Evidence map›Paper›PMID 27314913›Full record

ArticleHuman gene therapy. Clinical development2016

Design of a Phase I Clinical Trial to Evaluate M032, a Genetically Engineered HSV-1 Expressing IL-12, in Patients with Recurrent/Progressive Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma.

Daxa M Patel, Paul M Foreman, L Burt Nabors, Kristen O Riley, G Yancey Gillespie, James M Markert

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Human gene therapy. Clinical development, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 117 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

117 citing papers in PubMed, 1 synthesis or guideline pooled it, 154 citations in OpenAlex.

  1. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
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57 more citing papers are in PubMed but not listed here.

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

6 authors at 1 institution in 1 country.

Daxa M Patel1 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
Paul M Foreman1 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
L Burt Nabors2 Department of Neurology, University of Alabama at Birmingham , Birmingham, Alabama.
Kristen O Riley1 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
G Yancey Gillespie1 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
James M Markert1 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
University of Alabama at Birmingham · US

Funding

Virus Production CoreP01CA071933 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WEICHSELBAUM, RALPH R · 1997 to 2013
$14.5M
Viral and molecular chemotherapy of malignant CNS tumorsP50CA097247 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GILLESPIE, G. YANCEY · 2002 to 2009
$13.5M
Research Training Program in Surgical OncologyT32CA091078 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI KENNEDY, GREGORY DEAN · 2002 to 2017
$4.8M
CONTEMPORARY THERAPEUTICS FOR ANAPLASTIC GLIOMASP20CA151129 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GILLESPIE, G. YANCEY · 2011 to 2013
$2.3M
NCI NIH HHS P01 CA071933NCI NIH HHS P20 CA151129NCI NIH HHS P50 CA097247NCI NIH HHS T32 CA091078
6 · The paper itself

Abstract

M032 is a second-generation oncolytic herpes simplex virus (oHSV) that selectively replicates in tumor cells. M032 kills tumor cells directly through oncolytic replication and then proceeds to infect tumor cells in proximity, continuing the process of tumor destruction. In addition to this direct oncolytic activity, the virus carries a therapeutic payload-thus acting as a gene therapy vector-and causes the tumor cell to synthesize and secrete the immunity-stimulating protein interleukin-12 (IL-12) before cell death. (1) Human IL-12 is expressed and promotes an immune response against surviving tumor cells, increasing the antitumor effect of the therapy. IL-12 also produces an antiangiogenic effect, by interfering with the production of new tumor blood vessels necessary for tumor growth. Thus, M032 oHSV exerts antitumor effects through three distinct potential mechanisms. The virus has also been genetically engineered to minimize toxic effects for the patient. Preclinical animal models support the safety of intracranial inoculation with M032 in two relevant species (mouse and nonhuman primate). This clinical protocol outlines the dose-escalating phase I study for evaluation of M032 in patients with recurrent or progressive malignant glioma.

Indexed as

Oncolytic VirotherapyResearch DesignAstrocytomaBrain NeoplasmsGenetic EngineeringGenetic TherapyGenetic VectorsGlioblastomaGliosarcomaHerpesvirus 1, HumanHumansInterleukin-12Maximum Tolerated DoseNeoplasm Recurrence, LocalOncolytic VirusesPrognosisInterleukin-12

Identifiers

PMID27314913
PMCPMC4932657
OpenAlexW2399245969

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.