Identification

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Name
Regramostim
Accession Number
DB05386
Type
Biotech
Groups
Investigational
Biologic Classification
Protein Based Therapies
Other protein based therapies
Description

Regramostim (GM-CSF) is a differentially glycosylated factor produced mainly by activated T cells and macrophages. Endothelial cells and fibroblasts can also produce GM-CSF after exposure to TNF-α, IL-1, IL-2 and IFN-γ. GM-CSF is found associated with extracellular matrix and in membrane-bound formats too. GM-CSF stimulates proliferation, activation and differentiation of macrophages and granulocytes and their progenitors.

Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
Not Available
Synonyms
  • Colony-stimulating factor 2 (human clone pCSF-1 protein moiety reduced), glycoform GMC 89-107
  • GM-CSF
  • Regramostim
  • Regramostime
  • Regramostimum
  • rhGm-CSF
External IDs
GMC 89-107
Categories
UNII
KR89Q40F01
CAS number
127757-91-9

Pharmacology

Indication

Investigated for use/treatment in adverse effects (chemotherapy) and bone marrow transplant.

Pharmacodynamics
Not Available
Mechanism of action

This drug activates mononuclear phagocytes, promotes migration of epithelial cells, and further regulates cytokine production. In 2 recent placebo-controlled studies involving venous leg ulceration, subcutaneous perilesional injections of recombinant human granulocyte-macrophage colony-stimulating factor were found to be significantly better than placebo in the time to complete wound healing. In other studies, recombinant human granulocyte-macrophage colony-stimulating factor was administered topically to wounds. Several case reports have also demonstrated the use of recombinant human granulocyte-macrophage colony-stimulating factor for postsurgical wounds, chronic leg ulcers of sickle cell anemia patients, and refract and refractory pyoderma gangrenosum.

TargetActionsOrganism
UGranulocyte-macrophage colony-stimulating factor receptor subunit alphaNot AvailableHumans
UGM-CSF receptor alpha subunitNot AvailableHumans
Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life
Not Available
Clearance
Not Available
Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AcebutololRegramostim may increase the bradycardic activities of Acebutolol.
AcetylcholineThe risk or severity of adverse effects can be increased when Regramostim is combined with Acetylcholine.
AclidiniumThe therapeutic efficacy of Aclidinium can be decreased when used in combination with Regramostim.
AgmatineThe therapeutic efficacy of Agmatine can be decreased when used in combination with Regramostim.
AlcuroniumRegramostim may decrease the neuromuscular blocking activities of Alcuronium.
AldosteroneThe therapeutic efficacy of Regramostim can be decreased when used in combination with Aldosterone.
AlprenololRegramostim may increase the bradycardic activities of Alprenolol.
AmantadineThe therapeutic efficacy of Amantadine can be decreased when used in combination with Regramostim.
AmifampridineThe risk or severity of adverse effects can be increased when Regramostim is combined with Amifampridine.
AmitriptylineThe therapeutic efficacy of Amitriptyline can be decreased when used in combination with Regramostim.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

    Learn more
  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

References

General References
  1. Sardana R, Dudani AK, Tackaberry E, Alli Z, Porter S, Rowlandson K, Ganz P, Altosaar I: Biologically active human GM-CSF produced in the seeds of transgenic rice plants. Transgenic Res. 2007 Dec;16(6):713-21. Epub 2007 Feb 16. [PubMed:17985214]
  2. Rosas M, Gordon S, Taylor PR: Characterisation of the expression and function of the GM-CSF receptor alpha-chain in mice. Eur J Immunol. 2007 Sep;37(9):2518-28. [PubMed:17694571]
External Links
PubChem Substance
347910111

