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Article: Small-Sized Co-Polymers for Targeted Delivery of Multiple Imaging and Therapeutic Agents.

Ljubimova, Julia Y / Ramesh, Arshia / Israel, Liron L / Holler, Eggehard

2021 Volume 11, Issue 11

Abstract: Research has increasingly focused on the delivery of high, often excessive amounts of drugs, neglecting negative aspects of the carrier's physical preconditions and biocompatibility. Among them, little attention has been paid to "small but beautiful" ... ...

Abstract	Research has increasingly focused on the delivery of high, often excessive amounts of drugs, neglecting negative aspects of the carrier's physical preconditions and biocompatibility. Among them, little attention has been paid to "small but beautiful" design of vehicle and multiple cargo to achieve effortless targeted delivery into deep tissue. The design of small biopolymers for deep tissue targeted delivery of multiple imaging agents and therapeutics (mini-nano carriers) emphasizes linear flexible polymer platforms with a hydrodynamic diameter of 4 nm to 10 nm, geometrically favoring dynamic juxtaposition of ligands to host receptors, and economic drug content. Platforms of biodegradable, non-toxic poly(β-l-malic acid) of this size carrying multiple chemically bound, optionally nature-derived or synthetic affinity peptides and drugs for a variety of purposes are described in this review with specific examples. The size, shape, and multiple attachments to membrane sites accelerate vascular escape and fast blood clearance, as well as the increase in medical treatment and contrasts for tissue imaging. High affinity antibodies routinely considered for targeting, such as the brain through the blood-brain barrier (BBB), are replaced by moderate affinity binding peptides (vectors), which penetrate at high influxes not achievable by antibodies.
Language	English
Publishing date	2021-11-08
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662255-5
ISSN	2079-4991
ISSN	2079-4991
DOI	10.3390/nano11112996
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Article ; Online: Magnetic iron oxide nanoparticles for imaging, targeting and treatment of primary and metastatic tumors of the brain.

Israel, Liron L / Galstyan, Anna / Holler, Eggehard / Ljubimova, Julia Y

Journal of controlled release : official journal of the Controlled Release Society

2020 Volume 320, Page(s) 45–62

Abstract: Magnetic nanoparticles in general, and iron oxide nanoparticles in particular, have been studied extensively during the past 20 years for numerous biomedical applications. The main applications of these nanoparticles are in magnetic resonance imaging ( ... ...

Abstract	Magnetic nanoparticles in general, and iron oxide nanoparticles in particular, have been studied extensively during the past 20 years for numerous biomedical applications. The main applications of these nanoparticles are in magnetic resonance imaging (MRI), magnetic targeting, gene and drug delivery, magnetic hyperthermia for tumor treatment, and manipulation of the immune system by macrophage polarization for cancer treatment. Recently, considerable attention has been paid to magnetic particle imaging (MPI) because of its better sensitivity compared to MRI. In recent years, MRI and MPI have been combined as a dual or multimodal imaging method to enhance the signal in the brain for the early detection and treatment of brain pathologies. Because magnetic and iron oxide nanoparticles are so diverse and can be used in multiple applications such as imaging or therapy, they have attractive features for brain delivery. However, the greatest limitations for the use of MRI/MPI for imaging and treatment are in brain delivery, with one of these limitations being the brain-blood barrier (BBB). This review addresses the current status, chemical compositions, advantages and disadvantages, toxicity and most importantly the future directions for the delivery of iron oxide based substances across the blood-brain barrier for targeting, imaging and therapy of primary and metastatic tumors of the brain.
MeSH term(s)	Blood-Brain Barrier ; Brain Neoplasms/diagnostic imaging ; Brain Neoplasms/therapy ; Ferric Compounds ; Humans ; Hyperthermia, Induced ; Magnetic Iron Oxide Nanoparticles ; Magnetic Resonance Imaging ; Magnetite Nanoparticles ; Nanoparticles
Chemical Substances	Ferric Compounds ; Magnetite Nanoparticles
Language	English
Publishing date	2020-01-07
Publishing country	Netherlands
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2020.01.009
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Article: Magnetic iron oxide nanoparticles for imaging, targeting and treatment of primary and metastatic tumors of the brain

