Delving into the Latest Updates on Palifermin with Synapse

This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and/or effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.

Start Date05 Apr 2027

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07775313

/ Not yet recruitingPhase 1/2IIT

Phase 1/2 Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM

Background:
Warts, hypogammaglobulinemia, infections and myelokathexis syndrome (WHIMs) is a rare disorder that affects the immune system. People with WHIMs can have severe infections all over their body. WHIMs is caused by a mutation in the CXCR4 gene. Treatment with drugs can help control the infections but does not cure the disorder. Researchers want to try a treatment where they collect stem cells from a person with WHIMS, use base-editing to replace the bad gene with a healthy version, and return the new cells to the person. This could cure WHIMs.
Objective:
To test a treatment using base-edited stem cells in people with WHIMs.
Eligibility:
People aged 3 years and older with WHIMs.
Design:
The study has 4 stages.
Stage 1: Screening. Participants will be screened at 1 or more visits. They will have a physical exam with blood tests. A sample of tissue and fluid (biopsy) will be taken from the bone marrow in the hip.
Stage 2: Apheresis. Blood will be taken from the body through a needle; the blood will pass through a machine that separates out the stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will undergo gene editing.
Stage 3: Treatment. Participants will stay in the hospital for about 4 weeks. They will receive 3 drugs to prepare their body for the procedure. Then the edited stem cells will be returned to their bloodstream. They will stay in the hospital until they recover.
Stage 4: Follow-up. Participants will have 8 follow-up visits over 5 years. Long-term visits will continue for 15 years.

Start Date16 Sep 2026

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT06959771

/ RecruitingPhase 1/2IIT

Base Editing Hematopoietic Stem Cell and BE T Cell Gene Therapy for CD40L-HyperIgM Syndrome-Single Patient Study

Background:
X-linked hyper-IgM (HIGM) syndrome is caused by a mutation in the CD40 ligand (CD40L) gene. People with this disease have white blood cells that do not work properly. These people are at risk of severe infections and autoimmune diseases. Researchers want to know if these base-edited stem cells and T cells can help people with CD40L-HIGM syndrome.
Objective:
To test base-edited stem cells and base-edited T cells in 1 person with CD40L-HIGM syndrome.
Eligibility:
A single male with CD40L-HIGM syndrome.
Design:
A single participant is planned to receive a single dose of edited stem cells and supportive treatment with edited T cells. Participant stem and T cells will undergo base editing to repair the mutation.
In preparation for the gene therapy, the participant will receive busulfan chemotherapy and alemtuzumab. After treatment, the participant will have follow-up visits every few months in the first 2 years after treatment. Long-term visits will continue annually for 15 years.

Start Date16 Jul 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

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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662

Literatures (Medical) associated with Palifermin

01 Jun 2026·INTERNATIONAL JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY

Clinical evidence for managing radiotherapy-induced oral mucositis and xerostomia in head and neck cancer patients: a review of Phase III–IV trials

Review

Author: Alsahafi, E

Oral Mucositis and xerostomia are common debilitating side effects of radiotherapy in head and neck cancer patients, leading to treatment interruptions and negatively impacting quality of life. This review was performed to examine the efficacy and safety of interventions for managing these complications, evaluated in completed Phase III and IV clinical trials registered on ClinicalTrials.gov. A range of pharmacological and non-pharmacological therapies were reviewed, with analysis of intervention types, outcomes, and sample sizes. For oral mucositis, effective pharmacological agents included palifermin, avasopasem manganese, doxepin, morphine mouthwash, and gabapentin, while non-pharmacological options such as low-level laser therapy, honey, and Aloe vera showed additional benefit in reducing severity and improving healing. In managing radiotherapy-induced xerostomia, pilocarpine, amifostine, and cevimeline significantly enhanced salivary function, with adaptive radiotherapy techniques offering protective effects on the salivary glands. Phase IV studies supported the role of benzydamine, MuGard, Biotène, and herbal mouthwashes in symptom relief and patient comfort. Although several interventions demonstrated promising clinical efficacy, the heterogeneity in study design, outcome measures, and follow-up duration limits definitive conclusions. Therefore, customized, evidence-driven approaches informed by existing recommendations and developed data are crucial for enhancing outcomes and reducing the burden of therapy-induced toxicities in head and neck cancer patients.