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0CompletedTreatmentMelanoma1
0RecruitingTreatmentNeuroblastoma (NB)1
0TerminatedTreatmentMyelodysplastic Syndromes1
1Active Not RecruitingTreatmentFollicular Lymphoma (FL)1
1Active Not RecruitingTreatmentGlioblastomas / Malignant Gliomas / Pediatric Brain Tumor / Pediatric Brain Tumor, Recurrent / Pediatric Glioblastoma Multiforme / Recurrent Medulloblastoma1
1Active Not RecruitingTreatmentProstate Cancer2
1CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections2
1CompletedTreatmentAcute Respiratory Distress Syndrome (ARDS) / Bronchiectasis / Cystic Fibrosis (CF) / Pulmonary Alveolar Proteinosis (PAP)1
1CompletedTreatmentCancer, Breast1
1CompletedTreatmentCarcinoma, Colorectal1
1CompletedTreatmentEwing's Sarcoma (ES) / Malignant Lymphomas / Neuroblastomas / Rhabdomyosarcomas / Wilms' tumor1
1CompletedTreatmentFollicular Lymphoma (FL) / Lymphoma, B Cell / Malignant Lymphomas1
1CompletedTreatmentHodgkins Disease (HD) / Leukemias / Multiple Myeloma (MM) / Non-Hodgkin's Lymphoma (NHL) / Other Plasma Cell Dyscrasia (Waldenstrom, Amyloidosis)1
1CompletedTreatmentInfection, Mycobacterium Avium-Intracellulare1
1CompletedTreatmentLung Cancers / Melanoma / Renal Cell Adenocarcinoma / Squamous Cell Carcinoma of the Head and Neck (SCCHN)1
1CompletedTreatmentMalignant Melanoma1
1CompletedTreatmentMalignant Neoplasm of Pancreas1
1CompletedTreatmentMalignant Neoplasm of Pancreas / Resectable Pancreatic Adenocarcinoma1
1CompletedTreatmentMelanoma (Skin)1
1CompletedTreatmentMultiple Myeloma (MM)1
1CompletedTreatmentProstate Cancer1
1Not Yet RecruitingTreatmentAnatomic Stage III Breast Cancer AJCC v8 / Anatomic Stage IIIA Breast Cancer AJCC v8 / Anatomic Stage IIIB Breast Cancer AJCC v8 / Anatomic Stage IIIC Breast Cancer AJCC v8 / Anatomic Stage IV Breast Cancer AJCC v8 / Estrogen Receptor Positive / HER2/Neu Negative / Invasive Breast Carcinoma / Prognostic Stage III Breast Cancer AJCC v8 / Prognostic Stage IIIA Breast Cancer AJCC v8 / Prognostic Stage IIIB Breast Cancer AJCC v8 / Prognostic Stage IIIC Breast Cancer AJCC v8 / Prognostic Stage IV Breast Cancer AJCC v8 / Recurrent Breast Carcinoma1
1Not Yet RecruitingTreatmentMelanoma (Skin)1
1Not Yet RecruitingTreatmentMetastatic Breast Cancer (MBC)1
1RecruitingTreatmentAdvanced Tumor / Metastatic Tumors1
1RecruitingTreatmentDiffuse Intrinsic Pontine Glioma (DIPG)1
1RecruitingTreatmentDuctal Breast Carcinoma In Situ / HER2/Neu Positive1
1RecruitingTreatmentGlioblastomas / Glioma of Brainstem / Glioma, Malignant / High Grade Glioma (HGG) / Overall Survivals / Recurrent Glioblastoma1
1RecruitingTreatmentMalignant Gliomas1
1RecruitingTreatmentMalignant Melanoma1
1RecruitingTreatmentPosterior Fossa Ependymoma (PFEPN)1
1RecruitingTreatmentRectal Adenocarcinoma / Stage III Rectal Cancer AJCC v7 / Stage IIIA Rectal Cancer AJCC v7 / Stage IIIB Rectal Cancer AJCC v7 / Stage IIIC Rectal Cancer AJCC v7 / Stage IV Rectal Cancer AJCC v7 / Stage IVA Rectal Cancer AJCC v7 / Stage IVB Rectal Cancer AJCC v71
1SuspendedTreatmentRheumatoid Arthritis1
1TerminatedTreatmentCancer of Liver / Cancer of the Liver / Hepatic neoplasms malignant / Hepatocellular Cancer / Hepatocellular,Carcinoma / Liver Cancer / Liver Cancer, Adult / Liver Cell Carcinoma / Liver Cell Carcinoma, Adult / Neoplasms, Hepatic1
1TerminatedTreatmentMetastatic Cancers / Neoplasms / Tumors / Tumors, Solid1
1WithdrawnTreatmentStage 0 Bladder Urothelial Carcinoma AJCC v6 and v7 / Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7 / Stage 0is Bladder Urothelial Carcinoma AJCC v6 and v7 / Stage I Bladder Urothelial Carcinoma AJCC v6 and v71
1, 2Active Not RecruitingTreatmentAdvanced Renal Cell Cancer / Renal Cell Adenocarcinoma1
1, 2Active Not RecruitingTreatmentColorectal Cancers1
1, 2Active Not RecruitingTreatmentMelanoma1
1, 2Active Not RecruitingTreatmentRecurrent Prostate Cancer1
1, 2Active Not RecruitingTreatmentRenal Cancers1
1, 2CompletedPreventionCancer, Breast2
1, 2CompletedTreatmentMalignancies, Hematologic1
1, 2CompletedTreatmentMalignant Melanoma2
1, 2CompletedTreatmentMultiple Myeloma (MM)1
1, 2CompletedTreatmentNeuroblastomas1
1, 2CompletedTreatmentProstate Cancer4