Israel, Liron L / Galstyan, Anna / Holler, Eggehard / Ljubimova, Julia Y

Journal of controlled release. 2020 Apr. 10, v. 320

2020

Abstract	Magnetic nanoparticles in general, and iron oxide nanoparticles in particular, have been studied extensively during the past 20 years for numerous biomedical applications. The main applications of these nanoparticles are in magnetic resonance imaging (MRI), magnetic targeting, gene and drug delivery, magnetic hyperthermia for tumor treatment, and manipulation of the immune system by macrophage polarization for cancer treatment. Recently, considerable attention has been paid to magnetic particle imaging (MPI) because of its better sensitivity compared to MRI. In recent years, MRI and MPI have been combined as a dual or multimodal imaging method to enhance the signal in the brain for the early detection and treatment of brain pathologies. Because magnetic and iron oxide nanoparticles are so diverse and can be used in multiple applications such as imaging or therapy, they have attractive features for brain delivery. However, the greatest limitations for the use of MRI/MPI for imaging and treatment are in brain delivery, with one of these limitations being the brain-blood barrier (BBB). This review addresses the current status, chemical compositions, advantages and disadvantages, toxicity and most importantly the future directions for the delivery of iron oxide based substances across the blood-brain barrier for targeting, imaging and therapy of primary and metastatic tumors of the brain.
Keywords	blood-brain barrier ; brain ; chemical composition ; fever ; genes ; image analysis ; iron oxides ; macrophages ; magnetic resonance imaging ; metastasis ; nanoparticles ; neoplasms ; therapeutics ; toxicity
Language	English
Dates of publication	2020-0410
Size	p. 45-62.
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2020.01.009
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Article ; Online: To PEGylate or not to PEGylate: Immunological properties of nanomedicine's most popular component, polyethylene glycol and its alternatives.

Shi, Da / Beasock, Damian / Fessler, Adam / Szebeni, Janos / Ljubimova, Julia Y / Afonin, Kirill A / Dobrovolskaia, Marina A

Advanced drug delivery reviews

2021 Volume 180, Page(s) 114079

Abstract: Polyethylene glycol or PEG has a long history of use in medicine. Many conventional formulations utilize PEG as either an active ingredient or an excipient. PEG found its use in biotechnology therapeutics as a tool to slow down drug clearance and shield ... ...

Abstract	Polyethylene glycol or PEG has a long history of use in medicine. Many conventional formulations utilize PEG as either an active ingredient or an excipient. PEG found its use in biotechnology therapeutics as a tool to slow down drug clearance and shield protein therapeutics from undesirable immunogenicity. Nanotechnology field applies PEG to create stealth drug carriers with prolonged circulation time and decreased recognition and clearance by the mononuclear phagocyte system (MPS). Most nanomedicines approved for clinical use and experimental nanotherapeutics contain PEG. Among the most recent successful examples are two mRNA-based COVID-19 vaccines that are delivered by PEGylated lipid nanoparticles. The breadth of PEG use in a wide variety of over the counter (OTC) medications as well as in drug products and vaccines stimulated research which uncovered that PEG is not as immunologically inert as it was initially expected. Herein, we review the current understanding of PEG's immunological properties and discuss them in the context of synthesis, biodistribution, safety, efficacy, and characterization of PEGylated nanomedicines. We also review the current knowledge about immunological compatibility of other polymers that are being actively investigated as PEG alternatives.
MeSH term(s)	Animals ; COVID-19 Vaccines/chemistry ; COVID-19 Vaccines/immunology ; Drug Carriers ; Drug Delivery Systems ; Humans ; Nanomedicine ; Polyethylene Glycols/chemistry
Chemical Substances	COVID-19 Vaccines ; Drug Carriers ; Polyethylene Glycols (3WJQ0SDW1A)
Language	English
Publishing date	2021-12-10
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	639113-8
ISSN	1872-8294 ; 0169-409X
ISSN (online)	1872-8294
ISSN	0169-409X
DOI	10.1016/j.addr.2021.114079
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Article ; Online: Biocompatible nanopolymers: the next generation of breast cancer treatment?

Ljubimova, Julia Y / Holler, Eggehard

Nanomedicine (London, England)

2012 Volume 7, Issue 10, Page(s) 1467–1470

MeSH term(s)	Biocompatible Materials ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Female ; Genes, BRCA1 ; Genes, erbB-2 ; Humans ; Nanoparticles ; Precision Medicine
Chemical Substances	Biocompatible Materials
Language	English
Publishing date	2012-11-14
Publishing country	England
Document type	Editorial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2277839-1
ISSN	1748-6963 ; 1743-5889
ISSN (online)	1748-6963
ISSN	1743-5889
DOI	10.2217/nnm.12.115
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Article ; Online: β-Amyloid targeting nanodrug for neuron-specific delivery of nucleic acids in Alzheimer's disease mouse models.

