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+ [8]

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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775

Literatures (Medical) associated with Palifermin

01 Dec 2023·Journal, genetic engineering & biotechnology

The potential role of the KFG and KITLG proteins in preventing granulosa cell apoptosis in Bubalus bubalis

Article

Author: Ali, Sher ; Panwar, Deepak ; Rawal, Leena

Abstract:

Background:

The dynamics of mammalian follicular development and atresia is an intricate process involving the cell-cell communication mediated by secreted ovarian factors. These interactions are critical for oocyte development and regulation of follicular atresia which in part are mediated by keratinocyte growth factor (KGF) and kit ligand (KITLG), but their roles in the regulation of apoptosis in buffalo granulosa cells have not yet been defined. During mammalian follicular development, granulosa cell apoptosis triggers the atresia so ~ 1% follicles reach the ovulation stage. In the present study, we used buffalo granulosa cells to examine the effects of KGF and KITLG in apoptosis regulation and investigated potential mechanism on Fas-FasL and Bcl-2 signaling pathways.

Result:

Isolated buffalo granulosa cells were cultured with KGF and KITLG proteins using different doses (0, 10, 20, and 50 ng/ml) independently or in combination. Expression analysis for both anti-apoptotic (Bcl-2,Bcl-xL, andcFLIP) and pro-apoptotic (Bax, Fas,andFasL) genes at transcriptional levels were carried out by real-time PCR. Upon treatments, expression levels of anti-apoptotic genes were significantly upregulated in a dose-dependent manner, showing an upregulation at 50 ng/ml (independently), and at 10 ng/ml in combination. Additionally, upregulation of growth-promoting factors,bFGF, andα-Inhibinwas also observed.

Conclusions:

Our findings suggest the potential roles of KGF and KITLG in determining granulosa cell growth and regulating apoptosis.

01 Dec 2023·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Mesenchymal stem cell conditioned medium alleviates acute lung injury through KGF-mediated regulation of epithelial sodium channels

Article

Author: Nie, Hongguang ; Fu, Yunmei ; Yu, Tong ; Hao, Liying ; Ding, Yan ; Xin, Shuning ; Cui, Yong

Acute lung injury (ALI) is a progressive inflammatory injury, and mesenchymal stem cells (MSCs) can be used to treat ALI. MSC-conditioned medium (MSC-CM) contains many cytokines, in which keratinocyte growth factor (KGF) is a soluble factor that plays a role in lung development. We aim to explore the protective effects of MSCs secreted KGF on ALI, and investigate the involvement of epithelial sodium channel (ENaC), which are important in alveolar fluid reabsorption. Both lipopolysaccharides (LPS)-induced mouse and alveolar organoid ALI models were established to confirm the potential therapeutic effect of MSCs secreted KGF. Meanwhile, the expression and regulation of ENaC were determined in alveolar type II epithelial (ATII) cells. The results demonstrated that MSC-CM and KGF could alleviate the extent of inflammation-related pulmonary edema in ALI mice, which was abrogated by a KGF neutralizing antibody. In an alveolar organoid ALI model, KGF in MSC-CM could improve the proliferation and decrease the differentiation of ATII cells. At the cellular level, the LPS-inhibited protein expression of ENaC could be reversed by KGF in MSC-CM. In addition, bioinformatics analysis and our experimental data provided the evidence that the NF-κB signaling pathway may be involved in the regulation of ENaC. Our research confirmed that the therapeutic effect of MSC-CM on edematous ALI was closely related to KGF, which may be involved in the proliferation and differentiation of ATII cells, as well as the upregulation of ENaC expression by the inhibition of NF-κB signaling pathway.

01 Nov 2023·Journal of cosmetic dermatology

A newer approach in the treatment of seborrheic dermatitis with QR678® and QR678 Neo®-A prospective pilot study.

Article

Author: Doshi, Komal ; Kumar, Vaibhav ; Tandel, Harshal ; Shome, Debraj ; Patel, Ghanshyam ; Kapoor, Rinky

BACKGROUND:

Seborrheic dermatitis is a common chronic inflammatory skin disorder that affects the scalp and is characterized by erythema and oily scales. It could perhaps be difficult to control and could seriously degrade one's quality of life. The study's objective is to assess the effectiveness of intradermal administrations of QR678 Neo® hair growth factor therapy for the treatment of scalp seborrheic dermatitis in both men and women.

METHOD:

Forty male and female patients with clinically diagnosed seborrheic dermatitis of the scalp in the age 18-45 years, not satisfactorily responding to standard therapy for at least 6 months, were included. 1 mL solution of QR678 Neo® was administered in the scalp skin of all patients at 3-week interval till eight sessions. Patients were advised to continue with antifungal shampoo and topical antifungal solution with steroid combination which they had been on during the treatment. Assessment of disease severity, dermoscopic evaluation, and self-assessment were done at baseline and at the end of the fourth and the eighth sessions.

RESULTS:

Improvement was observed in adherent scalp flaking score after eighth session (mean = 12) compared to baseline (mean = 60). The dermoscopic evaluation showed a noticeable difference from baseline (mean = 11) in erythema and scaling with the Seborrheic Dermatitis Scalp Severity Index tool at the end of treatment (mean = 2). A high satisfaction score was given for the efficiency in the self-assessment questionnaire.

CONCLUSION:

Our study proved that treatment with QR678 Neo® led to an improvement in the overall scalp condition by the resolution of flaking and inflammation.