1, 2CompletedTreatmentProstatic Neoplasms1
1, 2RecruitingPreventionDCIS1
1, 2RecruitingTreatmentMetastatic Melanoma1
1, 2RecruitingTreatmentNeuroblastomas1
1, 2RecruitingTreatmentPrimary/Relapsed Acute Lymphoblastic Leukemia (ALL) of Childhood, Adolescents and Young Adults1
1, 2Unknown StatusTreatmentHepatitis B Chronic Infection1
1, 2Unknown StatusTreatmentProstate Cancer1
1, 2WithdrawnTreatmentMalignant Lymphomas1
2Active Not RecruitingTreatmentCancer of the Ovary / Fallopian Tube Cancer / Primary Peritoneal Cancer1
2Active Not RecruitingTreatmentCancer of the Ovary / Platinum Sensitive Ovarian Cancer1
2Active Not RecruitingTreatmentMalignant Neoplasm of Pancreas1
2Active Not RecruitingTreatmentMalignant Pleural Mesothelioma (MPM)1
2Active Not RecruitingTreatmentMantle Cell Lymphoma (MCL)1
2Active Not RecruitingTreatmentNeuroblastomas1
2Active Not RecruitingTreatmentProstate Cancer2
2CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections1
2CompletedTreatmentAcute Myelogenous Leukaemia (AML)1
2CompletedTreatmentAppendicitis1
2CompletedTreatmentAppendicitis perforated1
2CompletedTreatmentBurkitt's Lymphoma / Lymphoma, Large-Cell, Diffuse / Lymphoma, Small Noncleaved-Cell1
2CompletedTreatmentCancer, Breast / Inflammatory carcinoma of the breast / Locally Advanced Breast Cancer (LABC)1
2CompletedTreatmentCancer, Breast / Neoplasms, Breast1
2CompletedTreatmentEwing's Sarcoma (ES) / Rhabdomyosarcomas1
2CompletedTreatmentGiant Cell Glioblastoma / Glioblastoma With Oligodendroglial Component / Glioblastomas / Gliosarcoma / Recurrent Glioblastoma / Relapsed Glioblastoma / Small Cell Glioblastoma1
2CompletedTreatmentHCC / Hepatocellular,Carcinoma / Liver Cancer1
2CompletedTreatmentHepatic Metastases / Uveal Melanoma1
2CompletedTreatmentHepatitis B Chronic Infection1
2CompletedTreatmentHepatocellular Carinoma1
2CompletedTreatmentHormone-Resistant Prostate Cancer / Metastatic Hormone Refractory Prostate Cancer / Recurrent Prostate Carcinoma / Stage IV Prostate Cancer1
2CompletedTreatmentLymphoma, Large B-Cell, Diffuse (DLBCL)1
2CompletedTreatmentMalignant Melanoma2
2CompletedTreatmentMalignant Neoplasm of Colon / Metastatic Colon Cancer / Metastatic Rectal Cancer / Rectal Carcinoma1
2CompletedTreatmentMalignant Pleural Mesothelioma (MPM)1
2CompletedTreatmentMelanoma3
2CompletedTreatmentMelanoma (Skin)1
2CompletedTreatmentNeuroblastomas2
2CompletedTreatmentProstate Cancer3
2CompletedTreatmentRenal Cell Adenocarcinoma1
2CompletedTreatmentRespiratory Distress Syndrome, Adult1
2CompletedTreatmentSepsis1
2Not Yet RecruitingTreatmentMetastatic Colorectal Cancers1
2RecruitingTreatmentAcute Respiratory Distress Syndrome (ARDS)1
2RecruitingTreatmentAdvanced Melanoma / Recurrent Melanoma / Stage III Cutaneous Melanoma AJCC v7 / Stage IIIA Cutaneous Melanoma AJCC v7 / Stage IIIA Skin Melanoma / Stage IIIB Cutaneous Melanoma AJCC v7 / Stage IIIB Skin Melanoma / Stage IIIC Cutaneous Melanoma AJCC v7 / Stage IIIC Skin Melanoma / Stage IV Cutaneous Melanoma AJCC v6 and v7 / Stage IV Skin Melanoma / Stages III Skin Melanoma / Unresectable Melanoma1
2RecruitingTreatmentAstrocytoma, Grade IV / GBM / Glioblastoma Multiforme (GBM) / Glioblastomas / Malignant Gliomas1
2RecruitingTreatmentAutoimmune Pulmonary Alveolar Proteinosis1
2RecruitingTreatmentCancer, Breast / Malignant Chest Wall Neoplasm / Recurrent Breast Carcinoma / Recurrent Inflammatory Breast Carcinoma / Stage IV Breast Cancer AJCC v6 and v7 / Stage IV Inflammatory Breast Carcinoma1
2RecruitingTreatmentCystic Fibrosis (CF) / Mycobacterium Infections, Nontuberculous1
2RecruitingTreatmentDiffuse Sclerosis Systemic / Interstitial Lung Disease (ILD) / Pulmonary Hypertension (PH) / Sclerosis, Progressive Systemic1
2RecruitingTreatmentFNCLCC Sarcoma Grade 2 / FNCLCC Sarcoma Grade 3 / Leiomyosarcomas / Liposarcoma / Sarcoma Differentiation Score 2 / Sarcoma Differentiation Score 3 / Stage I Soft Tissue Sarcoma AJCC v7 / Stage IA Soft Tissue Sarcoma / Stage IA Soft Tissue Sarcoma AJCC v7 / Stage IB Soft Tissue Sarcoma / Stage IB Soft Tissue Sarcoma AJCC v7 / Stage II Soft Tissue Sarcoma AJCC v7 / Stage IIA Soft Tissue Sarcoma / Stage IIA Soft Tissue Sarcoma AJCC v7 / Stage IIB Soft Tissue Sarcoma / Stage IIB Soft Tissue Sarcoma AJCC v7 / Undifferentiated Pleomorphic Sarcoma1