01 Apr 2026·Food Chemistry-X

Fermentation method outweighs geographic origin in shaping kefir's in vitro anti-obesity potential and probiotic properties

Article

Author: Li, Qiming ; Qu, Hengxian ; Gu, Ruixia ; Ji, Qingyang

Kefir is a traditional fermented dairy product containing diverse microbial consortia with potential health benefits. However, systematic comparisons of fermentation methods and grain origins on kefir's functional properties remain limited. This study selected kefir grains from eight geographic regions worldwide and prepared kefir fermented milk using both kefir grain fermentation (KGF) and back-slopping fermentation (BSF) methods. The in vitro anti-obesity potential and probiotic characteristics were evaluated, and multidimensional analysis was employed to elucidate the influence of different fermentation methods and regional sources on functional properties. Results demonstrated that the fermentation method exerted a stronger influence than geographic origin. KGF generally yielded kefir with higher antioxidant capacity, stronger antimicrobial activity, and safer probiotic profiles, whereas BSF favored lactic acid bacteria proliferation and triglyceride reduction. These findings emphasize that changes in fermentation strategy reshape the microbial community structure, thereby influencing the functional quality and probiotic properties of kefir. Consequently, KGF is recommended as the optimal strategy for producing kefir with enhanced health-promoting properties and superior safety.

01 Mar 2026·SUPPORTIVE CARE IN CANCER

Oral mucositis management in hematopoietic cell transplantation in Australia and New Zealand (CAN EAT Survey)

Article

Author: Gavin, Nicole C ; Munro, Emma ; Nakagaki, Midori

Abstract:

Purpose:

The Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) has published evidence-based international guidelines for the management of oral mucositis (OM). However, adherence to these guidelines has not been evaluated. This survey assessed OM management in hematopoietic cell transplantation (HCT) centers in Australia and New Zealand.

Methods:

Specialist nurses in 41 transplant hospitals were invited to complete a survey. Questions covered general unit information, oral assessment (tools, assessors, frequency), prevention strategies (guidelines, oral care, cryotherapy, photobiomodulation, palifermin, and barriers to use), and treatment strategies (pain management and nutritional support).

Results:

Of 41 hospitals, 24 (59%) responded. All but one responder were specialized nurses. Oral assessment was primarily conducted by nurses (100%) and doctors (80%). The most commonly used tools were the World Health Organization grading scale (42%), pain scores (46%), and EviQ (Australian online cancer resource) (42%). EviQ guidelines (67%), which exclude palifermin and photobiomodulation, followed by institutional guidelines (29%) and MASCC/ISOO guidelines (17%). Oral care (100%) and cryotherapy with melphalan (96%) were widely adopted, while photobiomodulation and palifermin were rarely used due to cost and access barriers. For OM-related pain, as-needed opioids (100%), patient-controlled analgesia (58%), and topical analgesics (46%) were common. When OM impaired oral intake, supportive measures included supplemental drinks (88%), enteral nutrition (50%), and parenteral nutrition (67%).

Conclusion:

In Australia and New Zealand, national EviQ guidelines are used more often than the MASCC/ISOO guidelines. Feasibility for implementing palifermin and photobiomodulation should be reassessed, and greater collaboration in developing guidelines is necessary.

1

News (Medical) associated with Palifermin

01 Apr 2025

·www.prnewswire.com

PeptiGrowth Inc. is Launching a Novel Synthetic Peptide: KGF alternative peptide (FGFR2b agonist)

