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 Ulcer

Inactive Indication

Alveolar Bone LossDiabetic foot ulcerPeriodontal Attachment Loss

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 Ulcer

Regulation-

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Gene Sequence

Sequence Code 507553

Source: *****

Rapid and scar-free healing of burn wounds is an urgent clinical issue. Basic fibroblast growth factor (bFGF) has been proven to promote the healing of burn wounds by accelerating ECM remodeling and angiogenesis. However, exudates from burn wounds can accelerate bFGF degradation, thereby affecting its bioactivity. This study proposes an effective protection strategy for bFGF that involves encapsulating bFGF in nanoliposomes (bFGF-NLip) and then incorporating bFGF-NLip into a bovine serum albumin (BSA) hydrogel. This hybrid hydrogel system (bFGF-NLip@B) could maintain the activity of bFGF, achieve sustained release, and allow phospholipids and cholesterol to penetrate the skin, thereby enabling bFGF to function in the dermis. The experimental results showed that the hydrogel was injectable with good mechanical properties and biocompatibility. In a mouse scald wound model, owing to the sustained release of bFGF and skin permeation function of the nanoliposomes, the hydrogel promoted granulation formation, collagen deposition, vascular regeneration, and re-epithelialisation, ultimately accelerating wound healing. In addition, the hydrogel effectively inhibited scar formation. This system provides novel insights into the delivery of bFGF and scar-free healing of burn wounds.

01 Dec 2024·Journal of Controlled Release

Drug conjugates crosslinked bioresponsive hydrogel for combination therapy of diabetic wound

Article

Author: Zheng, Manhui ; Wu, Jiang ; Song, Wenxiang ; Zhang, Miao ; Lin, Hanxuan ; Huang, Yueping ; Huang, Peipei ; He, Huacheng

Basic fibroblast growth factor (bFGF) has proved to be effective for wound healing, yet its effectiveness is extremely retarded in diabetic wounds due to the severe oxidative stress in wound beds. To solve this issue, herein a novel combination therapy of bFGF and N-acetylcysteine (NAC, antioxidant) was devised for improved diabetic wound repair. To avoid rapid loss of both drugs in the wound beds, a bioresponsive hydrogel (bFGF-HSPP-NAC) was engineered by incorporating bFGF and NAC into polymer-drug conjugates (HSPP) via thiol-disulfide exchange reactions. In response to oxidative stress (e.g., reactive oxygen species), the disulfide bonds (SS) within the hydrogel are broken into thiol groups (-S-H), thereby promoting hydrogel degradation and enabling controlled drug release. Initially, NAC is released to scavenge free radicals and ameliorate oxidative damage. Subsequently, bFGF is released to expedite tissue regeneration. This combinatorial strategy is tailored to the specific characteristics of the wound microenvironment at various stages of diabetic wound healing, thereby achieving therapeutic efficacy. The results indicate that the bFGF-HSPP-NAC hydrogel markedly enhances re-epithelialization, collagen deposition, hair follicle regeneration, and neovascularization. In conclusion, the bioresponsive bFGF-HSPP-NAC hydrogel demonstrates significant potential for application in combinatorial therapeutic approaches for diabetic wound healing.

01 Dec 2024·Contemporary Clinical Trials Communications

Concomitant heparin use promotes skin graft donor site healing by basic fibroblast growth factor: A pilot prospective randomized controlled study

Article

Author: Ogawa, Takenori ; Kohyama, Keishi ; Suzuki, Kodai ; Kato, Hisakazu ; Miyake, Takahito ; Okada, Hideshi ; Okuda, Hiroshi ; Tomita, Hiroyuki ; Yasue, Yuji ; Kamidani, Ryo ; Shibata, Hirofumi ; Ishihara, Takuma

Owing to its mitogenic and angiogenic characteristics, the use of basic fibroblast growth factor (bFGF) to promote wound healing has been investigated. However, its clinical efficacy has fallen short of expectations due to its instability. Heparin has been reported to stabilize bFGF. Therefore, we hypothesized that the combination of these agents would more effectively promote wound healing than bFGF alone; a single-center, two-arm parallel, single-blind, and a prospective randomized controlled pilot study was therefore performed involving 12 patients who underwent split-thickness skin graft harvesting. To ensure a feasible clinical treatment model, commercially available agents were used. The patients were randomly assigned to either the control group treated with bFGF (n = 6) or the intervention group treated with bFGF and heparin (n = 6) in a 1:1 ratio. The wound area and the wound area variation was assessed each week postoperatively, as was the number of days required for epithelialization. As a supplementary analysis, the least-squares means were calculated using a linear mixed-effects model. The results of this study indicate that the combination of bFGF and heparin may more effectively promote wound healing than bFGF alone, consistent with our hypothesis. A multicenter trial based on these data is ongoing.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic foot ulcer	Preclinical	CZ	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
Diabetic foot ulcer	Preclinical	HU	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)	xjlmiplzut(nbiehjmvkz) = otxpacvzfj fxapvgblus (bgdiasddjt, gbhlwhlzlz - evbzdraish) View more	-	05 Aug 2014
				placebo (Placebo)	xjlmiplzut(nbiehjmvkz) = hwzpcdmypz fxapvgblus (bgdiasddjt, hftvgmqchs - cjjerutabn) View more
NCT01217463 (TRANS-South, CTgov)	Phase 3	Diabetic foot ulcer	201	Trafermin 0.01% spray (Trafermin 0.01% Spray)	bigazbelfw(zomgvtuxfo) = hqddtxxbwg amdlwcdemo (ehktdkfzhv, vpcmcflkcs - oeavyirnsh)	-	05 Aug 2014
				Trafermin 0.01% spray (Matching Placebo Spray)	bigazbelfw(zomgvtuxfo) = ytbzsrvixd amdlwcdemo (ehktdkfzhv, uwjgidzqwy - npmzsyuqgn)
ARVO2003	Not Applicable	Ganglion Cysts	-	Adenosine 10 µM	bxtxxgjpam(wwvaalcquv) = cljudivtwu fuwkdpudaq (kvsqjhrkof )	-	01 May 2003
				Adenosine 100 µM	bxtxxgjpam(wwvaalcquv) = qwfpjwyioo fuwkdpudaq (kvsqjhrkof )
ARVO2002	Not Applicable	Neovascularization, Pathologic	18	Medpor(R) soaked with bFGF	hbmytmffai(uitbowpdkt) = mxvxqkwxxa avkentfndu (wyxcxavhid )	Positive	01 Dec 2002
				Basic Fibroblast Growth Factor	hbmytmffai(uitbowpdkt) = bfltizxcvc avkentfndu (wyxcxavhid )