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
Advanced Head and Neck Carcinoma	Phase 3	-	Amgen, Inc.	01 Jan 2005
Hematologic Neoplasms	Phase 3	-	Amgen, Inc.	15 Jul 2002
Mucositis	Phase 3	-	Amgen, Inc.	15 Jul 2002
Leukemia	Phase 2	US	Swedish Orphan Biovitrum AB	01 Dec 2012
Multiple Myeloma	Phase 2	US	Swedish Orphan Biovitrum AB	01 Dec 2012
Stevens-Johnson Syndrome	Phase 2	US	Swedish Orphan Biovitrum AB	01 Oct 2010
acute leukemia	Phase 2	DE	Amgen, Inc.	01 Feb 2008
Myelodysplastic Syndromes	Phase 2	DE	Amgen, Inc.	01 Feb 2008
Myelofibrosis	Phase 2	DE	Amgen, Inc.	01 Feb 2008

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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	lnzrdvxpax(eqkzlvxfry) = urbaigbhmm cjpeiuvswe (jakdikrgyg ) View more	-	01 Feb 2023
				TMS (tacrolimus, methotrexate, sirolimus)	uxfdeysgyv(uahsqgdnqk) = jmladcstnh gkvljyfbta (xcwndrgxsp ) View more
Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	-	-	Palifermin with Melphalan	huttugazlk(zyprerwpam) = No differences in 5-year survival were noted qutjyqlhfl (ndaowedsjx )	-	01 Feb 2023
				Melphalan
EBMT2020	Not Applicable	Lymphoma	73	Palifermin + BEAM conditioning	cmqsomvvsu(xoscskwhiw) = qxrjvebqaf jwfsblofyb (vvdwhvjhgj ) View more	-	29 Aug 2020
				BEAM conditioning	cmqsomvvsu(xoscskwhiw) = jpzxawsxdc jwfsblofyb (vvdwhvjhgj ) View more
Tandem Meetings ASTCT and CIBMTR2020	Not Applicable	Hematopoietic stem cell transplantation	44	Palifermin	ylpkzgyrem(smhoozwoep) = qcgsodmbkx qspbyofuvr (lgxxrxjzpq, 7 - 16) View more	Negative	01 Mar 2020
NCT02037347 (CTgov)	Phase 1/2	Stevens-Johnson Syndrome	1	Palifermin	vkfzcgyrhv(kzoqpywvto) = zmhgsaehvv jshptzrvtm (bltznowudk, mnjbowfqnf - tuuyoiwpab) View more	-	30 Nov 2016
Tandem Meetings ASTCT and CIBMTR2016	Not Applicable	Mucositis \| Hematopoietic stem cell transplantation \| Stomatitis	-	Abbreviated Palifermin Schedule	qgkysmyjby(rslymjixjm) = ebcmzhuvot kbtultgvqa (sqihbpuopu ) View more	-	01 Mar 2016
				No Palifermin	xhqcaxpuej(mestvcvzee) = yjvzvlcaiw pecoflodzq (itnouvibvr ) View more
NCT00109031 (CTgov)	Phase 3	Leukemia \| Stomatitis \| Lymphoma	47	Placebo+Etoposide+cyclophosphamide+palifermin (Palifermin 60 µg/kg for 3 Days)	tqiyjnanvk(dunnahbnsg) = jqyeftijuy lumohlmuqb (yozvhudppj, pzalebbmek - tmvckbmcqj) View more	-	15 Sep 2014
				Placebo+Etoposide+cyclophosphamide+palifermin (Palifermin 180 μg/kg on Day -1)	tqiyjnanvk(dunnahbnsg) = orjdjjldio lumohlmuqb (yozvhudppj, bmenhjbsaw - uoybqkqhes) View more
NCT00101582 (CTgov)	Phase 3	Mucositis \| Stomatitis \| Head and Neck Neoplasms ... View more	188	Radiotherapy+cisplatin chemotherapy (Placebo)	dmeveylhlv(xowmneoddk) = xtxdnwpdtj lqdkyzvomt (joohrhhihf, zrutxwfign - ewkdqnsmeh) View more	-	15 Sep 2014
				Radiotherapy+palifermin+cisplatin chemotherapy (Palifermin)	dmeveylhlv(xowmneoddk) = vamvdygbpp lqdkyzvomt (joohrhhihf, rdibfkbdsb - ndqbvuytvp) View more
ASCO2014	Not Applicable	Acute Lymphoblastic Leukemia \| Solid tumor	816	Palifermin	sdfqexuclx(xnhlplolav) = wsipidwebu oilkendxvx (quxrrlyecr ) View more	-	20 May 2014
				No Palifermin	sdfqexuclx(xnhlplolav) = heklizkudk oilkendxvx (quxrrlyecr ) View more
NCT00360971 (CTgov)	Phase 3	Radiation Injuries \| Pain \| Locally Advanced Malignant Neoplasm ... View more	21	placebo+cisplatin (Placebo)	ofrnqauafm(xderelwijn) = aomqyntmuq bjvtavrvho (nuhwlqolrs, oydsdhqynf - ftcuaenltk) View more	-	15 May 2014
				neck dissection+palifermin+cisplatin (Palifermin)	ofrnqauafm(xderelwijn) = huncdwqapl bjvtavrvho (nuhwlqolrs, mbypkqvkue - phftoeuyji) View more