Delving into the Latest Updates on Trafermin with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

Fiblast Spray, REGROTH Dental Kit, RH-BFGF

+ [11]

Target

FGFRs

Mechanism

FGFRs stimulants(Fibroblast growth factor receptors stimulants)

Therapeutic Areas

Mouth and Tooth DiseasesSkin and Musculoskeletal Diseases

Active Indication

PeriodontitisPressure UlcerSkin Ulcer

Inactive Indication

Alveolar Bone LossDiabetic FootDiabetic foot ulcer+ [1]

Originator Organization

Kaken Pharmaceutical Co., Ltd.

Active Organization

Kaken Pharmaceutical Co., Ltd.

Inactive Organization

Olympus Biotech Corp.

Drug Highest PhaseApproved

First Approval Date

JP (04 Apr 2001),

Pressure UlcerSkin Ulcer

Regulation-

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Gene Sequence

Sequence Code 507553

Source: *****

PURPOSETo compare surgical outcomes of regenerative treatment (RT) including basic fibroblast growth factor (bFGF) (Group-R) with the conventional method (Group-C) for patients with tympanic membrane perforation (TMP), both of whom underwent transcanal endoscopic ear surgery.METHODSThe study population of Group-R included 61 ears of 59 patients treated with RT-TMP in which TMP edges were disrupted mechanically and a gelatin sponge immersed in bFGF was inserted into the TMP. Fibrin glue was then dripped over the sponge. Group-C consisted of 13 patients who underwent conventional surgery before adopting the RT-TMP. Patients' characteristics and outcomes including TMP closure rates, and change in hearing level were evaluated three or more weeks after the surgery.RESULTSThe baseline characteristics including size of TMP were not significantly different between the two groups. Although Group-R had significantly shorter operating time than Group-C, the complete TMP closure rates were 69 % (9/13) and 85 % (52/61), respectively. Air-conduction hearing thresholds showed significant improvements, and analysis of variance showed that Group-R achieved significant interactions other than at 8 kHz, implying better improvement in cases with TMP closure. The air-bone gaps also improved at all frequencies in both groups. Specifically, at 4 kHz, there was a trend showing better improvement in Group-R.CONCLUSIONRT-TMP had a high TMP closure rate and good hearing improvement, with no significant differences compared with those of conventional surgery. This new therapy is simple and safe, and requires less operating time, and it could help improve the quality of life of patients with TMP.

02 Aug 2024·European Journal of Cardio-Thoracic Surgery

Promoting successful healing of artificial trachea by intratracheal administration of basic fibroblast growth factor

Article

Author: Ibi, Yumiko ; Yutaka, Yojiro ; Omori, Koichi ; Yoshizawa, Akihiro ; Kishimoto, Yo ; Fukui, Takamasa ; Hidaka, Yu ; Date, Hiroshi ; Hirata, Rieko ; Murata, Yoshitake

AbstractOBJECTIVESThis study evaluated the effect of intratracheal administration of basic fibroblast growth factor (bFGF) on tracheal healing following implantation of a novel layered polyglycolic acid (PGA) material to replace a critical-size defect in rat trachea.METHODSA critical-size defect in the rat cervical trachea was covered with PGA. Distilled water (DW) or 3.125, 6.25, 12.5 or 25 µg bFGF was administered into the trachea for 2 weeks (n = 6 for each of 5 groups). Regenerated areas of cilia, ciliary beat frequency and ciliary transport function (CTF) in the centre of the PGA were measured. To examine potential side effects of intratracheal administration of bFGF, the right lower lobe was pathologically evaluated.RESULTSAll rats survived during the study period. Histological examination showed ciliated epithelization on the PGA material after 2 weeks. Bronchoscopy revealed stenosis due to granulation following administration of high concentrations of bFGF (12.5 and 25 µg). Compared with the DW group, groups administered 3.125, 6.25, 12.5 and 25 µg bFGF had significantly larger areas of regenerated cilia (15.2%, 27.0%, 41.3%, 33.1% and 31.0%, respectively; P = 0.00143), improved ciliary beat frequency (7.10, 8.18, 10.10, 9.50 and 9.50 Hz, respectively), and improved CTS (6.40, 9.54, 16.89, 16.41 and 14.29 µm/sec, respectively). Pathological examination of the right lower lobe revealed pulmonary fibrosis and hyperplasia with high concentrations of bFGF (12.5 and 25 µg).CONCLUSIONSIntratracheal administration of bFGF effectively promoted tracheal regeneration at an optimal dose of 6.25 µg following implantation of an artificial trachea.

