Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients with Early Symptomatic Alzheimer's Disease

This phase 2a study will research the safety and tolerability of Foralumab, a human anti-CD3 antibody. An antibody is a molecule secreted by the immune system. These molecules are created to identify a specific pathogen. Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia, the brain's main immune cells. This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain. Alzheimer's disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain. This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.
The trial will ask participants to administer Foralumab nasally three times a week for eight weeks. The administration will occur intermittently, with breaks between each dosing cycle. Participants will also receive brain scans (Amyloid PET and MRI), undergo cognitive testing, blood draws, and physical, neurological, and nasal exams. Volunteers are expected to remain in the trial for six months.

开始日期2025-04-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

NCT06890923

/ Recruiting临床2期

An Open Label, Multicenter Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status.
All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.

开始日期2025-03-04

申办/合作机构

Tiziana Life Sciences Ltd.

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项与 Tiziana Life Sciences Ltd. 相关的文献（医药）

2004-02-01·The protein journal4区 · 生物学

The Alcohol-Induced Conformational Changes in Casein Micelles: A New Challenge for the Purification of Colostrinin

4区 · 生物学

Article

作者: Polanowski, Antoni ; Sokolowska, Agata ; Bednarz, Renata ; Pacewicz, Magdalena ; Kruzel, Marian L. ; Wilusz, Tadeusz ; Georgiades, Jerzy A.

Recent advances in protein separation technology have allowed for the isolation of whey proteins and peptides of significant biological importance. In this study, we report a novel method for isolation and purification of the neuroprotective proline-rich polypeptides, also known as Colostrinin (CLN). Although CLN was first isolated from ovine colostrum and characterized as a complex of small molecular peptides, its constituents are present also in other mammal colostrums. The previous purification protocols are very tedious, time consuming, and, due to the diverse characteristics of colostrum, also very difficult to validate. Thus, the aim of this study was to develop a simple protocol with a maximum recovery rate for CLN peptides. Here we demonstrate the two-step extraction/purification method that consists of methanol extraction and ammonium sulfate precipitation as the general principles. When compared with the original material, CLN obtained by this method shows (1) similar pattern of peptides in SDS PAGE, (2) identical amino acid analysis, characterized by high content of proline (22%), a high proportion of nonpolar amino acids, a low percentage of glycine, alanine, arginine, histidine, and no tryptophan, methionine, and cysteine residues, (3) similar pattern of HPLC profiles, and (4) its ability to induce IFN gamma and TNF alpha. More importantly, the protocol for the production of high-quality CLN can be accomplished in less than a 48 h timeframe. In addition, avoidance of excessively harsh conditions preserves the structure and biological activity of the peptides.

Journal of molecular neuroscience : MN3区 · 医学

Modulation of 4HNE-Mediated Signaling by Proline-Rich Peptides from Ovine Colostrum

3区 · 医学

Article

作者: Jerzy A. Georgiades ; Marian L. Kruzel ; Daniel Liebenthal ; Istvan Boldogh ; Terry L. Juelich ; G. John Stanton ; T. Kley Hughes

In previous studies we showed that colostrinin (CLN), a complex of proline-rich polypeptides derived from ovine colostrum, induces mitogenic stimulation, as well as a variety of cytokines in human peripheral blood leukocytes, and possesses antioxidant activity in pheochromocytoma (PC12) cells. In this study we investigated the effects of CLN on 4-hydroxynonenal (4HNE)-mediated adduct formation, generation of reactive oxygen species (ROS), glutathione (GSH) metabolism, and the modification of signal transduction cascade that leads to activation of c-Jun N-terminal kinase (JNK) in PC12 cells. Here we demonstrate that CLN (1) reduced the abundance of 4HNE-protein adducts, as shown by fluorescent microscopy and Western blot analysis; (2) reduced intracellular levels of ROS, as shown by a decrease in 2',7'-dichlorodihydro-fluorescein-mediated fluorescence; (3) inhibited 4HNE-mediated GSH depletion, as determined fluorimetrically; and (4) inhibited 4HNE-induced activation of JNKs. Together, these findings suggest that CLN appears to down-regulate 4HNE-mediated lipid peroxidation and its product-induced signaling that otherwise may lead to pathological changes at the cellular and organ level. These findings also suggest further that CLN could be useful in the treatment of diseases such as Alzheimer's, as well as those in which ROS are implicated in pathogenesis.

