A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of clinical efficacy are promising.
The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

开始日期2013-09-01

申办/合作机构

Neovacs SA

EUCTR2010-019996-32-CZ / Not yet recruiting临床2期

A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease

开始日期2011-02-11

申办/合作机构

Neovacs SA

NCT01291810 / Completed临床2期

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.
The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

开始日期2011-02-01

申办/合作机构

Neovacs SA

100 项与 Tumour necrosis factor alpha kinoid(Neovacs) 相关的临床结果

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100 项与 Tumour necrosis factor alpha kinoid(Neovacs) 相关的转化医学

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100 项与 Tumour necrosis factor alpha kinoid(Neovacs) 相关的专利（医药）

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140

项与 Tumour necrosis factor alpha kinoid(Neovacs) 相关的文献（医药）

2024-09-01·European journal of ophthalmology

Myopia control efficacy of peripheral defocus soft contact lenses in children and adolescents: A meta-analysis

Article

作者: Fan, Haobo ; Zhang, Xuemin ; Zhang, Renwei ; Zhong, Qiao ; Li, Bingqian ; Liu, Meng ; Wei, Qiumei ; Xie, Airui ; Li, Shilin

Objectives:

To evaluate the effect of peripheral defocus soft contact lenses (PDSCLs) on controlling myopia progression in children and adolescents, and to compare it with orthokeratology (Ortho-K) and single vision lenses (SVLs).

Methods:

We conducted a systematic search of PubMed, the Cochrane Library, Medline, CNKI, CBM, VIP, and WanFang Data databases for randomized controlled trials (RCTs) and cohort studies that investigated the effects of PDSCLs on myopia control in children and adolescents. The published languages were limited to English and Chinese. The risk bias tool provided by the Cochrane risk-of-bias tool and Newcastle-Ottawa Scale were used to assess the risk bias of included studies of RCTs and CTs. The published biases of included studies were assessed by Egger`s test.

Results:

We included 21 studies, comprising 13 RCTs and 8 cohort studies, with a total of 1337 participants in the PDSCLs group, 428 in the Ortho-K group, and 707 in the SVLs group. The meta-analysis indicated no significant difference between PDSCLs and Ortho-K in controlling the increase of diopter ( MD = 0.01, 95% CI: −0.06, 0.09; P = 0.69) and axial length ( MD = -0.01, 95% CI: −0.02, 0.00; P = 0.28). Compared with SVLs, PDSCLs had a better effect in controlling the increase of diopter ( MD = 0.23, 95% CI: 0.17, 0.28; P < 0.00001) and axial length ( MD = -0.11, 95% CI: −0.12, −0.09; P < 0.00001) in children and adolescents.

Conclusions:

Children and adolescents wearing PDSCLs can achieve better myopia control than those wearing SVLs, and their effect is comparable to that of Ortho-K.

2024-06-01·Contact lens & anterior eye : the journal of the British Contact Lens Association

The relationship between accommodative and binocular function with myopia progression in myopic children undergoing orthokeratology

Article

作者: Dong, Guangjing ; Ma, Wei ; Liu, Longqian ; Wang, Xue ; Zhu, Shenlin ; Song, Yutong ; Yang, Bi

PURPOSE:

To determine the relationship between changes in accommodative and binocular function with myopia progression in myopic children over a two-year follow-up period, and to determine when changes in visual functions stabilized after switching from spectacles to orthokeratology (Ortho-K).

METHODS:

This prospective, self-controlled study followed thirty-six participants (aged 8-14 years) for two years after they switched from spectacles to Ortho-K. Accommodative and binocular function were assessed prior to and 1, 3, 6, 12, 18 and 24 months after commencing Ortho-K. Measurements included accommodative amplitude, accommodative response, accommodative facility, accommodative convergence/accommodation (AC/A), ocular alignment, positive relative accommodation (PRA), negative relative accommodation (NRA), horizontal vergence range, reading ability and stereoacuity. Myopia progression was quantified by the change in axial length.

RESULTS:

Ocular alignment, monocular and binocular accommodative facility, and PRA stabilized after 1 month. The distance blur point in the convergence range, the distance break and recovery point in the divergence range, accommodative amplitude, calculated AC/A, stereoacuity and reading ability stabilized within 6 months. After two years of Ortho-K, NRA significantly increased (p = 0.044), while it showed no significant difference after one-year of lens wear (p = 0.49). The distance break point in the convergence range showed no significant difference (p = 0.20), but significantly decreased after one-year (p = 0.005). There were no significant correlations between the change in axial length with changes in accommodative or binocular function (p > 0.05).

CONCLUSION:

Accommodative and binocular function changed significantly after switching from spectacles to Ortho-K and most of the parameters stabilized within the first 6 months. There was no association between the change in accommodative or binocular function and myopia progression.

