Evidence map›Paper›PMID 25730754›Full record

ArticleComparative medicine2015

Pathology, organ distribution, and immune response after single and repeated intravenous injection of rats with clinical-grade parvovirus H1.

Karsten Geletneky, Anne-Laure Leoni, Gabriele Pohlmeyer-Esch, Stephanie Loebhard, Andrea Baetz, Barbara Leuchs, Mandy Roscher, Constance Hoefer, Karin Jochims, Michael Dahm and 4 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Comparative medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01301430 (Phase I/IIa Study of Intratumoral/Intracerebral or Intravenous/Intracerebral Administration of Parvovirus H-1), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.0field-weighted citation impact, top 19% 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.

NCT01301430 phase1 / phase2completednot on this map

Phase I/IIa Study of Intratumoral/Intracerebral or Intravenous/Intracerebral Administration of Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.

TypeinterventionalSponsorOryx GmbH & Co. KGRan2011 to 2015Enrolled18ConditionsGlioblastoma MultiformeArmsH-1PV
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 16 citations in OpenAlex.

  1. Oncolytic H-1 Parvovirus Shows Safety and Signs of Immunogenic Activity in a First Phase I/IIa Glioblastoma Trial.Molecular therapy : the journal of the American Society of Gene Therapy · 2017
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 2 countries.

Karsten GeletnekyDepartment of Neurosurgery, University Hospital, Heidelberg, Germany; Department of Applied Tumor Virology, German Cancer Research Center, Heidelberg, Germany. kgeletneky@med.uni-heidelberg.de.
Anne-Laure LeoniBSL BIOSERVICE Scientific Laboratories GmbH, Planegg, Munich, Germany.
Gabriele Pohlmeyer-EschKALEIDIS Consultancy in Histopathology, Saint Louis, France.
Stephanie LoebhardBSL BIOSERVICE Scientific Laboratories GmbH, Planegg, Munich, Germany.
Andrea BaetzBSL BIOSERVICE Scientific Laboratories GmbH, Planegg, Munich, Germany.
Barbara LeuchsDepartment of Applied Tumor Virology, German Cancer Research Center, Heidelberg, Germany.
Mandy RoscherDepartment of Applied Tumor Virology, German Cancer Research Center, Heidelberg, Germany.
Constance HoeferDMPKORE, Ingolstadt, Germany.
Karin JochimsIASON Consulting, Niederzier, Germany.
Michael DahmORYX GmbH and Co KG, Baldham, Germany.
Bernard HuberORYX GmbH and Co KG, Baldham, Germany.
Jean RommelaereDepartment of Applied Tumor Virology, German Cancer Research Center, Heidelberg, Germany.
Ottheinz KrebsORYX GmbH and Co KG, Baldham, Germany.
Jacek HajdaCoordination Center for Clinical Trials, University Hospital, Heidelberg, Germany.
Heidelberg University · DERED Consulting (Norway) · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Parvovirus H1 (H1PV) is an autonomous parvovirus that is transmitted in rodent populations. Its natural host is rats. H1PV infection is nonpathogenic except in rat and hamster fetuses and newborns. H1PV infection of human cancer cells caused strong oncolytic effects in preclinical models. For a clinical trial of H1PV in patients with brain tumors, clinical-grade H1PV was produced according to Good Manufacturing Practices. This report focuses on results obtained after a single high-dose intravenous injection of highly purified H1PV in 30 rats and multiple (n = 17) intravenous injections at 3 dose levels in 223 rats. In both studies, no virus-related mortality or macroscopic organ changes related to H1PV occurred. Histopathology after multiple virus injections revealed minimal diffuse bile duct hyperplasia in livers of animals of the highest dose group and germinal center development in spleens of animals from the high-dose group. Liver changes were reversible within a 2-wk recovery period after the last injection. Hematology, blood chemistry, and coagulation analyses did not reveal significant toxicologic changes due to H1PV. Virus injection stimulated the production of IgG antibodies but did not alter mononuclear cell function or induce cytokine release. PCR analysis showed dose-dependent levels of viral genomes in all organs tested. The virus was excreted primarily through feces. These data provide important information regarding H1PV infection in its natural host. Due to the confirmation of the favorable safety profile of H1PV in a permissive animal model, a phase I/IIa clinical trial of H1PV in brain tumor patients could be initiated.

Indexed as

AnimalsBlood Chemical AnalysisBlood Coagulation TestsDose-Response Relationship, ImmunologicDrug Evaluation, PreclinicalFecesGenome, ViralH-1 parvovirusImmunoglobulin GInjections, IntravenousLiverOncolytic VirotherapyParvoviridae InfectionsPolymerase Chain ReactionRatsSpleenImmunoglobulin G

Identifiers

PMID25730754
PMCPMC4396926
OpenAlexW2232390870

What OpenQuestion holds

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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.