183

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2025-11-26

·GlobeNewswire-Health Care

Tiziana Life Sciences Nasal Foralumab Phase 2 Clinical Trial Accepted into Healey ALS MyMatch Program

Nov. 25, 2025 -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham. The study, supported by a grant from the ALS Association, will be led by Principal Investigators Suma Babu, MBBS, MPH, and James Berry, MD, MPH, at Mass General Brigham. The trial will enroll at multiple rapid-enrolling U.S. centers within the Network of Excellence for ALS (NEALS) Consortium. Successful investigational products from the Healey ALS MyMatch program may advance to future regimens of the HEALEY ALS Platform Trial – a perpetual, multi-regimen, late-phase clinical efficacy study – or transition directly to standalone Phase 3 trials. ALS is a serious neurodegenerative disease characterized by progressive motor neuron loss, leading to muscle weakness and paralysis. Neuroinflammation and immune dysregulation, particularly involving T-cell dysfunction and microglial activation, are increasingly recognized as key drivers of disease progression. Preclinical and clinical evidence indicate that nasally administered foralumab – a fully human anti-CD3 monoclonal antibody – stimulates regulatory T cells in cervical lymph nodes, which then migrate to the central nervous system to suppress pathogenic inflammation and restore microglial homeostasis. Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, stated: “The rapid progression to trial activation reflects the urgency of the ALS community and the compelling science behind nasal foralumab. By leveraging the immune-modulatory potential of the nasal route, we aim to deliver meaningful clinical impact with a non-invasive therapy. We are deeply grateful to the ALS Association for their partnership and to the NEALS Consortium for their operational excellence. Foralumab’s ability to expand regulatory T cells and dampen CNS inflammation offers a biologically rational approach to slowing progression in a genetically defined ALS population. We are eager to translate these mechanisms into patient benefit.” Suma Babu, MBBS, MPH, Principal Investigator of the ALS MyMatch program and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham, added: “This innovative multi-site randomized placebo-controlled trial will integrate innovative nasal immunology with cutting-edge blood, spinal fluid and cellular and advanced brain imaging markers to understand the effect of the drug.” ALS MyMatch is a multi-site, collaborative initiative that currently brings together four trial-ready, high enrolling ALS research centers and is a Network of Excellence for ALS (NEALS) affiliated program. Research centers include Mass General in Boston; University of Minnesota in Minneapolis, Minn.; Northwestern University in Evanston, Ill.; and Nova Southeastern University in Fort Lauderdale, Fla. ALS MyMatch has partnered with the Acceleration Centers of Enrollment (ACE) program, a community-driven philanthropic partnership program focused on expediting start up and recruitment at study centers. At the Sean M. Healey & AMG Center for ALS at Mass General Brigham, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development. Launched in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD and a Science Advisory Council of international experts, is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent it. Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. [1] https://www.pnas.org/doi/10.1073/pnas.2220272120 [2] https://www.pnas.org/doi/10.1073/pnas.2309221120 The content above comes from the network. if any infringement, please contact us to modify.

免疫疗法

2025-11-25

·动脉网

Tiziana生命科学公司鼻用Foralumab二期临床试验被Healey ALS MyMatch计划接受Tiziana Life Sciences Nasal Foralumab Phase 2 Clinical Trial Accepted into Healey ALS MyMatch Program

