Evidence map›Paper›PMID 28796812›Full record

ArticlePloS one2017

Toxicological and bio-distribution profile of a GM-CSF-expressing, double-targeted, chimeric oncolytic adenovirus ONCOS-102 - Support for clinical studies on advanced cancer treatment.

Lukasz Kuryk, Lotta Vassilev, Tuuli Ranki, Akseli Hemminki, Aila Karioja-Kallio, Onerva Levälampi, Antti Vuolanto, Vincenzo Cerullo, Sari Pesonen

Registry-linked trialAbstract read
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01598129 (Exploratory Open Label Study of GM-CSF Coding Oncolytic Adenovirus CGTG-102, With Low Dose Cyclophosphamide in Patients With Refractory Injectable Solid Tumours), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
–field-weighted citation impact
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.

NCT01598129 phase1completednot on this map

Exploratory Open Label Study of GM-CSF Coding Oncolytic Adenovirus CGTG-102, With Low Dose Cyclophosphamide in Patients With Refractory Injectable Solid Tumours

TypeinterventionalSponsorTargovax OyRan2012 to 2013Enrolled12ConditionsMalignant Solid TumourArmsONCOS-102
3 · Its place in the literature

Who cites it

28 citing papers in PubMed.

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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

9 authors.

Lukasz KurykTargovax Oy, Helsinki, Finland.ORCID http://orcid.org/0000-0003-1887-6361
Lotta VassilevTargovax Oy, Helsinki, Finland.
Tuuli RankiTargovax Oy, Helsinki, Finland.
Akseli HemminkiUniversity of Helsinki, Faculty of Medicine, Department of Pathology, Cancer Gene Therapy Group, Helsinki, Finland.
Aila Karioja-KallioFaculty of Medicine, University of Helsinki, Helsinki, Finland.
Onerva LevälampiFaculty of Medicine, University of Helsinki, Helsinki, Finland.
Antti VuolantoTargovax Oy, Helsinki, Finland.
Vincenzo CerulloImmunoViroTherapy lab, Division of Pharmaceutical Biosciences & Centre for Drug Research, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
Sari PesonenTargovax Oy, Helsinki, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this work was to carry out preclinical toxicity and bio-distribution studies required for regulatory approval of a clinical trial application for Phase I clinical studies of ONCOS-102 (Ad5/3-D24-GM-CSF) for therapy of advanced cancers (NCT01598129). The study design, route of administration and dosage differs from the clinical protocol and in more detail, investigate bio-distribution and toxicological profile of ONCOS-102 treatment in animal model. The study was carried out in 300 hamsters divided into nine test groups-three bio-distribution groups and six groups for analysis of toxicity. Hamsters received ONCOS-102 by intracardial, intraperitoneal or subcutaneous injections. Additionally, one group was administered twice a week with intraperitoneal injections of Cyclophosphamide. The control animals were administered with NaCl solution without ONCOS-102 in the same volume and the same way. No adverse effects of repeated administration of ONCOS-102 including body weight, food consumption, hematology and clinical chemistry parameters, histopathology and bio-accumulation were observed in the course of 6-month administration and following 3- month recovery period. All obtained findings indicate the treatment clinically safe.

Indexed as

Oncolytic VirotherapyAdenoviridaeAnimalsCricetinaeFemaleGranulocyte-Macrophage Colony-Stimulating FactorMaleMesocricetusMolecular Targeted TherapyNeoplasmsOncolytic VirusesTissue DistributionGranulocyte-Macrophage Colony-Stimulating Factor

Identifiers

PMID28796812
PMCPMC5552138

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.