25 January 2021
The oncolytic ECHO-7 virus Rigvir was registered in Latvia in 2004 and later in Georgia, Armenia and Uzbekistan. No severe adverse events have been observed. During drug development good laboratory practice (GLP) pre-clinical toxicology studies are generally required by regulatory agencies. Since such studies had previously not been performed, the aim of this 4-week repeated dose GLP toxicity study was to determine the potential toxicity, and reversibility of any findings after a 4-week treatment-free period.
The results show that there were no significant test item-related adverse events. Therefore, it is concluded that the results suggest that oncolytic ECHO-7 virus Rigvir is safe to administer to rats at the doses used in this study. The dosing regimen used was chosen to mimic the clinical dosing regimen in a condensed manner. Based on the results, the no-observed-adverse-effect level (NOAEL) was considered to be the highest dose tested.
Full publication: https://www.sciencedirect.com/science/article/pii/S2214750021000093
As previously reported in October 2020: Rigvir group company Latima Ltd. has successfully finalised an ERAF funded project – GLP Toxicity Study of RIGVIR. The total duration of the project was 12 months. The total cost was 513471.78 EUR, of which 359430.24 EUR were ERAF funding. The project was performed under contract by Charles River Laboratories UK.