Delving into the Latest Updates on Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

FGF-2

Target

FGFR1 x FGFR2

Mechanism

FGFR1 stimulants(Fibroblast growth factor receptor 1 stimulants), FGFR2 stimulants(Fibroblast growth factor receptor 2 stimulants)

Therapeutic Areas

Otorhinolaryngologic DiseasesOther DiseasesMouth and Tooth Diseases

Active Indication-

Inactive Indication

Furcation DefectsGingival RecessionPeriodontitis+ [1]

Originator Organization-

Active Organization-

Inactive Organization

SVS Institute of Dental Sciences

NYU Langone Health

Massachusetts Eye & Ear Infirmary, Inc.

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

Login to view timeline

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.

Start Date27 May 2022

Sponsor / Collaborator

NYU Langone Health

NCT02307916 / CompletedPhase 2IIT

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.

Start Date01 Oct 2016

Sponsor / Collaborator

Massachusetts Eye & Ear Infirmary, Inc.

[+1]

100 Clinical Results associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

Login to view more data

100 Translational Medicine associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

Login to view more data

100 Patents (Medical) associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

Login to view more data

244

Literatures (Medical) associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

01 Oct 2024·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

Author: 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.

01 Oct 2024·Heliyon

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

Article

Author: 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.

01 Sep 2024·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

Author: 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 Deals associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Furcation Defects	Phase 2	IN	SVS Institute of Dental Sciences	01 May 2019
Gingival Recession	Phase 2	IN	SVS Institute of Dental Sciences	01 May 2019
Periodontitis	Phase 2	IN	SVS Institute of Dental Sciences	01 May 2019
Tympanic Membrane Perforation	Phase 2	US	Massachusetts Eye & Ear Infirmary, Inc.	01 Oct 2016

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02307916 (CTgov)	Phase 2	Tympanic Membrane Perforation	57	FGF-2 (FGF-2)	gettxoamof(faoesfkunz) = vvnyuaeovy vthgdmxdjl (pilvrnqbme, ejffyqexum - shimzfwmyg) View more	-	11 Jun 2020
				Placebo (Placebo)	gettxoamof(faoesfkunz) = ffxstjowuw vthgdmxdjl (pilvrnqbme, mempllbjir - fvvtukumea) View more
ARVO2012	Not Applicable	-	-	TGFβ1	gtbwvbahpd(vmqyazqtfl) = gvmojdmrof ulkmcglxsx (bmjhpjhvqz ) View more	-	01 Mar 2012
				FGF2	gtbwvbahpd(vmqyazqtfl) = vacnbzqmmh ulkmcglxsx (bmjhpjhvqz ) View more