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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241

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

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 ; Han, Yaqian ; Chen, Han ; Zhou, Yujuan ; Han, Chen ; Liu, Lin

Background:

Urothelial 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 report:

We 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.

Discussion:

The 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.

2024-10-01·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: Jamal-Allial, Aziza ; McDermott, Cara L. ; Mai, Xiaodan ; Djibo, Djeneba Audrey ; Lockhart, Catherine M. ; Marshall, James ; Ko, Jenice S. ; McMahill-Walraven, Cheryl N. ; Pawloski, Pamala A. ; Daniels, Kimberly ; Mendelsohn, Aaron B. ; Lin, Nancy D.

BACKGROUND:

Trastuzumab 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.

OBJECTIVE:

To examine utilization patterns and characteristics of patients treated with trastuzumab (biosimilars and reference) and other human epidermal growth factor receptor 2 products.

METHODS:

We 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.

RESULTS:

More 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.

CONCLUSIONS:

Trastuzumab 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.

2024-09-01·AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Article

作者: Ewbank, Hallum ; Po, Sunny S ; Po, Sunny S. ; Dasari, Tarun W. ; Nagai, Michiaki ; Dasari, Tarun W

Objectives::

Cardiotoxic chemotherapy is used to treat malignancies such as breast cancer and lymphoma. These treatments predispose patients to cardiotoxicity that can lead to cancer treatment-related cardiac dysfunction (CTRCD). The use of high doses of anthracyclines or in combination with human epidermal growth factor receptor 2 antagonists is associated with a progressively higher risk of CTRCD. CTRCD is preceded by increased activation of the sympathetic nervous system and abnormal left ventricular mechanical deformation as measured by abnormal global longitudinal strain (GLS). Low-level tragus stimulation (LLTS) is a new, safe, noninvasive technique that offers great potential to reduce increased sympathetic activation and improve GLS. Here, we describe a study method to examine the effects of LLTS on autonomic balance and cardiac function in breast cancer or lymphoma patients treated with anthracyclines.

Methods::

A first-in-human pilot, randomized, double-blind feasibility study will evaluate 104 patients (age >50 y) with breast cancer or lymphoma who receive anthracyclines with one additional CTRCD risk factor. Patients undergo 2 weeks of LLTS daily (1 h/d). Autonomic balance will be measured using heart rate variability metrics. Strain imaging using GLS will be performed pre and post-LLTS. Endothelial inflammation and oxidative stress measures will be performed using in vitro assays at baseline and after 2 weeks.

Conclusion::

We hypothesize that LLTS stabilizes sympathovagal imbalance and improves cardiac performance in anthracycline-treated patients with breast cancer or lymphoma.

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
鼓膜穿孔	临床2期	美国	Massachusetts Eye & Ear Infirmary, Inc.	2016-10-01
根分叉部缺损	临床1期	印度	SVS Institute of Dental Sciences	2019-05-01
牙龈退缩	临床1期	印度	SVS Institute of Dental Sciences	2019-05-01
牙周炎	临床1期	印度	SVS Institute of Dental Sciences	2019-05-01

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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)	鬱鑰衊網醖顧鬱膚範夢(醖壓襯網艱襯積糧願觸) = 簾願糧繭顧鬱鏇餘憲淵範糧廠醖淵觸範窪範夢 (簾顧壓糧築醖衊淵鑰鏇, 窪窪選築膚醖鑰壓壓鬱 ~ 鬱醖遞範製構鏇遞願窪) 更多	-	2020-06-11
				Placebo (Placebo)	鬱鑰衊網醖顧鬱膚範夢(醖壓襯網艱襯積糧願觸) = 艱鑰鹹醖簾鏇憲齋繭鏇範糧廠醖淵觸範窪範夢 (簾顧壓糧築醖衊淵鑰鏇, 膚艱廠齋觸窪築衊鏇餘 ~ 餘繭構糧夢襯遞糧糧襯) 更多
ARVO2012	N/A	-	-	TGFβ1	鏇鬱鏇選鬱積築顧積遞(憲繭壓築蓋淵餘蓋鏇淵) = 築築廠淵願網鹽獵蓋齋網繭淵獵網鹽齋簾鏇蓋 (製繭壓鬱膚鑰壓遞簾簾 ) 更多	-	2012-03-01
				FGF2	鏇鬱鏇選鬱積築顧積遞(憲繭壓築蓋淵餘蓋鏇淵) = 構淵鬱淵淵構鑰遞範繭網繭淵獵網鹽齋簾鏇蓋 (製繭壓鬱膚鑰壓遞簾簾 ) 更多