Israel, Liron L / Sun, Tao / Braubach, Oliver / Cox, Alysia / Shatalova, Ekaterina S / Rashid, Harun-Mohammad / Galstyan, Anna / Grodzinski, Zachary / Song, Xue Ying / Chepurna, Oksana / Ljubimov, Vladimir A / Chiechi, Antonella / Sharma, Sachin / Phebus, Connor / Wang, Yizhou / Ljubimova, Julia Y / Black, Keith L / Holler, Eggehard

Journal of controlled release : official journal of the Controlled Release Society

2023 Volume 361, Page(s) 636–658

Abstract: Delivery of therapeutic substances into the brain poses a significant challenge in the treatment of neurological disorders. This is primarily due to the blood-brain barrier (BBB), which restricts access, alongside the limited stability and distribution ... ...

Abstract	Delivery of therapeutic substances into the brain poses a significant challenge in the treatment of neurological disorders. This is primarily due to the blood-brain barrier (BBB), which restricts access, alongside the limited stability and distribution of these agents within the brain tissue. Here we demonstrate an efficient delivery of microRNA (miRNA) and antisense RNA preferentially to neurons compared to astroglia in the brain of healthy and Alzheimer's disease mice, via disulfide-linked conjugation with poly(ß-L-malic acid-trileucine)-copolymer a biodegradable, amphiphilic, and multivalent platform. By conjugating a D-configured (D3)-peptide (vector) for specific targeting, highly efficient delivery across the BBB is achieved through the Low-Density Lipoprotein Receptor-Related Protein-1 (LRP-1) transcytosis pathway, amyloid beta (Aβ) peptides. Nanodrug distribution was determined by fluorescent labeling and analyzed by microscopy in neurons, astroglia, and in extracellular amyloid plaques typical for Alzheimer's disease. Whereas D-configured BBB-vectors can efficiently target neurons, L-configured (e.g., AP2-peptide) guided vector can only cross BBB but not seem to bind neurons. An analysis of post-injection fluorescence distribution, and RNA-seq followed by real-time PCR validation, confirmed a successful in vivo delivery of morpholino-miRNA-186 nanoconjugates into mouse brain. The size and fluorescence intensity of the intracellular nanodrug particulates were analyzed and verified by a competition with non-fluorescent conjugates. Differentially expressed genes (DEGs) from RNA-seq were identified in the nanodrug injected mice, and the changes of selected DEGs related to Alzheimer's disease were further validated by western blot and real-time PCR. Collectively, these results demonstrated that D3-peptide-conjugated nanopolymer drug is able to achieve neuron-selective delivery of miRNA and can serve as an efficient brain delivery vehicle in Alzheimer's disease (AD) mouse models.
MeSH term(s)	Mice ; Animals ; Amyloid beta-Peptides/metabolism ; Alzheimer Disease/metabolism ; Nucleic Acids/therapeutic use ; Brain/metabolism ; Blood-Brain Barrier/metabolism ; Nanoconjugates/therapeutic use ; MicroRNAs/therapeutic use ; Neurons/metabolism ; Disease Models, Animal ; Mice, Transgenic
Chemical Substances	Amyloid beta-Peptides ; Nucleic Acids ; Nanoconjugates ; MicroRNAs
Language	English
Publishing date	2023-08-17
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2023.08.001
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Article ; Online: Applying lessons learned from nanomedicines to understand rare hypersensitivity reactions to mRNA-based SARS-CoV-2 vaccines.

Szebeni, Janos / Storm, Gert / Ljubimova, Julia Y / Castells, Mariana / Phillips, Elizabeth J / Turjeman, Keren / Barenholz, Yechezkel / Crommelin, Daan J A / Dobrovolskaia, Marina A

Nature nanotechnology

2022 Volume 17, Issue 4, Page(s) 337–346

Abstract: After over a billion of vaccinations with messenger RNA-lipid nanoparticle (mRNA-LNP) based SARS-CoV-2 vaccines, anaphylaxis and other manifestations of hypersensitivity can be considered as very rare adverse events. Although current recommendations ... ...

