Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)(Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary))

概要

基本信息

药物类型

生长因子

别名

FGF-2

靶点

FGFR1 x FGFR2

作用机制

FGFR1刺激剂(成纤维细胞生长因子受体-1刺激剂)、FGFR2刺激剂(成纤维细胞生长因子受体-2刺激剂)

治疗领域

耳鼻咽喉疾病其他疾病口颌疾病

在研适应症-

非在研适应症

根分叉部缺损牙龈退缩牙周炎+ [1]

原研机构-

在研机构-

非在研机构

SVS Institute of Dental Sciences

NYU Langone Health

Massachusetts Eye & Ear Infirmary, Inc.

最高研发阶段无进展临床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

2

项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的临床试验

NCT04960384 / Recruiting临床2期IIT

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

This study is a double blinded, placebo-controlled phase II study evaluating the efficacy of FGF-2 for the treatment of chronic non-healing tympanic membrane perforations (TMP). The documentation of TM closure will be the main efficacy outcome measure. Pretreatment photographs will document the area of the TM perforation and allow measurement of surface areas of the TMP for comparison of pre- and post-treatment. The study will be divided into two phases, the Randomized Treatment phase (part A), and the Unblinded Crossover phase (part B). In part A of the study, subjects will be randomized 1:1 (using simple randomization) to receive FGF-2 or placebo treatment up to 3 treatments. Subjects that fail three study treatments will move on to part B of the study. Subjects who received placebo in part A and failed three placebo treatments will crossover to receive unblinded FGF-2 for up to 3 treatments. Subjects who received FGF-2 in part A and failed three experimental treatments will not have additional FGF-2 treatment, and will move on to study follow up.

开始日期2022-05-27

申办/合作机构

NYU Langone Health

NCT02307916 / Completed临床2期IIT

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.

开始日期2016-10-01

申办/合作机构

Massachusetts Eye & Ear Infirmary, Inc.

[+1]

100 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的临床结果

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100 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的转化医学

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100 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的专利（医药）

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244

项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的文献（医药）

2024-10-01·Journal of Managed Care & Specialty Pharmacy

Utilization and patient characteristics for the trastuzumab reference and biosimilars, and other human epidermal growth factor receptor 2 inhibitors in the United States

Article

作者: Lockhart, Catherine M. ; Lin, Nancy D. ; Daniels, Kimberly ; Pawloski, Pamala A. ; Marshall, James ; Jamal-Allial, Aziza ; McDermott, Cara L. ; McMahill-Walraven, Cheryl N. ; Mai, Xiaodan ; Ko, Jenice S. ; Djibo, Djeneba Audrey ; Mendelsohn, Aaron B.

BACKGROUNDTrastuzumab is an antihuman epidermal growth factor receptor 2 monoclonal antibody used to treat breast and other cancers. Trastuzumab biosimilars were approved in the United States beginning in 2017. Utilization information on these biosimilars is limited.OBJECTIVETo examine utilization patterns and characteristics of patients treated with trastuzumab (biosimilars and reference) and other human epidermal growth factor receptor 2 products.METHODSWe evaluated health care claims data from the Biologics and Biosimilars Collective Intelligence Consortium distributed research network, representing a large, geographically diverse US population of commercially insured individuals. We queried 4 distributed research network health plan partners to capture product usage data and patient information from October 1, 2016, to October 31, 2022. Patients were required to be continuously enrolled in their health plan for at least 365 days before their first observed trastuzumab utilization date in this study period. Data were aggregated across data partners.RESULTSMore than 16 million eligible health plan members representing more than 31 million person-years of data were evaluated. We identified 5,984 incident treatment episodes; 3,878 (64.8%) episodes were with the reference trastuzumab. The mean ages were consistent across trastuzumab products (60.2 to 65.1 years) and at least 80% of the episodes were among female patients. The mean comorbidity index score was 1.2 (SD = 1.9) among users of the reference vs the biosimilars (range 1.2-2.5). Other clinical characteristics (eg, diabetes, hypertension) were comparable across products. The proportion of total incident episodes of the reference trastuzumab decreased substantially over time (96% in 2016 vs 28% in 2021) as utilization of the biosimilars increased (eg, use of trastuzumab-anns increased from 2% [2019] to 36% [2021]). Similar utilization trends were seen among patients with and without metastatic breast cancer.CONCLUSIONSTrastuzumab biosimilars utilization has grown since their introduction to the US market. Exploration of these biosimilars' comparative effectiveness and safety to their reference product is warranted.

2024-10-01·Heliyon

Case report: Successful treatment of advanced urothelial carcinoma with trophoblastic differentiation using Tislelizumab and Disitamab vedotin