BOSTON, MA, November 25, 2025 美国马萨诸塞州波士顿，2025年11月25日– Tiziana Life Sciences, Ltd. (Nasdaq: – Tiziana Life Sciences, Ltd. (纳斯达克:TLSA TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies today announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the Sean M. ）（“Tiziana”或“公司”），一家开发突破性免疫调节疗法的生物技术公司，今天宣布其评估鼻内foralumab治疗肌萎缩侧索硬化症（ALS）患者的II期临床试验已被接受纳入Sean M. 的ALS MyMatch计划。Healey & AMG Center for ALS at Mass General Brigham.. Healey & AMG ALS中心，位于麻省总医院Brigham分院。The study, supported by a grant from the ALS Association, will be led by Principal Investigators Suma Babu, MBBS, MPH, and James Berry, MD, MPH, at Mass General Brigham. The trial will enroll at multiple rapid-enrolling U.S. centers within the Network of Excellence for ALS (NEALS) Consortium. Successful investigational products from the Healey ALS MyMatch program may advance to future regimens of the HEALEY ALS Platform Trial – a perpetual, multi-regimen, late-phase clinical efficacy study – or transition directly to standalone Phase 3 trials.. 这项研究由ALS协会的资助支持，将在麻省总医院布里格姆分院由首席研究员苏玛·巴布（Suma Babu），医学博士、公共卫生硕士，和詹姆斯·贝里（James Berry），医学博士、公共卫生硕士，领导进行。试验将在ALS卓越网络（NEALS）联盟内的多个快速招募的美国中心进行注册。来自Healey ALS MyMatch计划的成功试验产品可能会进入HEALEY ALS平台试验的未来方案——这是一项永久性、多方案、后期临床疗效研究——或直接过渡到单独的第三阶段试验。ALS is a serious neurodegenerative disease characterized by progressive motor neuron loss, leading to muscle weakness and paralysis. Neuroinflammation and immune dysregulation, particularly involving T-cell dysfunction and microglial activation, are increasingly recognized as key drivers of disease progression. ALS是一种严重的神经退行性疾病，其特征是进行性运动神经元丧失，导致肌肉无力和瘫痪。神经炎症和免疫失调，特别是涉及T细胞功能障碍和小胶质细胞激活，日益被认为是疾病进展的关键驱动因素。Preclinical and clinical evidence indicate that nasally administered foralumab – a fully human anti-CD3 monoclonal antibody – stimulates regulatory T cells in cervical lymph nodes, which then migrate to the central nervous system to suppress pathogenic inflammation and restore microglial homeostasis.. 临床前和临床证据表明，鼻腔给予的foralumab（一种完全人源化的抗CD3单克隆抗体）能够刺激颈淋巴结中的调节性T细胞，这些细胞随后迁移到中枢神经系统，抑制病理性炎症并恢复小胶质细胞的稳态。Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, stated: “The rapid progression to trial activation reflects the urgency of the ALS community and the compelling science behind nasal foralumab. By leveraging the immune-modulatory potential of the nasal route, we aim to deliver meaningful clinical impact with a non-invasive therapy. Tiziana生命科学公司首席执行官Ivor Elrifi表示：“快速推进试验启动反映了ALS社区的紧迫性以及鼻用foralumab背后的引人注目的科学依据。通过利用鼻腔途径的免疫调节潜力，我们的目标是通过一种非侵入性疗法实现显著的临床影响。”We are deeply grateful to the ALS Association for their partnership and to the NEALS Consortium for their operational excellence. Foralumab’s ability to expand regulatory T cells and dampen CNS inflammation offers a biologically rational approach to slowing progression in a genetically defined ALS population. 我们对ALS协会的合作关系深表感激，也感谢NEALS联盟的卓越运营。Foralumab能够扩增调节性T细胞并减轻中枢神经系统的炎症，这为减缓基因定义的ALS人群的病情进展提供了一个生物学上合理的方法。We are eager to translate these mechanisms into patient benefit.”. 我们渴望将这些机制转化为患者的益处。Suma Babu, MBBS, MPH, Principal Investigator of the ALS MyMatch program and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham, added: “This innovative multi-site randomized placebo-controlled trial will integrate innovative nasal immunology with cutting-edge blood, spinal fluid and cellular and advanced brain imaging markers to understand the effect of the drug”.. 苏玛·巴布（Suma Babu），医学博士、公共卫生硕士，ALS MyMatch 项目的主要研究者，麻省总医院布莱根神经临床研究中心（NCRI）的联合主任，补充道：“这项创新的多中心随机安慰剂对照试验将结合创新的鼻腔免疫学与前沿的血液、脑脊液、细胞以及先进的脑成像标志物，以了解该药物的效果。”A competitive grant has been awarded to Tiziana Life Sciences towards funding this study following rigorous peer review by the ALS Association. 经过ALS协会的严格同行评审，Tiziana Life Sciences已获得一项竞争性拨款，用于资助这项研究。About ALS MyMatch 关于ALS MyMatchALS MyMatch is a multi-site, collaborative initiative that currently brings together four trial-ready, high enrolling ALS research centers and is a Network of Excellence for ALS (NEALS) affiliated program. Research centers include Mass General in Boston; University of Minnesota in Minneapolis, Minn.; Northwestern University in Evanston, Ill.; and Nova Southeastern University in Fort Lauderdale, Fla. ALS MyMatch 是一项多站点合作计划，目前汇集了四个准备就绪、高注册率的 ALS 研究中心，并且是 ALS 卓越网络 (NEALS) 的附属项目。研究中心包括波士顿的麻省总医院、明尼苏达州明尼阿波利斯的明尼苏达大学、伊利诺伊州埃文斯顿的西北大学，以及佛罗里达州劳德代尔堡的诺瓦东南大学。ALS MyMatch has partnered with the. ALS MyMatch 已与...合作。Acceleration Centers of Enrollment 注册加速中心(ACE) program, a community-driven philanthropic partnership program focused on expediting start up and recruitment at study centers. Additional trials and high performing sites will be added as the program grows. Organizations can apply on the (ACE) 计划，一个由社区驱动的慈善合作伙伴关系计划，专注于加速研究中心的启动和招聘。随着计划的发展，将增加更多的试验和高效站点。组织可以在ALS MyMatch website ALS MyMatch 网站. 。About the Sean M. Healey & AMG Center for ALS at Mass General Brigham 关于肖恩·M·希利和AMG中心在麻省总医院布里格姆ALS中心At the Sean M. Healey & AMG Center for ALS at Mass General Brigham, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development.. 在麻省总医院布莱根ALS中心的肖恩·M·希利和AMG中心，我们致力于汇集全球范围内的科学家、医生、护士、基金会、联邦机构以及ALS患者、他们的亲人和护理人员，以加快ALS治疗的发现与开发进程。Launched in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD and a Science Advisory Council of international experts, is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent it. 2018年11月，在梅丽特·库德科维奇博士和一个国际专家科学顾问委员会的领导下，希利和AMG中心启动，该中心正在重新构想如何开发和测试最有希望的治疗方法来治疗这种疾病，寻找治愈方法并最终预防它。About Foralumab 关于ForalumabForalumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (. Foralumab是一种全人源抗CD3单克隆抗体，是一种生物药物候选物，已证明在鼻内给药时可刺激T调节细胞。目前，在一项开放标签的中等规模扩展使用（EA）项目中，已有14名非活动性继发进展型多发性硬化症（na-SPMS）患者接受了给药。NCT06802328 NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (. ）所有患者在6个月内病情均得到改善或稳定。此外，鼻内给药的foralumab目前正在一项2a期、随机、双盲、安慰剂对照、多中心、剂量范围试验中进行研究，针对非活动性继发进展型多发性硬化症（患者）。NCT06292923 NCT06292923). ）。Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases. Foralumab是目前临床开发中唯一的全人源抗CD3单克隆抗体（mAb）。通过鼻内给药的Foralumab进行免疫调节，代表了治疗神经炎症和神经退行性人类疾病的新途径。[1],[2] [1],[2]About Tiziana Life Sciences 关于蒂齐亚纳生命科学公司Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana Life Sciences是一家临床阶段的生物制药公司，利用变革性的药物递送技术开发突破性疗法，以实现免疫治疗的替代途径。Tiziana创新的鼻腔给药方法相比静脉注射（IV）有可能在疗效以及安全性和耐受性方面提供改善。Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.. Tiziana的主打候选药物——鼻腔给药的foralumab，是目前临床开发中唯一的全人源抗CD3单克隆抗体，在迄今为止的研究中已显示出良好的安全性和临床反应。Tiziana用于免疫治疗替代途径的技术已获得专利，还有多项申请正在审批中，预计将会为广泛的管线应用提供支持。For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit 欲了解有关Tiziana生命科学及其创新疗法的更多信息，请访问www.tizianalifesciences.com www.tizianalifesciences.com. 。For further inquiries: 如有进一步的询问：Tiziana Life Sciences Ltd 蒂齐亚娜生命科学有限公司Paul Spencer, Business Development, and Investor Relations 保罗·斯宾塞，业务发展与投资者关系+44 (0) 207 495 2379 +44 (0) 207 495 2379email: 电子邮件：info@tizianalifesciences.com info@tizianalifesciences.com[1] [1]https://www.pnas.org/doi/10.1073/pnas.2220272120 https://www.pnas.org/doi/10.1073/pnas.2220272120[2] [2]https://www.pnas.org/doi/10.1073/pnas.2309221120 https://www.pnas.org/doi/10.1073/pnas.2309221120

