THERAPY DOSSIER · th-2f45375b1a91

Protected graft copolymer-formulated fibroblast growth factor 4 (PF4) and fibroblast growth factor 7 (PF7), alone or combined (PF4/7)

Biologic · Fibroblast growth factor receptor 2 agonist (AGONIST, direct_interaction true, disease_efficacy true; ChEMBL mec_id 969). Palifermin is recombinant human keratinocyte growth factor (KGF/FGF7); this resolves the FGF7 component ONLY, not FGF4 and not the protected graft copolymer formulation. ATC V03AF08. Protein, parenteral.

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Evidence & regulatory context

Mechanism: Fibroblast growth factor receptor 2 agonist (AGONIST, direct_interaction true, disease_efficacy true; ChEMBL mec_id 969). Palifermin is recombinant human keratinocyte growth factor (KGF/FGF7); this resolves the FGF7 component ONLY, not FGF4 and not the protected graft copolymer formulation. ATC V03AF08. Protein, parenteral.
Target: CHEMBL4142
Injury models: Radiation · Burn
Reported indication: Not recorded
First approval: 2005
Development stage: Not recorded
ChEMBL record: CHEMBL1201821 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Kepivance; Palifermin; Palifermina; Palifermine
Note: Not recorded

Clinical trials 7

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT05139004 ↗Injury indicationPHASE1active not recruiting

Trial title not recorded

Acute Lymphoblastic Leukemia · Acute Myeloid Leukemia · Myelodysplastic Syndrome

Enrolment: 7 · Results not recorded

NCT00629798 ↗PHASE2completed

Trial title not recorded

Acute Myeloid Leukemia · Advanced Myelodysplastic Syndromes

Enrolment: 64 · Results not recorded

NCT01200329 ↗PHASE2completed

Trial title not recorded

Lymphoma

Enrolment: 81 · Results not recorded

NCT07582172 ↗PHASE2not yet recruiting

Trial title not recorded

Refractory Acute Myeloid Leukemia · Myelodysplastic Syndrome

Enrolment: 35 · Results not recorded

NCT00540332 ↗PHASE1/PHASE2withdrawn

Trial title not recorded

Head and Neck Cancer

Enrolment: 0 · Results not recorded

NCT00881556 ↗EARLY_PHASE1terminated

Trial title not recorded

Epidermolysis Bullosa

Enrolment: 3 · Results not recorded

NCT00610818 ↗Phase not recordedterminated

Trial title not recorded

Skin Rash

Enrolment: 7 · Results not recorded

Preclinical evidence 4

1 studies reported at therapy level; 4 evidence entries itemised.

PMID 28207794 ↗2017Reported benefit

Protected graft copolymer-formulated fibroblast growth factors mitigate the lethality of partial body irradiation injury

MouseRadiationC57BL/6J for the irradiation studies; CD1 for the pharmacokinetic studiesmale C57BL/6J for the irradiation studies; female CD1 for the pharmacokinetic studiesn = n = 30 per group across eight groups in the survival study;…Subcutaneous at 10 ml/kg; amifostine intraperitonealPF4 3 mg/kg; PF7 3 mg/kg; PF4/7 combination 1.5 mg/kg each;…First dose 24 h after partial body irradiation; amifostine positive control 30…

Model: Partial body irradiation targeting the gastrointestinal tract, 15.7 Gy (LD50/30) to the lower body with head, forelimbs and thorax shielded, using a 6 MV LINAC photon source at up to 100 cGy/min

PF4 or PF7 given subcutaneously from 24 h after 15.7 Gy partial body irradiation produced 93.3 percent survival versus 60 percent in irradiated controls (p<0.0023). PF4 and PF7 were not significantly different from the amifostine positive control, and PF7 gave the most pronounced mitigation. Unform…

Extraction: extract · Supplied extraction confidence: 0.92. Machine-extracted fields require source verification.

PMID 17869665 ↗2007

Effect of recombinant human keratinocyte growth factor (rHuKGF, Palifermin) on radiation-induced mouse urinary bladder dysfunction

MouseRadiation

Extraction: mesh. Machine-extracted fields require source verification.

PMID 12140734 ↗2002

Non-viral liposomal keratinocyte growth factor (KGF) cDNA gene transfer improves dermal and epidermal regeneration through stimulation of epithelial and mesenchymal factor

RatBurn

Extraction: mesh. Machine-extracted fields require source verification.

PMID 12139711 ↗2002

The effect of keratinocyte growth factor on healing of manifest radiation ulcers in mouse tongue epithelium

MouseRadiation

Extraction: mesh. Machine-extracted fields require source verification.

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Protected graft copolymer-formulated fibroblast growth factor 4 (PF4) and fibroblast growth factor 7 (PF7), alone or combined (PF4/7)