TOKYO, April 1, 2025 /PRNewswire/ -- PeptiGrowth Inc. (Headquarters: Chiyoda-ku, Tokyo, President: Junichiro Ishizuka) has successfully developed a novel synthetic peptide called "KGF alternative- peptide (FGFR2b agonist)" which is functionally equivalent to recombinant keratinocyte growth factor (KGF). This product will be on the market beginning April 2025. Continue Reading Mechanism of Action of PG-012, a KGF Alternative Peptide "ERK phosphorylation and cell proliferation activity of PG-012 and KGF in FGFR2b-overexpressing BaF cells. Development of Synthetic Peptide Growth Factors by PeptiGrowth Conventional growth factors and cytokines used in the manufacturing of regenerative medicine and cell therapy products face various quality challenges such as lot-to-lot variation, potential contamination with biological impurities, low stability, and high cost. PeptiGrowth has been working on the development of a series of synthetic peptides that can address these challenges while maintaining equivalent function to the conventional growth factors and cytokines on the market. Our peptides are completely chemically synthesized and animal component-free, enabling xeno-free and chemically defined cell culture media. About KGF alternative peptide (FGFR2b agonist) [Product code: PG-012] Mechanism of activating FGFR2b by the KGF alternative peptide (PG-012) PG-012, KGF alternative peptide, is a dimeric peptide composed of cyclic peptides designed to bind specifically to FGFR2b. Like KGF, PG-012 effectively interacts with FGFR2b and exhibits agonistic activity against FGFR2b (see diagram below). Comparable signal activation activity to recombinant KGF We conducted a comparative study on the functions of KGF alternative peptide (PG-012) and commercially available recombinant KGF using FGFR2b-overexpressing BaF3 cells. We confirmed that the KGF alternative peptide activates ERK (upper left figure) and exhibits proliferation activity (upper right figure) in a manner similar to recombinant KGF at lower concentrations (ng/mL basis). We anticipate that the KGF alternative peptide (PG-012) will be applicable in regenerative medicine and cell therapy, particularly in applications such as differentiation and proliferation of epidermal cells and cells derived from the endoderm, such as alveolar epithelial cells, islet cells, and hepatocytes, from pluripotent stem cells. Product Overview Product name: KGF alternative peptide (FGFR2b agonist) Product code: PG-012 Product form: Lyophilized Storage conditions: -20°C or less Purity: ≥95% by HPLC Molecular weight: 6018.40 (Acetate) Size: 10 μg, 100 μg, 1 mg (volume per vial) *This product can be provided with an Animal Component Free (ACF) certificate. *This product is for testing and research use only (RUO). *There is a possibility that the specifications can change. Purchase Our Product If you would like to purchase our products, please contact us using the information below. For customers who would like to purchase GMP compliant products as well as the above PG products in bulk scale, please contact us using the information below. Contact InformationPeptiGrowth Inc. Tel: + 81-(0)70-7789-3905 E-mail: [email protected] Development of other peptides from PeptiGrowth We have developed alternative peptides targeting numerous growth factors and cytokines. To date, we have launched 12 products and plan to launch additional growth-factor alternative peptides targeting PDGF-AA and IL-15 by the end of 2025. SOURCE PeptiGrowth Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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KEGG	Wiki	ATC	Drug Bank
D05338	Palifermin	V03AF08	DB00039

R&D Status

Approved

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

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Cancer	Phase 3	-	Amgen, Inc.	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
Head and Neck Neoplasms	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
Multiple Myeloma	Phase 3	-	Amgen, Inc.	15 Jul 2002
Non-Hodgkin Lymphoma	Phase 3	-	Amgen, Inc.	15 Jul 2002

