Delving into the Latest Updates on Palifermin with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

24-163 fibroblast growth factor 7 (human), Keratinocyte growth factor, KGF

+ [9]

Target

FGFR2

Mechanism

FGFR2 stimulants(Fibroblast growth factor receptor 2 stimulants)

Therapeutic Areas

Mouth and Tooth DiseasesNeoplasmsImmune System Diseases+ [2]

Active Indication

StomatitisLeukemiaMultiple Myeloma+ [1]

Inactive Indication

acute leukemiaAdvanced Head and Neck CarcinomaColonic Cancer+ [11]

Originator Organization

Sobi Analytics Ltd.

Active Organization

Swedish Orphan Biovitrum AB

Inactive Organization

Amgen, Inc.

Drug Highest PhaseApproved

First Approval Date

US (15 Dec 2004),

Stomatitis

Regulation-

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Gene Sequence

Sequence Code 31652

Source: *****

This phase I trial studies the side effects of human lysozyme goat milk in preventing graft versus host disease in patients with blood cancer undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can cause an immune response against the body's own normal cells (call graft versus host disease). The goat milk in the study is from goats that have been genetically engineered to produce human lysozyme in the milk. Human lysozyme is a natural enzyme found in human milk and acts as an antimicrobial. Lysozyme is key to the digestive health of breast-fed human infants, since it helps the growth of beneficial gut bacteria and reduces the growth of bacteria that causes diarrhea and intestinal disease. Giving human lysozyme goat milk may reduce the rate of graft versus host disease in blood cancer patients undergoing a donor stem cell transplant.

Start Date30 Apr 2021

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT03100877 / WithdrawnPhase 1/2IIT

Phase I-II Single Cycle Melphalan/Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) Followed by Maintenance in Patients With High-Risk Myeloma and/or Poor Response to Induction Therapy Within 12 Months of Diagnosis

This phase I/II trial studies the side effects and best dose of melphalan and total marrow irradiation and how well they work with autologous stem cell transplantation in treating patients with high-risk multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total marrow irradiation is a type of radiation therapy and a form of total body irradiation that may deliver focused radiation to the major marrow sites where cancer cells reside. Giving chemotherapy and total-body irradiation before a peripheral autologous blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Start Date01 Jan 2018

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT02356159 / Active, not recruitingPhase 1/2IIT

A Phase I/II Open Label, Dose Escalation Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

Background:
- In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given to a recipient. Sometimes the recipient s immune system destroys the donor s cells. Or donor immune cells attack the recipient s tissues, called graft-versus-host disease (GVHD). This is less likely when the recipient and donor have similar human leukocyte antigens (HLA). Researchers want to see if the drug palifermin improves the results of allogeneic SCT from HLA-matched unrelated donors.
Objective:
- To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and improve immune function after transplant.
Eligibility:
- Adults 18 years of age or older with blood or bone marrow cancer with no HLA-matched sibling, but with a possible HLA-matched donor.
Design:
* Participants will be screened with medical history, physical exam, and blood and urine tests. They will have scans and heart and lung exams.
* Before transplant, participants will:
* Have many tests and exams. These include blood tests throughout the study and bone marrow biopsy.
* Get a central line catheter if they do not have one.
* Have 1-3 rounds of chemotherapy.
* Take more tests to make sure they can have the transplant, including medical history, physical exam, and CT scan.
* Get palifermin by IV and more chemotherapy. They will get other drugs, some they will take for 6 months.
* Participants will get the SCT.
* After transplant, participants will:
* Be hospitalized at least 3-4 weeks.
* Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and biopsies.
* Stay near D.C. for 3 months.
* Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.

Start Date24 Sep 2015

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Palifermin

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100 Translational Medicine associated with Palifermin

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100 Patents (Medical) associated with Palifermin

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769

Literatures (Medical) associated with Palifermin

01 Jan 2025·IUBMB LIFE

KGF secreted from HSCs activates PAK4/BMI1, promotes HCC stemness through PI3K/AKT pathway

Article

Author: Chen, Dawei ; Li, Zhen ; Xie, Rongrong ; Wang, Wenchao ; Li, Qinghua ; Chen, Qiuyang

Abstract:

In our present study, we investigated the interaction between HSCs and HCC, also explored the molecular mechanism. Clinical samples were collected from HCC and adjacent tissue with different degree of liver fibrosis. HCC cells were co‐cultured with LX‐2 cell by Transwell system or cultured with conditioned medium (CM), which was collected from LX‐2. The tumor spheroid growth and colony formation analyses were performed to evaluate the cell stemness. Flow cytometry analysis was conducted on cell apoptosis after 5‐Fu treatment. Co‐immunoprecipitation assay confirmed the interaction between BMI1 and PAK4. Our results showed that BMI1 was highly expressed in HCC and was correlated with HCC liver fibrosis. Both co‐cultured with LX‐2 and cultured with CM promoted HCC stemness, also increased KGF level and BMI1 expression. KGF treatment had a similar effect with co‐culture with LX‐2 on HCC. BMI1 overexpression promoted HCC stemness and activated PI3K/AKT pathway, which was reversed by PI3K inhibition. PAK4 was activated by KGF, then phosphorylated S315 site and promoted protein stability of BMI1, therefore enhanced HCC stemness. BMI1 also had a promote effect on liver fibrosis. In summary, we found that KGF secreted by HSCs activated PAK4, which phosphorylated S315 and promoted protein stability of BMI1, and further promoted liver fibrosis and HCC stemness through the PI3K/AKT signaling pathway. Our present study deeply studied the interaction and mechanism between HSCs and HCC, which might provide a new insight for HCC therapy.