2RecruitingTreatmentFollicular Lymphoma (FL)1
2RecruitingTreatmentLung Cancer Metastatic2
2RecruitingTreatmentMalignant Neoplasm of Colon1
2RecruitingTreatmentMultiple Myeloma (MM)2
2RecruitingTreatmentNSCLC Stage IV1
2RecruitingTreatmentNeuroblastomas2
2RecruitingTreatmentPulmonary Alveolar Proteinosis (PAP) / Treatments1
2RecruitingTreatmentRecurrent Osteosarcoma1
2SuspendedTreatmentAdnexal Carcinoma / Apocrine Carcinoma / Carcinoma, Adenoid Cystic / Eccrine Porocarcinoma / Extraocular Cutaneous Sebaceous Carcinoma / Hidradenocarcinoma / Keratoacanthoma / Malignant sweat gland neoplasm / Microcystic Adnexal Carcinoma / Neuroendocrine Carcinoma of the Skin / NK-Cell Lymphoma, Unclassifiable / Non-Melanomatous Lesion / Paget's Disease / Papillary Adenocarcinoma / Primary Cutaneous Mucinous Carcinoma / Refractory Anaplastic Large Cell Lymphoma / Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma / Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma / Refractory T-Cell Non-Hodgkin Lymphoma / Refractory, advanced Mycosis fungoides / Refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma / Sezary Syndrome / Signet Ring Cell Carcinoma / Skin Basal Cell Carcinoma / Skin Basosquamous Cell Carcinoma / Skin Squamous Cell Carcinoma / Spiradenocarcinoma / Squamous Cell Carcinoma of Unknown Primary / Squamous Cell Carcinoma of Unknown Primary Origin / Stage III Skin Cancer / Stage IV Skin Cancer / Sweat Gland Carcinoma / Trichilemmocarcinoma / Vulvar Squamous Cell Carcinoma1
2TerminatedTreatmentCarcinoma, Colorectal1
2TerminatedTreatmentHematologic Diseases1
2TerminatedTreatmentLymphoma, B-Cell / Lymphoma, Diffuse / Non-Hodgkin's Lymphoma (NHL)1
2TerminatedTreatmentRefractory, primary Neuroblastoma1
2Unknown StatusTreatmentLeukemia Acute Myeloid Leukemia (AML) / Myelodysplastic Syndrome1
2Unknown StatusTreatmentMalignant Neoplasm of Nasopharynx1
2Unknown StatusTreatmentPulmonary Alveolar Proteinosis (PAP)1
2WithdrawnTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)1
2, 3Active Not RecruitingTreatmentAutoimmune Pulmonary Alveolar Proteinosis1
2, 3TerminatedTreatmentBladder Cancers / Carcinoma in Situ / Carcinoma in Situ Concurrent With Papillary Tumors / Transitional Cell Carcinoma1
3CompletedTreatmentFevers / Hematologic Diseases / Neoplasms, Breast / Neutropenias / Sepsis1
3CompletedTreatmentGraft Versus Host Disease (GVHD) / Multiple Myeloma (MM)1
3CompletedTreatmentLeukemia Acute Myeloid Leukemia (AML)1
3CompletedTreatmentMelanoma2
3CompletedTreatmentMetastatic Hormone Refractory Prostate Cancer1
3CompletedTreatmentMultiple Myeloma (MM)1
3Enrolling by InvitationTreatmentAutoimmune Pulmonary Alveolar Proteinosis1
3Not Yet RecruitingTreatmentLeishmaniasis, Cutaneous1
3TerminatedTreatmentHead and Neck Carcinoma / Squamous Cell Carcinoma (SCC)1
3TerminatedTreatmentProstate Cancer1
3TerminatedTreatmentStage III Melanoma / Stage IV Melanoma1
3Unknown StatusTreatmentNon-Hodgkin's Lymphoma (NHL)1
4CompletedPreventionMycoses1
4CompletedTreatmentDeep Partial Thickness Burn1
4CompletedTreatmentHuman Immunodeficiency Virus (HIV)1
4CompletedTreatmentInfertilities2
4RecruitingTreatmentAcute Lymphocytic Leukemia (ALL) / Hepatoblastomas / Leukemia Acute Myeloid Leukemia (AML) / Malignant Lymphomas / Neuroblastomas / Retinoblastoma1
Not AvailableCompletedTreatmentEndotoxaemia / Inflammatory Reaction / Multi Organ Dysfunction Syndrome / Sepsis1
Not AvailableCompletedTreatmentLung Cancers1
Not AvailableCompletedTreatmentMelanoma1
Not AvailableCompletedTreatmentMyelodysplastic Syndrome RAEB-I or RAEB-II / Refractory Acute Myeloid Leukemia / Refractory CML Myeloid Blast Crisis1
Not AvailableCompletedTreatmentNeuroblastomas1
Not AvailableCompletedTreatmentPrimary Hepatocellular Carcinoma1
Not AvailableNot Yet RecruitingTreatmentThin Endometrium1
Not AvailableRecruitingTreatmentHepatitis B Chronic Infection1
Not AvailableRecruitingTreatmentLiver Cirrhosis1
Not AvailableUnknown StatusTreatmentColorectal Cancers1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
Not Available
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

