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.
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 administ...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0182715&type=printable |
| _version_ | 1826578890167943168 |
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| author | Lukasz Kuryk Lotta Vassilev Tuuli Ranki Akseli Hemminki Aila Karioja-Kallio Onerva Levälampi Antti Vuolanto Vincenzo Cerullo Sari Pesonen |
| author_facet | Lukasz Kuryk Lotta Vassilev Tuuli Ranki Akseli Hemminki Aila Karioja-Kallio Onerva Levälampi Antti Vuolanto Vincenzo Cerullo Sari Pesonen |
| author_sort | Lukasz Kuryk |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-23T03:00:05Z |
| format | Article |
| id | doaj.art-7a9d25a62a6e4a739baaf418b3356f0a |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2025-03-14T14:09:34Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-7a9d25a62a6e4a739baaf418b3356f0a2025-02-27T05:37:38ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01128e018271510.1371/journal.pone.0182715Toxicological 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 KurykLotta VassilevTuuli RankiAkseli HemminkiAila Karioja-KallioOnerva LevälampiAntti VuolantoVincenzo CerulloSari PesonenThe 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.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0182715&type=printable |
| spellingShingle | Lukasz Kuryk Lotta Vassilev Tuuli Ranki Akseli Hemminki Aila Karioja-Kallio Onerva Levälampi Antti Vuolanto Vincenzo Cerullo Sari Pesonen 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. PLoS ONE |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0182715&type=printable |
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