01 Jan 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Application of electrospinning and 3D-printing based bilayer composite scaffold in the skull base reconstruction during transnasal surgery

Article

Author: Liu, Xuezhe ; El-Newehy, Mohamed ; Zhang, Keyi ; EL-Newehy, Mohamed ; Zhu, Yiqian ; Cao, Lei ; Wang, Yongfei ; Abdulhameed, Meera Moydeen ; Mo, Xiumei

Skull base defects are a common complication after transsphenoidal endoscopic surgery, and their commonly used autologous tissue repair has limited clinical outcomes. Tissue-engineered scaffolds prepared by advanced techniques of electrostatic spinning and three-dimensional (3D) printing was an effective way to solve this problem. In this study, soft tissue scaffolds consisting of centripetal nanofiber mats and 3D-printed hard tissue scaffolds consisting of porous structures were prepared, respectively. And the two layers were combined to obtain bilayer composite scaffolds. The physicochemical characterization proved that the nanofiber mat prepared by polylactide-polycaprolactone (PLCL) electrospinning had a uniform centripetal nanofiber structure, and the loaded bFGF growth factor could achieve a slow release for 14 days and exert its bioactivity to promote the proliferation of fibroblasts. The porous scaffolds prepared with polycaprolactone (PCL), and hydroxyapatite (HA) 3D printing have a 300 μm macroporous structure with good biocompatibility. In vivo experiments results demonstrated that the bilayer composite scaffold could promote soft tissue repair of the skull base membrane through the centripetal nanofiber structure and slow-release of bFGF factor. It also played the role of promoting the regeneration of the skull base bone tissue. In addition, the centripetal nanofiber structure also had a promotional effect on the regeneration of skull base bone tissue.

01 Dec 2024·PLANT FOODS FOR HUMAN NUTRITION

Identification and Function Analysis of Novel Hypoglycemic and Antioxidant Peptides from Chickpea

Article

Author: Chen, Guoping ; Huang, Wenyi ; Yang, Na ; Chen, Yanlong ; Liang, Rongyao ; Li, Pei ; Cai, Kaiwei ; Xie, Zhiyong ; Liao, Qiongfeng ; Chen, Zihao

Chickpea is rich in protein and has been demonstrated to possess hypoglycaemic effects. However, the specific bioactive ingredients and mechanisms underlying their hypoglycaemic effects remain unclear. In this study, enzymatic hydrolysis and gel permeation chromatography were used to extract chickpea bioactive peptide (CBP) from chickpea protein. One of the products, CBP-75-3, was found to inhibit α-glucosidase (GAA) activity and significantly increase the viability of insulin resistant (IR) cells. Moreover, CBP-75-3 significantly increased the rate of glucose consumption and glycogen synthesis in IR-HepG2 cells. Moreover, CBP-75-3 decreased the levels of malondialdehyde and increased the levels of superoxide dismutase, glutathione, and glutathione peroxidase. Subsequently, 29 novel bioactive peptides in CBP-75-3 were identified by LC‒MS/MS, and the potential hypoglycaemic targets of these novel bioactive peptides were investigated using molecular docking. Based on the results, the residues of the novel bioactive peptides interact with GAA through hydrogen bonding (especially LLR, FH, RQLPR, KGF and NFQ by binding to the substrate binding pocket or the active centre of GAA), thereby inhibiting GAA activity and laying a foundation for its hypoglycaemic activity. In short, the novel bioactive peptides isolated and identified from chickpea can effectively exert hypoglycaemic effects and increase the antioxidant capacity of IR-HepG2 cells. This study reveals that CBP-75-3, a natural hypoglycaemic ingredient, has potential for applications in functional foods and provides a theoretical basis for the development and application of CBP in the future.