Kind
Protein
Organism
Humans
Pharmacological action
Unknown
General Function
Receptor activity
Specific Function
Low affinity receptor for granulocyte-macrophage colony-stimulating factor. Transduces a signal that results in the proliferation, differentiation, and functional activation of hematopoietic cells.
Gene Name
CSF2RA
Uniprot ID
P15509
Uniprot Name
Granulocyte-macrophage colony-stimulating factor receptor subunit alpha
Molecular Weight
46206.185 Da
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
General Function
Not Available
Specific Function
Not Available
Gene Name
CSF2RA
Uniprot ID
Q16498
Uniprot Name
GM-CSF receptor alpha subunit
Molecular Weight
3014.39 Da

Enzymes

Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Inhibitor
General Function
Identical protein binding
Specific Function
Esterase with broad substrate specificity. Contributes to the inactivation of the neurotransmitter acetylcholine. Can degrade neurotoxic organophosphate esters.
Gene Name
BCHE
Uniprot ID
P06276
Uniprot Name
Cholinesterase
Molecular Weight
68417.575 Da
References
  1. Takahashi M, Nikkuni K, Moriyama Y, Shibata A: GM-CSF-mediated impairment of liver to synthesize albumin, cholinesterase, and cholesterol. Am J Hematol. 1991 Mar;36(3):213-4. [PubMed:1996559]

Drug created on November 18, 2007 11:24 / Updated on November 02, 2019 01:50