Imilecleucel-T(Imilecleucel-T) - _专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名

Imilecleucel-T (USAN)、Tovaxin、Tcelna

靶点-

作用机制

免疫刺激剂、T淋巴细胞刺激剂

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [2]

在研适应症-

非在研适应症

脑萎缩子宫颈原位癌临床孤立综合征+ [3]

原研机构

Opexa Therapeutics, Inc.

在研机构-

非在研机构

Opexa Therapeutics, Inc.

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Imilecleucel-T 相关的临床试验

NCT01684761 / Completed临床2期

A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis

The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (SPMS).

开始日期2012-08-01

申办/合作机构

Opexa Therapeutics, Inc.

NCT00595920 / Terminated临床2期

An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.

开始日期2007-11-01

申办/合作机构

Opexa Therapeutics, Inc.

NCT00587691 / Completed临床1/2期

An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.

开始日期2002-07-01

申办/合作机构

Opexa Therapeutics, Inc.

100 项与 Imilecleucel-T 相关的临床结果

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100 项与 Imilecleucel-T 相关的转化医学

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100 项与 Imilecleucel-T 相关的专利（医药）

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4

项与 Imilecleucel-T 相关的文献（医药）

2015-08-01·Regenerative Medicine

Latest Developments in the Field of Stem Cell Research and Regenerative Medicine Compiled from Publicly Available Information and Press Releases from Nonacademic Institutions 1 February–31 March 2015

Article

作者: Ilic, Dusko

Dusko Ilic Stem Cell Laboratories, Guy’s Assisted Conception Unit, Division of Women’s Health, King’s College London Faculty of Life Sciences & Medicine, London, UK dusko.ilic@kcl.ac.uk Collaborations, partnerships & alliances Co-development agreement: Merck Serono & Otsuka Merck (Germany; www.merckgroup.com) subsidiary Merck Serono (Germany; www. merckserono.com) has amended its development and license deal with Opexa Therapeutics (TX, USA; www.opexatherapeutics. com) for Tcelna (imilecleucel-T), handing over US$3 million to further support an ongoing trial with the personalized immunotherapy for multiple sclerosis. Merck’s payment will help fund the current Phase IIb clinical study assessing Tcelna for patients with secondary progressive multiple sclerosis, as well as support planning of potential late-stage trials. Under their original 2013 deal, Merck Serono paid Opexa a US$5 million upfront fee for the option to exclusively license Tcelna – a potential first-in-class personalized therapy, which has received USA fast-track designation for the treatment of multiple sclerosis. Merck’s option can be exercised prior to or upon completion of the ongoing midstage study, top-line data from which is expected in the second half of 2016. If this occurs, Merck will pay Opexa another US$25 million (or US$15 million, depending upon whether certain conditions are met) for worldwide development and commercial rights excluding Japan, and fund its further development.

2011-07-01·Expert Opinion on Biological Therapy3区 · 医学

Tovaxin for multiple sclerosis

3区 · 医学

Review

作者: Rivera, Victor M

INTRODUCTIONA potential therapeutic possibility for multiple sclerosis (MS) is provided by Tovaxin, a personalized autologous T-cell immunotherapy utilizing myelin-reactive lymphocytes from peripheral blood.AREAS COVEREDThis review covers the production of the vaccine, which follows a series of steps after the acquisition of T-cells. This includes identification of the subsets that are myelin reactive, expansion ex vivo and, also extrinsically, inactivation of their replication capacity by cellular irradiation. Once attenuated, the modified cells are reintroduced into the donor. This process appears to induce a vigorous immune response towards specific populations of autoreactive T-cells determined to attack the myelin and its derivatives by trafficking from the vascular space into the CNS in MS. Historical aspects of the T-cell vaccination with Tovaxin, the process to obtain reactive T-cells and their attenuation techniques ex vivo are described. The clinical results obtained from clinical trials are also discussed.EXPERT OPINIONThe process of T-cell vaccination is complicated and presents some limitations. Further studies are required to provide scientific support and clinical evidence of the efficacy of Tovaxin in MS.

2009-05-01·Clinical Immunology3区 · 医学

Autologous attenuated T-cell vaccine (Tovaxin®) dose escalation in multiple sclerosis relapsing–remitting and secondary progressive patients nonresponsive to approved immunomodulatory therapies

3区 · 医学

Article

作者: S. Inman ; D. Rill ; J.C. Williams ; K. Von Gynz-Rekowski ; B. Loftus ; P. Garces ; M. Montgomery ; J. Zhang ; B. Newsom ; M. Riser

An open-label dose escalation study of T-cell vaccination in multiple sclerosis patients was conducted using attenuated myelin reactive T-cells (MRTC) selected with six myelin peptides, two each from MBP, PLP and MOG. The dose range of subcutaneous injections given at weeks 0, 4, 12 and 20 was 6-9E6, 30-45E6 and 60-90E6 irradiated MRTC. Assessments were over 52 weeks for MRTC levels, EDSS, MSIS-29, brain MRI and relapses. The 30-45E6 dose was the most effective with reductions in MRTC ranging from 92.4% at week 5 to 64.8% at week 52. The reduction in relapses compared to baseline for the M-ITT and evaluable per-protocol analyses were 63.5%, and 85.0% at week 52. The MRI lesions were stable while there was an improvement trend in the EDSS and MSIS-29 physical subscore following the second injection. Adverse events were mild to moderate in intensity with mild injection site reactions occurring with increasing dosage. The mid-dose was selected for further clinical development studies because of the rapid depletion of peripheral blood MRTC and a trend for improvements in clinical outcomes following immunization.

100 项与 Imilecleucel-T 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10472	-	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
脑萎缩	临床2期	美国	Opexa Therapeutics, Inc.	2012-08-01
脑萎缩	临床2期	加拿大	Opexa Therapeutics, Inc.	2012-08-01
疾病进展	临床2期	美国	Opexa Therapeutics, Inc.	2012-08-01
疾病进展	临床2期	加拿大	Opexa Therapeutics, Inc.	2012-08-01
继发进展型多发性硬化	临床2期	加拿大	Opexa Therapeutics, Inc.	2012-08-01
临床孤立综合征	临床2期	美国	Opexa Therapeutics, Inc.	2007-11-01
子宫颈原位癌	临床2期	美国	Opexa Therapeutics, Inc.	2006-05-01
复发-缓解型多发性硬化	临床2期	美国	Opexa Therapeutics, Inc.	2006-05-01
继发进展型多发性硬化	临床1期	美国	Opexa Therapeutics, Inc.	2012-08-01