Evidence map›Paper›PMID 19197324›Full record

ArticleCancer gene therapy2009

An acute toxicology study with INGN 007, an oncolytic adenovirus vector, in mice and permissive Syrian hamsters; comparisons with wild-type Ad5 and a replication-defective adenovirus vector.

D L Lichtenstein, J F Spencer, K Doronin, D Patra, J M Meyer, E V Shashkova, M Kuppuswamy, D Dhar, M A Thomas, A E Tollefson and 3 more

Abstract readComparative Study
In one paragraph

Article in Cancer gene therapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
3.6field-weighted citation impact, top 7% 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

33 citing papers in PubMed, 51 citations in OpenAlex.

  1. Treatment of cancer patients with a serotype 5/3 chimeric oncolytic adenovirus expressing GMCSF.Molecular therapy : the journal of the American Society of Gene Therapy · 2010
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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

13 authors at 4 institutions in 1 country.

D L LichtensteinVirRx, Inc., St Louis, MO 63104, USA.
J F Spencer
K Doronin
D Patra
J M Meyer
E V Shashkova
M Kuppuswamy
D Dhar
M A Thomas
A E Tollefson
L A Zumstein
W S M Wold
K Toth
Saint Louis University · USMayo Clinic · USVirRx (United States) · USWashington University in St. Louis · US

Funding

Hamster Model for Oncolytic Adenovirus VectorsR01CA118022 · NCI · SAINT LOUIS UNIVERSITY · PI WOLD, WILLIAM SM · 2006 to 2010
$1.3M
Adenovirus Replication-Competent Anti-Cancer VectorR42CA081829 · NCI · VIRRX, INC · PI WOLD, WILLIAM SM · 2002 to 2003
$711k
Animal Model for Adenovirus Oncolytic VectorsR41CA108335 · NCI · VIRRX, INC · PI WOLD, WILLIAM SM · 2004 to 2004
$182k
ADENOVIRUS REPLICATION COMPETENT ANTICANCER VECTORR41CA081829 · NCI · VIRRX, INC · PI WOLD, WILLIAM SM · 1999 to 1999
–
NCI NIH HHS CA108335NCI NIH HHS CA118022NCI NIH HHS CA81829NCI NIH HHS R01 CA118022NCI NIH HHS R41 CA081829NCI NIH HHS R41 CA108335NCI NIH HHS R42 CA081829
6 · The paper itself

Abstract

Oncolytic (replication-competent) adenoviruses as anticancer agents provide new, promising tools to fight cancer. In support of a Phase I clinical trial, here we report safety data with INGN 007 (VRX-007), an oncolytic adenovirus with increased anti-tumor efficacy due to overexpression of the adenovirus-encoded ADP protein. Wild-type adenovirus type 5 (Ad5) and a replication-defective version of Ad5 were also studied as controls. A parallel study investigating the biodistribution of these viruses is described elsewhere in this issue. The toxicology experiments were conducted in two species, the Syrian hamster, which is permissive for INGN 007 and Ad5 replication and the poorly permissive mouse. The studies demonstrated that the safety profile of INGN 007 is similar to Ad5. Both viruses caused transient liver damage upon intravenous injection that resolved by 28 days post-infection. The No-Observable-Adverse-Effect-Level (NOAEL) for INGN 007 in hamsters was 3 x 10(10) viral particles per kg. In hamsters, the replication-defective vector caused less toxicity, indicating that replication of Ad vectors in the host is an important factor in pathogenesis. With mice, INGN 007 and Ad5 caused toxicity comparable to the replication-defective adenovirus vector. Partially based on these results, the FDA granted permission to enter into a Phase I clinical trial with INGN 007.

Indexed as

AdenoviridaeAdenovirus E3 ProteinsAnimalsBlood Cell CountCell LineCricetinaeErythropoiesisGenetic VectorsHumansInjections, IntravenousLiverMesocricetusMiceMice, Inbred C57BLOncolytic VirusesVirus Replicationadenovirus death protein, AdenovirusAdenovirus E3 Proteins

Identifiers

PMID19197324
PMCPMC3433943
OpenAlexW1994217611

What OpenQuestion holds

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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.