临床2期免疫疗法

2025-11-13

·GlobeNewswire-Health Care

Tiziana Life Sciences to Present at Jefferies Global Healthcare Conference

BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that its senior leadership team will present at the prestigious Jefferies London Healthcare Conference. Chief Executive Officer Ivor Elrifi and Chief Operating Officer/Chief Financial Officer Keeren Shah will deliver a corporate overview highlighting the Company’s innovative pipeline and recent clinical milestones. The session will include an update on the lead candidate foralumab, the only fully human anti-CD3 monoclonal antibody in clinical development administered intranasally for neurodegenerative diseases such as non-active secondary progressive multiple sclerosis (SPMS), Alzheimer’s disease (AD), multiple system atrophy (MSA) and amyotrophic lateral sclerosis (ALS). The Jefferies London Healthcare Conference is one of Europe’s premier investor forums, attracting leading global healthcare companies, institutional investors, and industry thought leaders. Tiziana’s participation underscores its growing visibility within the biotechnology investment community and its commitment to advancing transformative therapies for patients with high unmet medical needs. Presentation Details Event: Jefferies London Healthcare Conference Date: Wednesday, November 19, 2025 Time: 12:30 p.m. – 12:55 p.m. GMT (25-minute presentation) Location: London, UK Presenters: Ivor Elrifi, Chief Executive OfficerKeeren Shah, Chief Operating Officer and Chief Financial Officer Management will also be available for one-on-one meetings throughout the conference. Interested parties may request meetings through the Jefferies conference portal or by contacting Tiziana’s investor relations team.About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com [1] https://www.pnas.org/doi/10.1073/pnas.2220272120 [2] https://www.pnas.org/doi/10.1073/pnas.2309221120

临床2期免疫疗法

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管线布局

2025年11月27日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

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药物(靶点)	适应症	全球最高研发状态

TZLS-501 ( IL-6R )	炎症更多	临床前
Foralumab ( CD3ε )	克罗恩病更多	终止
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