2024-06-01·Eye (London, England)

Comparison of the long-term effects of atropine in combination with Orthokeratology and defocus incorporated multiple segment lenses for myopia control in Chinese children and adolescents

Article

作者: Li, Xuewei ; Tang, Tao ; Li, Yan ; Wang, Kai ; Zhao, Mingwei ; Lu, Yuchang ; Zhao, Heng

PURPOSE:

The aim of this study was to evaluate the efficacy of Orthokeratology (Ortho-K), defocus incorporated multiple segment (DIMS) lens, combined Ortho-K/atropine, and combined DIMS/atropine for myopia control in children.

METHODS:

A retrospective study included 167 myopic children aged 6-14 years with a spherical equivalent refraction (SER) of -0.75 to -4.00 diopter treated with Ortho-K (OK, n = 41), combined Ortho-K/atropine (OKA, n = 43), DIMS (n = 41), or combined DIMS/atropine (DIMSA, n = 42). Axial length (AL) was measured at baseline and at 3, 6, 9 and 12 months. Axial elongation over time and between groups were analysed.

RESULTS:

After 12 months, the AL change was 0.20 ± 0.12 mm, 0.12 ± 0.14 mm, 0.22 ± 0.14 mm, and 0.15 ± 0.15 mm in the OK, OKA, DIMS, and DIMSA, respectively. There was no significant difference in AL change between OK and DIMS. OKA and DIMSA significantly slowed axial elongation compared to OK and DIMS monotherapy. After stratification by age, in the subgroup aged 6-10 years, there was significant difference in AL change between OKA and DIMS (p = 0.013), and no difference between other groups, while in the subgroup aged 10-14 years, the difference between OKA and DIMS became insignificant (p = 0.237), and the difference between OK and OKA, OK and DIMSA, DIMS and DIMSA became significant.

CONCLUSIONS:

Ortho-K and DIMS lenses show similar reductions in myopia progression among children with low initial myopia. Atropine can significantly improve the efficacy of myopia control of both Ortho-K and DIMS lenses, and this add-on effect is better in older children.

项与 Tumour necrosis factor alpha kinoid(Neovacs) 相关的新闻（医药）

2022-08-23

·BioSpace

Pharnext Announces a €2.5m Loan Agreement with Néovacs

PARIS, FRANCE / ACCESSWIRE / August 23, 2022 / Pharnext SA (FR0011191287-ALPHA) (the "Company"), an advanced late-clinical stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases with high unmet medical need, today announces the signing of a €2.5 million loan agreement (the "Loan") with Néovacs, a French biotechnology company listed on Euronext Growth Paris (ALNEV). The Loan will bear interest at 1% per month for a maximum duration of six months, i.e. until 21 February 2023 at the latest. The execution of the Loan is part of ongoing discussions between Pharnext and Néovacs to potentially enter into a broader financing agreement of Pharnext by Néovacs. In the event Pharnext and Néovacs reach such an agreement, Pharnext and Néovacs agreed that the Loan and the remuneration of the Loan (including then incurred interests and a structuring fee equal to 1% of the principal amount of the Loan) will be payable by way of a set off against financial instruments issued by Pharnext to Néovacs or one of its affiliates. If no agreement is reached among Pharnext and Néovacs, the Loan will be reimbursed by Pharnext at the Loan maturity, i.e. on 21 February 2023. About Pharnext Pharnext is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases that currently lack curative and/or disease-modifying treatments. Pharnext has two lead products in clinical development. PXT3003 completed an international Phase III trial with positive topline results for the treatment of Charcot-Marie-Tooth disease type 1A (‘CMT1A') and benefits from orphan drug status in Europe and the United States. An international pivotal Phase III study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing. PXT864 has generated encouraging Phase II results in Alzheimer's disease and will be advanced through partnerships. Both of Pharnext's lead assets originated from the Pleotherapy™ R&D approach. Pharnext draws the attention of investors to the financial and other risk factors detailed in its financial reports. More information can be found at . Pharnext is listed on the Euronext Growth Stock Exchange in Paris (ISIN code: FR0011191287). About Néovacs Néovacs is a French biotech company listed on Euronext Growth since 2010. The Company is focused on therapeutic vaccines targeting the treatment of autoimmune diseases. Its innovative technology named Kinoid™, patented until 2038, induces a polyclonal immune response, applicable in several indications. Néovacs has developed the IFNα KINOID to treat lupus in a clinical phase IIb study, the main study is now ended and the full results have been presented at the 13th international Lupus Congress 2019. The Company also carried out preclinical work on IL-4/ IL-13 Kinoid, another therapeutic vaccine for the treatment of allergies. The aim of this "KINOID approach" is to enable patients to better cope with a life-long treatment that would be more effective, well tolerated and unburdensome. For more information: éovacs.com/en/. Contacts - Pharnext Dr. David Horn Solomon Chief Executive Officer contact@pharnext.com +33 (0)1 41 09 22 30 Media Relations (International) Consilium Strategic Communications Mary-Jane Elliott Sukaina Virji Alexandra Harrison pharnext@consilium-comms.com Financial Communication (Europe) Actifin Ghislaine Gasparetto ggasparetto@actifin.fr +33 (0)6 21 10 49 24 Media Relations (France) Ulysse Communication Bruno Arabian barabian@ulysse-communication.com +33 (0)6 87 88 47 26 +33 (0)1 81 70 96 30 Contacts - Néovacs Investors Relations Financial Media Relations Jérôme Fabreguettes - Leib Déborah Schwartz neovacs@actus.fr dschwartz@actus.fr +33 (0)1 53 67 36 78 +33 (0)1 53 67 36 35 SOURCE: Pharnext View source version on accesswire.com:

