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- 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.
- Authors
Kuryk, Lukasz; Vassilev, Lotta; Ranki, Tuuli; Hemminki, Akseli; Karioja-Kallio, Aila; Levälampi, Onerva; Vuolanto, Antti; Cerullo, Vincenzo; Pesonen, Sari
- 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.
- Subjects
CLINICAL trials; ANIMAL models of cancer; CANCER treatment; CYCLOPHOSPHAMIDE; ADENOVIRUSES
- Publication
PLoS ONE, 2017, Vol 12, Issue 8, p1
- ISSN
1932-6203
- Publication type
Article
- DOI
10.1371/journal.pone.0182715