NanoViricides, Inc. (OTCBB: NNVC) (the "Company") announced today that it has entered into an agreement with Bioanalytical Systems, Inc. (NASDAQ: BASI) to conduct drug development studies required for submission of Investigational New Drug (IND) applications to the FDA for its nanoviricides® drug candidates against various viral diseases.
The Company has designed the toxicology and safety pharmacology studies that will enable the IND submission and the first-in-human clinical trials of its FluCide® investigational anti-influenza product. BASi will conduct the cGLP and non-GLP studies as required (cGLP = current Good Laboratory Practices). These studies 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 the cardiovascular, respiratory and central nervous systems. These studies are required for US FDA IND submission, as well as for applications to conduct human clinical trials in other countries such as Australia.
The design of the studies was reviewed by the FDA in a pre-IND meeting, as previously announced by the Company.
The Company has previously reported successful results of the Company’s FluCide™ drug candidates in pre-clinical animal studies using two different phylogenetically distinct types of Influenza A, viz. H1N1 and H3N2. The Company has also reported that the drug candidates have been found to be extremely safe in these animal studies. The Company intends to conduct additional efficacy studies as required for the IND application in parallel with the safety/toxicology studies.
The Company anticipates that it will need very large quantities of the drug candidate for these “tox package” studies. The Company has found FluCide to be safe in animals at large dosages, and will need to determine certain safety and toxicology limit parameters. The Company is currently performing scale-up studies in order to produce the necessary quantities of the drug candidate.