合作孤儿药疫苗财报

2022-06-24

·靶点社

高价打造“新药王”？AbbVie如何迎接后修美乐时代

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。引言本周四，FDA发布的Federal Register信息显示，艾伯维（AbbVie）使用了一张儿科疾病优先审查凭证加速Rinvoq (upadactinib) 的审批流程。该药物在今年3月被FDA批准用于治疗对一种或多种肿瘤坏死因子 (TNF) 阻滞剂没有充分反应或不耐受的中度至重度活动性溃疡性结肠炎 (UC) 成人。 PRV优先审评凭证（PRV）制度是美国FDA为了鼓励制药企业开发针对某些热带疾病、罕见病、物质威胁医疗对策的药物所推行的一种福利制度。凡是按照成功开发出相关药物的制药商均可获得一张PRV。这张PRV可由药企自己使用，也可转手卖给其他制药公司，用于不符合优先审评的任何一款药物申请的优先审评，可将药品审查周期缩短4个月。FDA标准的审查过程大约需要10个月，但PRV可以将其缩短到6个月，这可以帮助制药商在营销药物方面抢占先机。艾伯维此次使用的这张PRV可能是在2020年以9500万美元从Eiger BioPharmaceuticals收购的，后者因早衰症药物Zokinvy （lonafarnib）获批而获得了PRV。 Rinvoq有无可能复制“药王”奇迹？Rinvoq是艾伯维开发的JAK1口服抑制剂，已在欧盟和美国获批包括克罗恩病、特应性皮炎、类风湿性关节炎、银屑病关节炎、溃疡性结肠炎和强直性脊柱炎等多个自身免疫疾病领域的适应症。艾伯维急于扩大Rinvoq的批准范围恐怕是因为其重磅产品修美乐（Humira）即将失去专利保护，这款在2021年给艾伯维带来了206.94亿美元净收入的“药王”产品即将面临大量生物仿制药的挑战。艾伯维希望Rinvoq和另一种新药Skyrizi来填补Humira专利到期后的空白。（相关阅读：艾伯维：首个用于克罗恩病的IL-23单抗获FDA批准）“Skyrizi和Rinvoq将在Humira的所有主要适应症以及特应性皮炎中实现商业化，”艾伯维董事长兼首席执行官Rick Gonzalez在公司年度报告电话会议上曾表示。“我们预计Skyrizi和Rinvoq的合并峰值销售额将超过Humira实现的峰值收入。”另外，周四的行动也并非艾伯维首次为Rinvoq使用优先审评凭证（PRV），Rinvoq 于2019年首次获批用于中度至重度类风湿性关节炎，据当时报道，艾伯维在申请中使用了PRV获得加速审查。而这份来自United Therapeutics儿童神经母细胞瘤新药Unituxin的PRV据悉花掉了艾伯维3.5亿美元。参考来源：[1] FDA[2] 过往公开新闻PR 稿对接：邮箱 acgt@pharnex.com靶点社靶点江湖 · 新药际会PR | 品牌推广 | 会议会展 | 行业咨询靶点社ACGT「靶点社，汇聚50,000+创新药英雄」

优先审批专利到期仿制药免疫疗法并购

100 项与 Tumour necrosis factor alpha kinoid(Neovacs) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	临床2期	比利时	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	格鲁吉亚	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	匈牙利	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	黎巴嫩	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	摩尔多瓦	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	北马其顿	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	波兰	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	俄罗斯	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	塞尔维亚	Neovacs SA	2013-09-01
类风湿关节炎	临床2期	乌克兰	Neovacs SA	2013-09-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2012	临床2期	TNF alpha	40	TNF-Kinoid 90 mcg	襯蓋鏇壓積艱衊艱網鹹(顧顧齋選衊願觸鑰夢膚) = 鬱糧衊製餘齋製獵鑰鹹廠積築顧網衊齋憲構窪 (餘糧糧簾窪夢襯蓋願範 ) 更多	-	2012-06-06
				Placebo	襯蓋鏇壓積艱衊艱網鹹(顧顧齋選衊願觸鑰夢膚) = 鏇製網壓觸網壓淵夢醖廠積築顧網衊齋憲構窪 (餘糧糧簾窪夢襯蓋願範 ) 更多