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.
Highlights
Targovax Oy had a role in study design, data collection and Advanced, metastatic tumors often exhibit resistance to standard therapies, and novel, safer and more effective treatment modalities are in high need [1, 2]
This pre-clinical study was performed in compliance with the Organization for Economic Cooperation and Development (OECD), Principles of Good Laboratory Practice (GLP) C (97) 186/Final, Directive 2004/10/EC, The Czech law No 378/2007 and Decree of Ministry of Health and Ministry of Agriculture of the Czech Republic No 86/2008 of Collection of laws about Good Laboratory Practice for testing of drugs
Metastatic tumors exhibit resistance to standard therapies, new and more effective treatment modalities are in high need [1, 2]
Summary
Metastatic tumors often exhibit resistance to standard therapies, and novel, safer and more effective treatment modalities are in high need [1, 2]. Toxicological and bio-distribution profile of oncolytic adenovirus ONCOS-102 analysis, decision to publish, and preparation of the manuscript by supervising, monitoring, funding the study and manuscript preparation. The specific roles of these authors are articulated in the ‘author contributions’ section
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