Abstract	After over a billion of vaccinations with messenger RNA-lipid nanoparticle (mRNA-LNP) based SARS-CoV-2 vaccines, anaphylaxis and other manifestations of hypersensitivity can be considered as very rare adverse events. Although current recommendations include avoiding a second dose in those with first-dose anaphylaxis, the underlying mechanisms are unknown; therefore, the risk of a future reaction cannot be predicted. Given how important new mRNA constructs will be to address the emergence of new viral variants and viruses, there is an urgent need for clinical approaches that would allow a safe repeated immunization of high-risk individuals and for reliable predictive tools of adverse reactions to mRNA vaccines. In many aspects, anaphylaxis symptoms experienced by the affected vaccine recipients resemble those of infusion reactions to nanomedicines. Here we share lessons learned over a decade of nanomedicine research and discuss the current knowledge about several factors that individually or collectively contribute to infusion reactions to nanomedicines. We aim to use this knowledge to inform the SARS-CoV-2 lipid-nanoparticle-based mRNA vaccine field.
MeSH term(s)	Anaphylaxis/etiology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Humans ; Liposomes ; Nanomedicine ; Nanoparticles ; RNA, Messenger/genetics ; SARS-CoV-2/genetics ; Vaccines, Synthetic ; mRNA Vaccines
Chemical Substances	COVID-19 Vaccines ; Lipid Nanoparticles ; Liposomes ; RNA, Messenger ; Vaccines, Synthetic ; mRNA Vaccines
Language	English
Publishing date	2022-04-07
Publishing country	England
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2254964-X
ISSN	1748-3395 ; 1748-3387
ISSN (online)	1748-3395
ISSN	1748-3387
DOI	10.1038/s41565-022-01071-x
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Article ; Online: Signature Effects of Vector-Guided Systemic Nano Bioconjugate Delivery Across Blood-Brain Barrier of Normal, Alzheimer's, and Tumor Mouse Models.

Israel, Liron L / Galstyan, Anna / Cox, Alysia / Shatalova, Ekaterina S / Sun, Tao / Rashid, Mohammad-Harun / Grodzinski, Zachary / Chiechi, Antonella / Fuchs, Dieu-Trang / Patil, Rameshwar / Koronyo-Hamaoui, Maya / Black, Keith L / Ljubimova, Julia Y / Holler, Eggehard

ACS nano

2022 Volume 16, Issue 8, Page(s) 11815–11832

Abstract: The ability to cross the blood-brain barrier (BBB) is critical for targeted therapy of the central nerve system (CNS). Six peptide vectors were covalently attached to a 50 kDa poly(β-l-malic acid)-trileucine polymer forming P/LLL(40%)/vector conjugates. ... ...

Abstract	The ability to cross the blood-brain barrier (BBB) is critical for targeted therapy of the central nerve system (CNS). Six peptide vectors were covalently attached to a 50 kDa poly(β-l-malic acid)-trileucine polymer forming P/LLL(40%)/vector conjugates. The vectors were Angiopep-2 (AP2), B6, Miniap-4 (M4), and d-configurated peptides D1, D3, and ACI-89, with specificity for transcytosis receptors low-density lipoprotein receptor-related protein-1 (LRP-1), transferrin receptor (TfR), bee venom-derived ion channel, and Aβ/LRP-1 related transcytosis complex, respectively. The BBB-permeation efficacies were substantially increased ("boosted") in vector conjugates of P/LLL(40%). We have found that the copolymer group binds at the endothelial membrane and, by an allosterically membrane rearrangement, exposes the sites for vector-receptor complex formation. The specificity of vectors is indicated by competition experiments with nonconjugated vectors. P/LLL(40%) does not function as an inhibitor, suggesting that the copolymer binding site is eliminated after binding of the vector-nanoconjugate. The two-step mechanism, binding to endothelial membrane and allosteric exposure of transcytosis receptors, is supposed to be an integral feature of nanoconjugate-transcytosis pathways.
MeSH term(s)	Animals ; Mice ; Blood-Brain Barrier/metabolism ; Alzheimer Disease/pathology ; Nanoconjugates ; Transcytosis ; Peptides/chemistry ; Polymers/pharmacology ; Amyloid beta-Peptides/metabolism
Chemical Substances	Nanoconjugates ; Peptides ; Polymers ; Amyloid beta-Peptides
Language	English
Publishing date	2022-08-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ISSN	1936-086X
ISSN (online)	1936-086X
DOI	10.1021/acsnano.1c10034
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Article ; Online: β-Amyloid targeting nanodrug for neuron-specific delivery of nucleic acids in Alzheimer's disease mouse models

Israel, Liron L. / Sun, Tao / Braubach, Oliver / Cox, Alysia / Shatalova, Ekaterina S. / Rashid, Harun-Mohammad / Galstyan, Anna / Grodzinski, Zachary / Song, Xue Ying / Chepurna, Oksana / Ljubimov, Vladimir A. / Chiechi, Antonella / Sharma, Sachin / Phebus, Connor / Wang, Yizhou / Ljubimova, Julia Y. / Black, Keith L. / Holler, Eggehard

Journal of Controlled Release.