Article

作者: Wu, Zheng ; Zhou, Yujuan ; Liu, Lin ; Chen, Han ; Han, Chen ; Han, Yaqian

BackgroundUrothelial carcinoma with trophoblastic differentiation represents an uncommon and aggressive malignancy for which there is currently no established standard treatment. Systemic chemotherapy as the main treatment has limited efficacy. However, recent research has demonstrated significant improvements in patient survival with the use of immune checkpoint inhibitors and antibody-drug conjugates. To our knowledge, this case represents the first successful application of an immune checkpoint inhibitor (Tislelizumab) combined with human epidermal growth factor receptor 2-targeting antibody-drug conjugate (Disitamab vedotin) in the treatment of advanced urothelial carcinoma with trophoblastic differentiation.Case reportWe describe the case of a 36-year-old male patient diagnosed with urothelial carcinoma with trophoblastic differentiation, showing high expression of programmed death-ligand 1. Tumor progression occurred after six cycles of Tislelizumab combined with chemotherapy (gemcitabine and cisplatin) followed by five cycles of Tislelizumab monotherapy. Re-biopsy confirmed metastatic urothelial carcinoma with trophoblastic differentiation, now with epidermal growth factor receptor 2 overexpression. Treatment with Disitamab vedotin in combination with Tislelizumab resulted in a biochemical and imaging complete response, leading to an overall survival exceeding 24 months. Notably, no grade 3 or 4 adverse events were observed during treatment.DiscussionThe prognosis of advanced urothelial carcinoma with trophoblastic differentiation is unfavorable, and the available therapeutic options are limited. Combining Tislelizumab with Disitamab vedotin presents a promising anti-tumor strategy that warrants further investigation.

2024-09-01·Archives of Oral Biology

The role of fibroblast growth factor-2 in modulating the differentiation of periodontal ligament and alveolar bone-derived stem cells

Article

作者: Xu, Jinping ; Sexton, Benjamin ; Dal-Fabbro, Renan ; Bottino, Marco C ; Han, Yuanyuan ; Kaigler, Darnell

OBJECTIVEThis study examined how range concentrations of Fibroblast Growth Factor-2 (FGF-2) influence the differentiation and activity of human-derived periodontal ligament (hPDLSCs) and alveolar bone-derived stem cells (haBMSCs).DESIGNhPDLSCs and haBMSCs were cultured with varying concentrations of FGF-2 (0, 1, 2.5, 5, 10, 20 ng/mL) and monitored for osteogenic differentiation through alkaline phosphatase (ALP) activity and quantification of gene expression (qRT-PCR) for osteogenesis markers. Additionally, alizarin red staining and a hydroxyproline colorimetric assay evaluated and quantified osteogenic matrix mineralization and collagen deposition. Statistical analyses were performed using one-way ANOVA or two-way ANOVA for multiple comparisons between groups.RESULTSAt low FGF-2 concentrations, hPDLSCs differentiated toward an osteogenic lineage, whereas higher concentrations of FGF-2 inhibited osteogenesis and promoted fibroblastic differentiation. The effect of FGF-2 at the lowest concentration tested (1 ng/mL) led to significantly higher ALP activity than osteogenically induced positive controls at early time points and equivalent RUNX2 expression at early and later time points. FGF-2 supplementation of haBMSC cultures was sufficient, at all concentrations, to increase ALP activity at an earlier time point. Mineralization of haBMSC cultures increased significantly within 5-20 ng/mL FGF-2 concentrations under basal growth media conditions (α-minimal essential medium supplemented with 15 % fetal bovine serum and 1 % penicillin/streptomycin).CONCLUSIONSFGF-2 has a dual capacity in promoting osteogenic and fibroblastic differentiation within hPDLSCs contingent upon the dosage and timing of administration, alongside supporting osteogenic differentiation in haBMSCs. These findings underscore the need for precision growth factors dosing when considering the design of biomaterials for periodontal regeneration.

100 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的药物交易

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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
根分叉部缺损	临床2期	印度	SVS Institute of Dental Sciences	2019-05-01
牙龈退缩	临床2期	印度	SVS Institute of Dental Sciences	2019-05-01
牙周炎	临床2期	印度	SVS Institute of Dental Sciences	2019-05-01
鼓膜穿孔	临床2期	美国	Massachusetts Eye & Ear Infirmary, Inc.	2016-10-01

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临床结果

适应症

分期

评价

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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


NCT02307916 (CTgov)	临床2期	鼓膜穿孔	57	FGF-2 (FGF-2)	蓋齋構襯選鏇鬱窪鹹製(膚鏇壓選積餘顧壓餘繭) = 願夢夢觸窪餘鹹遞壓淵願艱醖憲餘窪構鑰鑰簾 (繭構壓艱鏇艱構衊鬱鹹, 壓憲膚夢顧範鑰製遞齋 ~ 簾願積願憲繭廠鑰網艱) 更多	-	2020-06-11
				Placebo (Placebo)	蓋齋構襯選鏇鬱窪鹹製(膚鏇壓選積餘顧壓餘繭) = 選願壓壓艱膚襯艱積壓願艱醖憲餘窪構鑰鑰簾 (繭構壓艱鏇艱構衊鬱鹹, 鏇遞夢遞壓遞窪廠選憲 ~ 襯遞襯鏇簾夢醖壓構構) 更多
ARVO2012	N/A	-	-	TGFβ1	壓鬱窪願夢憲衊鏇遞壓(選鏇願餘網鹹憲構製齋) = 鬱鬱鏇壓簾積願願繭衊餘膚積範淵夢憲醖鹹蓋 (築醖壓艱襯選願憲範襯 ) 更多	-	2012-03-01
				FGF2	壓鬱窪願夢憲衊鏇遞壓(選鏇願餘網鹹憲構製齋) = 製願夢築簾簾網範襯壓餘膚積範淵夢憲醖鹹蓋 (築醖壓艱襯選願憲範襯 ) 更多