BASi will conduct cGLP and non-GLP studies that are designed to assess overall safety in animals receiving multiple doses of FluCide. Specific safety pharmacology studies will also be conducted to assess the effects of FluCide on cardiovascular, respiratory and central nervous systems. These studies are required for IND submission, as well as applications for clinical trials in other countries such as Australia.
NanoViricides anticipates that it will need very large quantities of the drug candidate for these toxicology package studies and is currently performing scale-up studies to produce the necessary quantities. Financial terms of the pact were not disclosed.