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02356159 (CTgov)	Phase 1/2	Hodgkin's Lymphoma \| Multiple Myeloma \| acute leukemia ... View more	34	Epinephrine+PET+Acetaminophen+Prednisone+Palifermin+Diphenhydramine+Rituximab (2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose)	abuygzkvzn = cfypgkburo mkvamiohdl (pbkegvrbid, aqohcdxhst - hugswrwdqk)	-	05 Jun 2025
				Epinephrine+PET+Acetaminophen+Prednisone+Palifermin+Diphenhydramine+Rituximab (1/Phase 1: Dose Escalation Arm - Palifermin)	arrrozzagc = czjdqawvli zvbkhxidbn (bjjxmrrscn, htwkkizezb - hwccxtnfuv)
Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	Graft vs Host Disease	-	Palifermin 540 µg/kg	aawntmjuts(vqulyaoigb) = hjixcjngce ptlfdsrhmv (alscuuvzyz ) View more	-	01 Feb 2023
				TMS (tacrolimus, methotrexate, sirolimus)	eybrkwyarr(tjkqkldtjm) = ukblskcywu xvgasntfyu (xpffvawhmk ) View more
EBMT2020	Not Applicable	Lymphoma	73	Palifermin + BEAM conditioning	gqwofdadme(suzzkvxdio) = tnbntswyzl kqllqiidhp (ensxtmpafx ) View more	-	29 Aug 2020
				BEAM conditioning	gqwofdadme(suzzkvxdio) = qhsfuweczx kqllqiidhp (ensxtmpafx ) View more
Tandem Meetings ASTCT and CIBMTR2020	Not Applicable	Hematopoietic stem cell transplantation	44	Palifermin	kpdbwwaokd(ctxgrluqee) = necmxhkmgg egadyztzxw (cuhdxxkusi, 7 - 16) View more	Negative	01 Mar 2020
NCT00593554 (CTgov)	Phase 2	Acute Myeloid Leukemia \| Anemia, Refractory, With Excess of Blasts \| Chronic phase chronic myeloid leukemia ... View more	9	Paliferim (Treatment Without Paliferim)	mskcfxidwu = fmdtittmiy qfextrpirc (ikknlldbdc, llceyqwenm - ccmyscwcwg) View more	-	10 Apr 2018
				Palifermin (Treatment With Palifermin)	mskcfxidwu = icadjbnwrd qfextrpirc (ikknlldbdc, mtdwovxjsm - uraclvftzc) View more
NCT01746173 (CTgov)	Phase 2	T-Cell Lymphoma	5	Stem Cell Transplant+Etoposide+Busulfan+Cyclophosphamide+prednisone+Filgrastim+Melphalan+Doxorubicin+Gemcitabine+Palifermin+Plerixafor+Vincristine	cgygsfsfch = wbpdvcmljo wbdeksvvqr (nhgevgjktf, eipuzvkyvk - wuzkorwntu) View more	-	11 Jan 2017
NCT02037347 (CTgov)	Phase 1/2	Stevens-Johnson Syndrome	1	Palifermin	wzevwxbakc = zgyhejuphv uwutajwivf (hunlgtjldb, pwifubvrsy - wqqymnkyua) View more	-	30 Nov 2016
Tandem Meetings ASTCT and CIBMTR2016	Not Applicable	Mucositis \| Hematopoietic stem cell transplantation \| Stomatitis	-	Abbreviated Palifermin Schedule	icyjvjsxfb(rsjiaqzpsx) = twbfmboqgt adingkqnda (vvrwsdoiwi ) View more	-	01 Mar 2016
				No Palifermin	ldmzlffhor(ogovnsatnm) = sffmhvhgxd klgrfqtuwo (ugdyjkgpng ) View more
NCT00101582 (CTgov)	Phase 3	Mucositis \| Stomatitis \| Head and Neck Neoplasms ... View more	188	Radiotherapy+cisplatin chemotherapy (Placebo)	jsoanqgnte = ubscnkgsrx cpczhpbnus (xzzvmuwfkr, stpmndcklt - rsddwzljzv) View more	-	15 Sep 2014
				Radiotherapy+palifermin+cisplatin chemotherapy (Palifermin)	jsoanqgnte = lwwahhtevh cpczhpbnus (xzzvmuwfkr, yqngwiisdd - hisodyntza) View more
NCT00109031 (CTgov)	Phase 3	Acute Myeloid Leukemia \| Hodgkin's Lymphoma \| Chronic Lymphocytic Leukemia ... View more	47	Placebo+Etoposide+Cyclophosphamide+palifermin (Palifermin 60 µg/kg for 3 Days)	eutuzuflnc = rficsjjlzg jxonaqdjar (ovjlumsuta, xqohjsdnfd - ifmxzzruab) View more	-	15 Sep 2014
				Placebo+Etoposide+Cyclophosphamide+palifermin (Palifermin 180 μg/kg on Day -1)	eutuzuflnc = zlevjofvqy jxonaqdjar (ovjlumsuta, dekpqhbfkr - ovbbouhnui) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Palifermin

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