05 Jun 2024·ACS Applied Materials & Interfaces

Electrospray Nano-Micro Composite Sodium Alginate Microspheres with Shape-Adaptive, Antibacterial, and Angiogenic Abilities for Infected Wound Healing

Article

Author: Li, Zhenlu ; Liu, Yangyang ; Li, Ze ; Huang, Jinjian ; Song, Shurui ; Wang, Peige ; Li, Jiayang

Nonhealing infectious wounds, characterized by bacterial colonization, wound microenvironment destruction, and shape complexity, present an intractable problem in clinical practice. Inspired by LEGOs, building-block toys that can be assembled into desired shapes, we proposed the use of electrospray nano-micro composite sodium alginate (SA) microspheres with antibacterial and angiogenic properties to fill irregularly shaped wounds instantly. Specifically, porous poly(lactic-co-glycolic acid) (PLGA) microspheres (MSs) encapsulating basic fibroblast growth factor (bFGF) were produced by a water-in-oil-in-water double-emulsion method. Then, bFGF@MSs were blended with the SA solution containing ZIF-8 nanoparticles. The resultant solution was electrosprayed to obtain nano-micro composite microspheres (bFGF@MS/ZIF-8@SAMSs). The composite MSs' size could be regulated by PLGA MS mass proportion and electrospray voltage. Moreover, bFGF, a potent angiogenic agent, and ZIF-8, bactericidal nanoparticles, were found to release from bFGF@MS/ZIF-8@SAMSs in a controlled and sustainable manner, which promoted cell proliferation, migration, and tube formation and killed bacteria. Through experimentation on rat models, bFGF@MS/ZIF-8@SAMSs were revealed to adapt to wound shapes and accelerate infected wound healing because of the synergistic effects of antibacterial and angiogenic abilities. In summation, this study developed a feasible approach to prepare bioactive nano-micro MSs as building blocks that can fill irregularly shaped infected wounds and improve healing.

100 Deals associated with Trafermin

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External Link

KEGG	Wiki	ATC	Drug Bank
D03362	Trafermin	D03	DB06244

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Periodontitis	JP	Kaken Pharmaceutical Co., Ltd.	28 Sep 2016
Pressure Ulcer	JP	Kaken Pharmaceutical Co., Ltd.	04 Apr 2001
Skin Ulcer	JP	Kaken Pharmaceutical Co., Ltd.	04 Apr 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic Foot	Preclinical	CZ	Olympus Biotech Corp.	01 Nov 2010
Diabetic Foot	Preclinical	HU	Olympus Biotech Corp.	01 Nov 2010
Diabetic Foot	Preclinical	IT	Olympus Biotech Corp.	01 Nov 2010
Diabetic Foot	Preclinical	FR	Olympus Biotech Corp.	01 Nov 2010
Diabetic foot ulcer	Preclinical	CZ	Olympus Biotech Corp.	01 Nov 2010
Diabetic foot ulcer	Preclinical	HU	Olympus Biotech Corp.	01 Nov 2010
Diabetic foot ulcer	Preclinical	IT	Olympus Biotech Corp.	01 Nov 2010
Diabetic foot ulcer	Preclinical	FR	Olympus Biotech Corp.	01 Nov 2010
Alveolar Bone Loss	Preclinical	JP	Kaken Pharmaceutical Co., Ltd.	01 Aug 2008
Periodontal Attachment Loss	Preclinical	JP	Kaken Pharmaceutical Co., Ltd.	01 Aug 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01217476 (TRANS-North, CTgov)	Phase 3	Diabetic foot ulcer	207	Trafermin (Trafermin)	wptmdqagxc(pxuqhpimae) = unuzanhtku ayhrounzip (wocdlfrypc, fxxxjbsvlg - uxfgotnyir) View more	-	05 Aug 2014
				placebo (Placebo)	wptmdqagxc(pxuqhpimae) = pxgjpgiupo ayhrounzip (wocdlfrypc, kqjtfpykbh - pogilmodzu) View more
NCT01217463 (TRANS-South, CTgov)	Phase 3	Diabetic foot ulcer	201	Trafermin 0.01% spray (Trafermin 0.01% Spray)	xxqgswcgvg(oltafnnyvh) = fccxfbvlin iobethanqx (azogdtkfcn, xpvwapydod - uomagdazua)	-	05 Aug 2014
				Trafermin 0.01% spray (Matching Placebo Spray)	xxqgswcgvg(oltafnnyvh) = oldlapdlec iobethanqx (azogdtkfcn, ifnbyicnfn - foeixpipyj)
ARVO2003	Not Applicable	Ganglion Cysts	-	Adenosine 10 µM	eftuzjdddy(ifnmseyror) = asfcxgpbuy gdigqhjfrq (auberrcqkr )	-	01 May 2003
				Adenosine 100 µM	eftuzjdddy(ifnmseyror) = jqvekidpgp gdigqhjfrq (auberrcqkr )
ARVO2002	Not Applicable	Neovascularization, Pathologic	18	Medpor(R) soaked with bFGF	ppnzukquhu(nfmwzsuvmu) = hqayevgduo fbjialopti (pvuylswydn )	Positive	01 Dec 2002
				Basic Fibroblast Growth Factor	ppnzukquhu(nfmwzsuvmu) = hmsnimisec fbjialopti (pvuylswydn )