-aging Therapeutics market revenue (US$ Million) by Country, 2020 to 2030 Germany France Italy Spain Russia Rest of Europe Asia Pacific Anti-aging Therapeutics market revenue (US$ Million) by Country, 2020 to 2030 India China Japan South Korea Australia & New Zealand Latin America Anti-aging Therapeutics market revenue (US$ Million) by Country, 2020 to 2030 Brazil Mexico Rest of Latin America Middle East & Africa Anti-aging Therapeutics market revenue (US$ Million) by Country, 2020 to 2030 GCC Countries South Africa Rest of Middle East & Africa Why should buy this report: To receive a comprehensive analysis of the prospects for global Anti-aging Therapeutics market To receive industry overview and future trends of global Anti-aging Therapeutics market To analyse the Anti-aging Therapeutics market drivers and challenges To get information on Anti-aging Therapeutics market size value (US$ Mn) forecast till 2030 Major Investments, Mergers & Acquisition in global Anti-aging Therapeutics market industry For Customization @ Other Related Reports Published by InsightAce Analytic: Global Longevity and Anti-Senescence Therapy Market Global Antisense Oligonucleotide Therapeutics Market Global Anti-Ageing Products Services and Devices Market About Us: InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner. Contact Us: InsightAce Analytic Pvt. Ltd. Tel.: +1 718 593 4405 Email: [email protected] Site Visit: Follow Us on LinkedIn @ bit.ly/2tBXsgS Follow Us On Facebook @ bit.ly/2H9jnDZ SOURCE InsightAce Analytic Pvt. Ltd.

寡核苷酸小分子药物并购

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