2023

Abstract	Delivery of therapeutic substances into the brain poses a significant challenge in the treatment of neurological disorders. This is primarily due to the blood-brain barrier (BBB), which restricts access, alongside the limited stability and distribution of these agents within the brain tissue. Here we demonstrate an efficient delivery of microRNA (miRNA) and antisense RNA preferentially to neurons compared to astroglia in the brain of healthy and Alzheimer's disease mice, via disulfide-linked conjugation with poly(ß-L-malic acid-trileucine)-copolymer a biodegradable, amphiphilic, and multivalent platform. By conjugating a D-configured (D3)-peptide (vector) for specific targeting, highly efficient delivery across the BBB is achieved through the Low-Density Lipoprotein Receptor-Related Protein-1 (LRP-1) transcytosis pathway, amyloid beta (Aβ) peptides. Nanodrug distribution was determined by fluorescent labeling and analyzed by microscopy in neurons, astroglia, and in extracellular amyloid plaques typical for Alzheimer's disease. Whereas D-configured BBB-vectors can efficiently target neurons, L-configured (e.g., AP2-peptide) guided vector can only cross BBB but not seem to bind neurons. An analysis of post-injection fluorescence distribution, and RNA-seq followed by real-time PCR validation, confirmed a successful in vivo delivery of morpholino-miRNA-186 nanoconjugates into mouse brain. The size and fluorescence intensity of the intracellular nanodrug particulates were analyzed and verified by a competition with non-fluorescent conjugates. Differentially expressed genes (DEGs) from RNA-seq were identified in the nanodrug injected mice, and the changes of selected DEGs related to Alzheimer's disease were further validated by western blot and real-time PCR. Collectively, these results demonstrated that D3-peptide-conjugated nanopolymer drug is able to achieve neuron-selective delivery of miRNA and can serve as an efficient brain delivery vehicle in Alzheimer's disease (AD) mouse models.
Keywords	Alzheimer disease ; Western blotting ; amyloid ; astrocytes ; biodegradability ; blood-brain barrier ; brain ; drugs ; fluorescence ; gene expression regulation ; low density lipoprotein ; mice ; microRNA ; microscopy ; particulates ; peptides ; physiological transport ; quantitative polymerase chain reaction ; sequence analysis ; therapeutics ; Neuron targeting ; Blood-brain barrier ; Nanotechnology ; Nucleic acid delivery ; miRNA ; Alzheimer's disease
Language	English
Publishing place	Elsevier B.V.
Document type	Article ; Online
Note	Pre-press version
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2023.08.001
Database	NAL-Catalogue (AGRICOLA)

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Article: Multifunctional Nanopolymers for Blood-Brain Barrier Delivery and Inhibition of Glioblastoma Growth through EGFR/EGFRvIII, c-Myc, and PD-1.

Patil, Rameshwar / Sun, Tao / Rashid, Mohammad Harun / Israel, Liron L / Ramesh, Arshia / Davani, Saya / Black, Keith L / Ljubimov, Alexander V / Holler, Eggehard / Ljubimova, Julia Y

Nanomaterials (Basel, Switzerland)

2021 Volume 11, Issue 11

Abstract: Glioblastoma (GBM) is the most prevalent primary brain cancer in the pediatric and adult population. It is known as an untreatable tumor in urgent need of new therapeutic approaches. The objective of this work was to develop multifunctional nanomedicines ...

Abstract	Glioblastoma (GBM) is the most prevalent primary brain cancer in the pediatric and adult population. It is known as an untreatable tumor in urgent need of new therapeutic approaches. The objective of this work was to develop multifunctional nanomedicines to treat GBM in clinical practice using combination therapy for several targets. We developed multifunctional nanopolymers (MNPs) based on a naturally derived biopolymer, poly(β-L-malic) acid, which are suitable for central nervous system (CNS) treatment. These MNPs contain several anticancer functional moieties with the capacity of crossing the blood-brain barrier (BBB), targeting GBM cells and suppressing two important molecular markers, tyrosine kinase transmembrane receptors EGFR/EGFRvIII and c-Myc nuclear transcription factor. The reproducible syntheses of MNPs where monoclonal antibodies are replaced with AP-2 peptide for effective BBB delivery were presented. The active anticancer inhibitors of mRNA/protein syntheses were Morpholino antisense oligonucleotides (AONs). Two ways of covalent AON-polymer attachments with and without disulfide bonds were explored. These MNPs bearing AONs to
Language	English
Publishing date	2021-10-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662255-5
ISSN	2079-4991
ISSN	2079-4991
DOI	10.3390/nano11112892
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