100 Deals associated with Palifermin

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External Link

KEGG	Wiki	ATC	Drug Bank
D05338	Palifermin	V03AF08	DB00039

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Stomatitis	US	Swedish Orphan Biovitrum AB	15 Dec 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Cancer	Phase 3	-	Amgen, Inc.	01 Aug 2005
Head and Neck Neoplasms	Phase 3	-	Amgen, Inc.	01 Aug 2005
Head and Neck Neoplasms	Phase 3	-	Swedish Orphan Biovitrum AB	01 Aug 2005
Squamous Cell Carcinoma	Phase 3	-	Amgen, Inc.	01 Aug 2005
Squamous Cell Carcinoma	Phase 3	-	Swedish Orphan Biovitrum AB	01 Aug 2005
Advanced Head and Neck Carcinoma	Phase 3	-	Amgen, Inc.	01 Jan 2005
Hematologic Neoplasms	Phase 3	-	Amgen, Inc.	15 Jul 2002
Hodgkin's Lymphoma	Phase 3	-	Amgen, Inc.	15 Jul 2002
Leukemia	Phase 3	-	Amgen, Inc.	15 Jul 2002
Mucositis	Phase 3	-	Amgen, Inc.	15 Jul 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	Graft vs Host Disease	-	Palifermin 540 µg/kg	jdmnusaxgh(okjdkdpvvt) = czvpuquiri kqusvcrhmq (uoqcmievrd ) View more	-	01 Feb 2023
				TMS (tacrolimus, methotrexate, sirolimus)	vsrzdvqghs(kkcnchcnxr) = twmlvzvjkf kwqbceqsik (qoyixbkqid ) View more
Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	-	-	Palifermin with Melphalan	ipccxkgwyj(nhdfgcjhzo) = No differences in 5-year survival were noted jktezhvuyd (apapneqrrh )	-	01 Feb 2023
				Melphalan
EBMT2020	Not Applicable	Lymphoma	73	Palifermin + BEAM conditioning	bqqaddqjde(jtuaavwmxs) = ccxetjgmwl ligyseiwth (tozaaipoju ) View more	-	29 Aug 2020
				BEAM conditioning	bqqaddqjde(jtuaavwmxs) = vkklzuzovn ligyseiwth (tozaaipoju ) View more
Tandem Meetings ASTCT and CIBMTR2020	Not Applicable	Hematopoietic stem cell transplantation	44	Palifermin	iglmlqjvym(sfaruptyzc) = apfimnudfg mifdzrnfyi (yoxburoevc, 7 - 16) View more	Negative	01 Mar 2020
NCT02037347 (CTgov)	Phase 1/2	Stevens-Johnson Syndrome	1	Palifermin	zbaiepsoce(jqrluyujxj) = grajxqmelx cqmhhinbig (amdvxhkoru, zarorlzudq - lslahlpblk) View more	-	30 Nov 2016
Tandem Meetings ASTCT and CIBMTR2016	Not Applicable	Mucositis \| Hematopoietic stem cell transplantation \| Stomatitis	-	Abbreviated Palifermin Schedule	jkeuxnnqoq(ekohokweee) = nlnszqkyhk dqtcnnsrtb (zhgrinycoo ) View more	-	01 Mar 2016
				No Palifermin	jtfcrqlmqi(nkssyygxvq) = wqnsqvtdjv lzaquodvrq (wjupfivahq ) View more
NCT00101582 (CTgov)	Phase 3	Mucositis \| Stomatitis \| Head and Neck Neoplasms ... View more	188	Radiotherapy+cisplatin chemotherapy (Placebo)	omsnoglzoq(lbupbjtkhh) = ubryulztgn miftwwbjmy (dcysofbvop, ydrjoqpszd - qqrfqioyez) View more	-	15 Sep 2014
				Radiotherapy+palifermin+cisplatin chemotherapy (Palifermin)	omsnoglzoq(lbupbjtkhh) = nmdxyrvsvl miftwwbjmy (dcysofbvop, gphcxsdxxp - sqtmjjpwlx) View more
NCT00109031 (CTgov)	Phase 3	Leukemia \| Stomatitis \| Lymphoma	47	Placebo+Etoposide+cyclophosphamide+palifermin (Palifermin 60 µg/kg for 3 Days)	kzqkqisvea(bscqsmhnpi) = mfqczrgyit ukwunqjtug (zscrhfspfv, dbflrudawu - qwygvmfrin) View more	-	15 Sep 2014
				Placebo+Etoposide+cyclophosphamide+palifermin (Palifermin 180 μg/kg on Day -1)	kzqkqisvea(bscqsmhnpi) = azpkcxqacp ukwunqjtug (zscrhfspfv, ybkjspncjt - hjfyjlhqyr) View more
ASCO2014	Not Applicable	Acute Lymphoblastic Leukemia \| Solid tumor	816	Palifermin	fpghdibono(tbmwymsguk) = eqtnurlxqf ztjmcvizdz (wqatkrnbnb ) View more	-	20 May 2014
				No Palifermin	fpghdibono(tbmwymsguk) = hcivqnffzn ztjmcvizdz (wqatkrnbnb ) View more
NCT00360971 (CTgov)	Phase 3	Radiation Injuries \| Pain \| Locally Advanced Malignant Neoplasm ... View more	21	placebo+cisplatin (Placebo)	hnyheaasha(kkhdbpzetm) = rnfotczeru chdvdbxsnv (tgjmrruwop, wiebcumilj - jvzpnodbur) View more	-	15 May 2014
				neck dissection+palifermin+cisplatin (Palifermin)	hnyheaasha(kkhdbpzetm) = yqovakxjip chdvdbxsnv (tgjmrruwop, xvshiqfdds - sojcdifqfq) View more