Evidence map›Paper›PMID 34103518›Full record

Trial reportNature communications2021

Bladder cancer therapy using a conformationally fluid tumoricidal peptide complex.

Antonín Brisuda, James C S Ho, Pancham S Kandiyal, Justin T-Y Ng, Ines Ambite, Daniel S C Butler, Jaromir Háček, Murphy Lam Yim Wan, Thi Hien Tran, Aftab Nadeem and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03560479 (A Randomized Placebo Controlled Phase I/II Study Evaluating the Safety and Efficacy of alpha1H in Adult Patients With Non-muscle Invasive Bladder Cancer Awaiting Transurethral Surgery), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.8field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03560479 phase1 / phase2unknown statusnot on this map

A Randomized Placebo Controlled Phase I/II Study Evaluating the Safety and Efficacy of alpha1H in Adult Patients With Non-muscle Invasive Bladder Cancer Awaiting Transurethral Surgery

TypeinterventionalSponsorHamlet Pharma ABRan2018 to 2023Enrolled52ConditionsNon-muscle Invasive Bladder CancerArmsalpha1H, 7.4 mg/mL, placebo, alpha1H, 37 mg/mL, alpha1H, 74 mg/mL
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 24 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 4 institutions in 4 countries.

Antonín Brisuda *Department of Urology, Motol University Hospital, 2nd Faculty of Medicine, Charles University Praha, Prague, Czech Republic.
James C S Ho *Division of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.ORCID http://orcid.org/0000-0002-6131-1297
Pancham S KandiyalTrinity Biomedical Sciences Institute (TBSI), School of Biochemistry & Immunology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.
Justin T-Y NgSchool of Biological Sciences, Nanyang Technological University, Singapore, Singapore.
Ines AmbiteDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.ORCID http://orcid.org/0000-0003-1470-671X
Daniel S C ButlerDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.ORCID http://orcid.org/0000-0002-6717-545X
Jaromir HáčekDepartment of Pathology and Molecular Medicine, Motol University Hospital, 2nd Faculty of Medicine, Charles University Praha, Prague, Czech Republic.
Murphy Lam Yim WanDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.
Thi Hien TranDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.
Aftab NadeemDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.
Tuan Hiep TranDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.
Anna HastingsTrinity Biomedical Sciences Institute (TBSI), School of Biochemistry & Immunology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.ORCID http://orcid.org/0000-0002-2236-1232
Petter StormDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.
Daniel L FortunatiTrinity Biomedical Sciences Institute (TBSI), School of Biochemistry & Immunology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.
Parisa EsmaeiliDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden.
Hana NovotnaDepartment of Urology, Motol University Hospital, 2nd Faculty of Medicine, Charles University Praha, Prague, Czech Republic.
Jakub HorňákDepartment of Urology, Motol University Hospital, 2nd Faculty of Medicine, Charles University Praha, Prague, Czech Republic.
Y G MuSchool of Biological Sciences, Nanyang Technological University, Singapore, Singapore.ORCID http://orcid.org/0000-0002-2499-026X
K H MokTrinity Biomedical Sciences Institute (TBSI), School of Biochemistry & Immunology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.ORCID http://orcid.org/0000-0003-3663-2002
Marek BabjukDepartment of Urology, Motol University Hospital, 2nd Faculty of Medicine, Charles University Praha, Prague, Czech Republic.
Catharina SvanborgDivision of Microbiology, Immunology and Glycobiology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, Lund, Sweden. catharina.svanborg@med.lu.se.ORCID http://orcid.org/0000-0001-8145-0553
Lund University · SECharles University · CZTrinity College Dublin · IENanyang Technological University · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Partially unfolded alpha-lactalbumin forms the oleic acid complex HAMLET, with potent tumoricidal activity. Here we define a peptide-based molecular approach for targeting and killing tumor cells, and evidence of its clinical potential (ClinicalTrials.gov NCT03560479). A 39-residue alpha-helical peptide from alpha-lactalbumin is shown to gain lethality for tumor cells by forming oleic acid complexes (alpha1-oleate). Nuclear magnetic resonance measurements and computational simulations reveal a lipid core surrounded by conformationally fluid, alpha-helical peptide motifs. In a single center, placebo controlled, double blinded Phase I/II interventional clinical trial of non-muscle invasive bladder cancer, all primary end points of safety and efficacy of alpha1-oleate treatment are reached, as evaluated in an interim analysis. Intra-vesical instillations of alpha1-oleate triggers massive shedding of tumor cells and the tumor size is reduced but no drug-related side effects are detected (primary endpoints). Shed cells contain alpha1-oleate, treated tumors show evidence of apoptosis and the expression of cancer-related genes is inhibited (secondary endpoints). The results are especially encouraging for bladder cancer, where therapeutic failures and high recurrence rates create a great, unmet medical need.

Indexed as

Amino Acid SequenceApoptosisCell Line, TumorEndocytosisEndpoint DeterminationGene Expression Regulation, NeoplasticHumansOleic AcidsPeptidesPlacebosProtein ConformationProton Magnetic Resonance SpectroscopyThermodynamicsUrinary Bladder NeoplasmsOleic AcidsPeptidesPlacebos

Identifiers

PMID34103518
PMCPMC8187399
OpenAlexW3170883086

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.